<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04468659</url>
  </required_header>
  <id_info>
    <org_study_id>BAN2401-G000-303</org_study_id>
    <secondary_id>R01AG054029</secondary_id>
    <secondary_id>R01AG061848</secondary_id>
    <secondary_id>2020-004244-28</secondary_id>
    <nct_id>NCT04468659</nct_id>
  </id_info>
  <brief_title>AHEAD 3-45 Study: A Study to Evaluate Efficacy and Safety of Treatment With Lecanemab in Participants With Preclinical Alzheimer's Disease and Elevated Amyloid and Also in Participants With Early Preclinical Alzheimer's Disease and Intermediate Amyloid</brief_title>
  <official_title>AHEAD 3-45 Study: A Placebo-Controlled, Double-Blind, Parallel-Treatment Arm, 216 Week Study to Evaluate Efficacy and Safety of Treatment With BAN2401 in Subjects With Preclinical Alzheimer's Disease and Elevated Amyloid (A45 Trial) and in Subjects With Early Preclinical Alzheimer's Disease and Intermediate Amyloid (A3 Trial)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Eisai Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Alzheimer's Clinical Trials Consortium</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Biogen</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institute on Aging (NIA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Eisai Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary purpose of this study is to determine whether treatment with lecanemab is&#xD;
      superior to placebo on change from baseline of the Preclinical Alzheimer Cognitive Composite&#xD;
      5 (PACC5) at 216 weeks of treatment (A45 Trial) and to determine whether treatment with&#xD;
      lecanemab is superior to placebo in reducing brain amyloid accumulation as measured by&#xD;
      amyloid positron emission tomography (PET) at 216 weeks of treatment (A3 Trial).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 14, 2020</start_date>
  <completion_date type="Anticipated">October 25, 2027</completion_date>
  <primary_completion_date type="Anticipated">October 25, 2027</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>A45 Trial: Change From Baseline in Preclinical Alzheimer Cognitive Composite 5 (PACC5) Score at Week 216</measure>
    <time_frame>Baseline, Week 216</time_frame>
    <description>PACC5(5 components):Free/cued selective reminding test:number of words recalled without cuing/with cuing(0[worst]-96[best recall]);Delayed Paragraph Recall test: recall of 1 short story(25 bits information),immediately after reading and again after delay of 30 minutes (0[worst]-25[best recall]);Digit-symbol substitution test: Participant uses a key to fill in blank squares as fast as possible in 90 seconds(0[none]-91[best performance]);Mini Mental State Score:to evaluate orientation,memory,attention,concentration,naming,repetition,comprehension and ability to create sentence,to copy 2 overlapping pentagons, scored as number of correctly completed items(0[worse]-30[perfect performance]);Category fluency task: participants generate words in 60 second belonging to a semantic category(total score:number of appropriate words generated per task, higher values indicate better performance).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>A3 Trial: Change From Baseline in Amyloid Positron Emission Tomography (PET) Standard Uptake Value Ratio (SUVr) at Week 216</measure>
    <time_frame>Baseline, Week 216</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>A45 Trial: Change From Baseline in Amyloid Positron Emission Tomography (PET) Standard Uptake Value Ratio (SUVr) at Weeks 96 and 216</measure>
    <time_frame>Baseline, Week 96, Week 216</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>A45 Trial: Change From Baseline in tau Positron Emission Tomography (PET) Standard Uptake Value Ratio (SUVr) at Weeks 96 and 216</measure>
    <time_frame>Baseline, Week 96, Week 216</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>A45 Trial: Change From Baseline in Cognitive Function Index (CFI) at Week 216</measure>
    <time_frame>Baseline, Week 216</time_frame>
    <description>CFI assessment to assess the participant's perceived ability to perform high-level functional tasks in daily life and sense of overall cognitive functional ability. Study participants (18 questions) and their study partners (15 questions) independently rate the participant's abilities. Total score combines participant and study partner scores, with higher scores indicating greater impairment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>A3 Trial: Change From Baseline in tau Positron Emission Tomography (PET) Standard Uptake Value Ratio (SUVr) at Week 216</measure>
    <time_frame>Baseline, Week 216</time_frame>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">1400</enrollment>
  <condition>Preclinical Alzheimer's Disease</condition>
  <condition>Early Preclinical Alzheimer's Disease</condition>
  <arm_group>
    <arm_group_label>A45 Trial: Lecanemab 5 mg/kg + 10 mg/kg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive lecanemab 5 milligram per kilogram (mg/kg), administered as intravenous (IV) infusion, every two weeks from Week 0 to 6, then 10 mg/kg, administered as IV infusion, every two weeks from Week 8 to 94, and 10 mg/kg, administered as IV infusion, every four weeks from Week 96 to 216.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>A45 Trial: Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants will receive placebo (0.9 percent [%] sodium chloride solution), administered as IV infusion, every two weeks from Week 0 to 94, then every four weeks from Week 96 to 216.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>A3 Trial: Lecanemab 5 mg/kg + 10 mg/kg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive lecanemab 5 mg/kg, administered as IV infusion, every four weeks from Week 0 to 4, then 10 mg/kg, administered as IV infusion, every four weeks from Week 8 to 216.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>A3 Trial: Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants will receive placebo (0.9% sodium chloride solution), administered as IV infusion, every four weeks from Week 0 to 216.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lecanemab</intervention_name>
    <description>IV infusion.</description>
    <arm_group_label>A3 Trial: Lecanemab 5 mg/kg + 10 mg/kg</arm_group_label>
    <arm_group_label>A45 Trial: Lecanemab 5 mg/kg + 10 mg/kg</arm_group_label>
    <other_name>BAN2401</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>IV infusion.</description>
    <arm_group_label>A3 Trial: Placebo</arm_group_label>
    <arm_group_label>A45 Trial: Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
        Participants must meet all of the following criteria to be included in this study:&#xD;
&#xD;
          1. Male or female, age 55 to 80 years inclusive at the time of informed consent, with a&#xD;
             plasma biomarker result that is predictive of intermediate or elevated brain amyloid&#xD;
             at Screening or known before Screening to have elevated or intermediate amyloid&#xD;
             according to previous PET, cerebrospinal fluid (CSF), or plasma testing&#xD;
&#xD;
             • Those 55 to 64 must have 1 of the following additional risk factors, given the&#xD;
             relatively low rates of amyloid positivity less than (&lt;) 65 years, before screening:&#xD;
&#xD;
               -  First degree relative diagnosed with dementia onset before age 75, or&#xD;
&#xD;
               -  Known to possess at least 1 apolipoprotein E4 variant (APOE4) allele, or&#xD;
&#xD;
               -  Known before screening to have elevated brain amyloid according to previous PET&#xD;
                  or CSF testing&#xD;
&#xD;
          2. Global Clinical Dementia Rating (CDR) score of 0 at screening&#xD;
&#xD;
          3. Mini Mental State Examination score greater than or equal to (&gt;=) 27 (with educational&#xD;
             adjustments) at screening.&#xD;
&#xD;
          4. Wechsler Memory Scale-Revised Logical Memory subscale II (WMS-R LM II) score at&#xD;
             screening of &gt;=6&#xD;
&#xD;
          5. A45 Trial: Elevated brain amyloid pathology by amyloid PET: defined as approximately&#xD;
             greater than (&gt;) 40 Centiloids on screening scan A3 Trial: Intermediate levels of&#xD;
             brain amyloid pathology by amyloid PET: defined as approximately 20 to 40 Centiloids&#xD;
             on screening scan&#xD;
&#xD;
          6. Has a study partner that is willing to participate as a source of information and has&#xD;
             approximately weekly contact with the participant (contact can be in-person, via&#xD;
             telephone or electronic communication). The study partner must have sufficient contact&#xD;
             such that the investigator feels the study partner can provide meaningful information&#xD;
             about the participant's daily function&#xD;
&#xD;
          7. Provide written (or electronic, if allowed per country-specific regulations) informed&#xD;
             consent&#xD;
&#xD;
          8. Willing and able to comply with all aspects of the protocol&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
        Participants who meet any of the following criteria will be excluded from this study:&#xD;
&#xD;
          1. Females who are breastfeeding or pregnant at screening or baseline&#xD;
&#xD;
          2. Females of childbearing potential who:&#xD;
&#xD;
             • Within 28 days before study entry, did not use a highly effective method of&#xD;
             contraception For sites outside of Europe, it is permissible that if a highly&#xD;
             effective method of contraception is not appropriate or acceptable to the participant,&#xD;
             then the participant must agree to use a medically acceptable method of contraception&#xD;
&#xD;
          3. History of transient ischemic attacks (TIA), stroke, or seizures within 12 months of&#xD;
             screening&#xD;
&#xD;
          4. Current or history within the past 2 years of psychiatric diagnosis or symptoms that,&#xD;
             in the opinion of the investigator, could interfere with study procedures&#xD;
&#xD;
          5. Contraindications to 3 Tesla magnetic resonance imaging (MRI) scanning, including&#xD;
             cardiac pacemaker/defibrillator, ferromagnetic metal implants (example, in-skull and&#xD;
             cardiac devices other than those approved as safe for use in MRI scanners), or exhibit&#xD;
             other significant pathological findings on brain MRI at Screening&#xD;
&#xD;
          6. Hypersensitivity to any monoclonal antibody treatment&#xD;
&#xD;
          7. Any immunological disease which is not adequately controlled, or which requires&#xD;
             treatment with immunoglobulins, systemic monoclonal antibodies (or derivatives of&#xD;
             monoclonal antibodies), systemic immunosuppressants, or plasmapheresis during the&#xD;
             study&#xD;
&#xD;
          8. Bleeding disorder that is not under adequate control (including a platelet count&#xD;
             &lt;50,000 or international normalized ratio [INR] &gt;1.5) at screening&#xD;
&#xD;
          9. Results of laboratory tests conducted during screening that are outside the following&#xD;
             limits:&#xD;
&#xD;
               -  Thyroid stimulating hormone (TSH) above normal range&#xD;
&#xD;
               -  Abnormally low (below lower limit of normal [LLN]) serum vitamin B12 levels for&#xD;
                  the testing laboratory (if participant is taking vitamin B12 injections, level&#xD;
                  should be at or above the LLN for the testing laboratory). A low vitamin B12 is&#xD;
                  exclusionary, unless the required follow-up labs (homocysteine and methylmalonic&#xD;
                  acid [MMA]) indicate that it is not physiologically significant&#xD;
&#xD;
         10. Known to be human immunodeficiency virus (HIV) positive&#xD;
&#xD;
         11. Any other clinically significant abnormalities that in the opinion of the investigator&#xD;
             require further investigation or treatment or may interfere with study procedures or&#xD;
             safety&#xD;
&#xD;
         12. Malignant neoplasms within 3 years of screening (except for basal or squamous cell&#xD;
             carcinoma in situ of the skin, or localized prostate cancer in male participants with&#xD;
             treatment cycles completed at least 6 months before screening). Participants who had&#xD;
             malignant neoplasms but who have had at least 3 years of documented uninterrupted&#xD;
             remission before screening need not be excluded&#xD;
&#xD;
         13. Answer &quot;yes&quot; to Columbia-Suicide Severity Rating Scale (C-SSRS) suicidal ideation Type&#xD;
             4 or 5, or any suicidal behavior assessment within 6 months before screening, at&#xD;
             screening, or at baseline, or has been hospitalized or treated for suicidal behavior&#xD;
             in the past 5 years before screening&#xD;
&#xD;
         14. Known or suspected history of drug or alcohol abuse or dependence within 2 years&#xD;
             before screening or a positive urine drug test at screening. Participants who test&#xD;
             positive for benzodiazepines, opioids, or tetrahydrocannabinol (THC) in urine drug&#xD;
             testing need not be excluded unless in the clinical opinion of the investigator this&#xD;
             is due to potential drug abuse&#xD;
&#xD;
         15. Taking prohibited medications&#xD;
&#xD;
         16. Participation in a clinical study involving:&#xD;
&#xD;
               -  Any anti-amyloid immunotherapy (example, therapeutic monoclonal antibody or&#xD;
                  active anti-amyloid vaccine) at any time, unless it can be documented that the&#xD;
                  participant was randomized to placebo or never received study drug&#xD;
&#xD;
               -  Any immunoglobulin therapy, or vaccine within 6 months before Screening, unless&#xD;
                  it can be documented that the participant was randomized to placebo or never&#xD;
                  received study drug&#xD;
&#xD;
               -  Lecanemab&#xD;
&#xD;
               -  Any new chemical entities or investigational drug for AD within 6 months before&#xD;
                  screening unless it can be documented that the participant received only placebo&#xD;
&#xD;
               -  Any other investigational medication or device study in the 8 weeks or 5&#xD;
                  half-lives (whichever is longer) of the medication before randomization unless it&#xD;
                  can be documented that the participant was in a placebo treatment arm&#xD;
&#xD;
         17. Planned surgery during the pre-randomization phase or within 3 months of&#xD;
             randomization, which requires general anesthesia&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>55 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Eisai Medical Information</last_name>
    <phone>+1-888-274-2378</phone>
    <email>esi_medinfo@eisai.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>ACTC Recruitment Unit</last_name>
    <email>ahead-participate@usc.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University of Alabama, Birmingham</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35233</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Banner Alzheimer's Institute</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85006</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Banner Sun Health Research Institute</name>
      <address>
        <city>Sun City</city>
        <state>Arizona</state>
        <zip>85351</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>UCI MIND</name>
      <address>
        <city>Irvine</city>
        <state>California</state>
        <zip>92697-4285</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>University of Southern California</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90033</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hoag Memorial Hospital Presbyterian</name>
      <address>
        <city>Newport Beach</city>
        <state>California</state>
        <zip>92663</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Stanford University</name>
      <address>
        <city>Palo Alto</city>
        <state>California</state>
        <zip>94304</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Sharp Mesa Vista Hospital</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92123</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Univeristy of California, San Francisco</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94158</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>University of California, Davis</name>
      <address>
        <city>Walnut Creek</city>
        <state>California</state>
        <zip>94598</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Yale University School of Medicine</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06510</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Georgetown University</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20057</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Howard University</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20060</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Advanced Clinical Research Network, Corp</name>
      <address>
        <city>Coral Gables</city>
        <state>Florida</state>
        <zip>33134-1613</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Brain Matters Research</name>
      <address>
        <city>Delray Beach</city>
        <state>Florida</state>
        <zip>33445</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic Jacksonville</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32224</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>K2 Medical Research</name>
      <address>
        <city>Maitland</city>
        <state>Florida</state>
        <zip>32751</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Wien Center for Clinical Research</name>
      <address>
        <city>Miami Beach</city>
        <state>Florida</state>
        <zip>33140</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Gonzalez MD &amp; Aswad MD Health Sciences</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33125</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Renstar Medical Research</name>
      <address>
        <city>Ocala</city>
        <state>Florida</state>
        <zip>34470</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Synexus Clinical Research</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32806</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Progressive Medical Research</name>
      <address>
        <city>Port Orange</city>
        <state>Florida</state>
        <zip>32127</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>University of South Florida - Health Byrd Alzheimer Institute</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33613</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Synexus Clinical Research</name>
      <address>
        <city>The Villages</city>
        <state>Florida</state>
        <zip>32162</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Alzheimer's Research and Treatment Center</name>
      <address>
        <city>Wellington</city>
        <state>Florida</state>
        <zip>33414</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Charter Research</name>
      <address>
        <city>Winter Park</city>
        <state>Florida</state>
        <zip>31792</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Emory University</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30329</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Columbus Memory Center, PC</name>
      <address>
        <city>Columbus</city>
        <state>Georgia</state>
        <zip>31909</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Northwestern University</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Rush University Medical Center</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60612</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Indiana University School of Medicine</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46202</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>University of Kansas</name>
      <address>
        <city>Fairway</city>
        <state>Kansas</state>
        <zip>66205</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>University of Kentucky</name>
      <address>
        <city>Lexington</city>
        <state>Kentucky</state>
        <zip>40504</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Johns Hopkins University</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21224</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Boston University</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02118</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Brigham and Woman's Hospital Center for Alzheimer Research and Treatment</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>21155</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Donald S.Marks, M.D.,P.C.</name>
      <address>
        <city>Plymouth</city>
        <state>Massachusetts</state>
        <zip>02360</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>University of Michigan (UMICH)</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48105</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic, Rochester</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Washington University</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63108</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Cleveland Clinic Lou Ruvo Center for Brain Health</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89106</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Advanced Memory Research Institute of New Jersey</name>
      <address>
        <city>Toms River</city>
        <state>New Jersey</state>
        <zip>08755</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Icahn School of Medicine at Mount Sinai</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Columbia University</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>University of Rochester</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14620</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Duke Health Center</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27705</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>AMC Research</name>
      <address>
        <city>Matthews</city>
        <state>North Carolina</state>
        <zip>28105</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Wake Forest University Health Sciences</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27157</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Case Western Reserve University/University Hospitals</name>
      <address>
        <city>Beachwood</city>
        <state>Ohio</state>
        <zip>44122</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Cleveland Clinic Lou Ruvo Center for Brain Health</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Ohio State University</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Central States Research, LLC</name>
      <address>
        <city>Tulsa</city>
        <state>Oklahoma</state>
        <zip>74136</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Summit Research Network, Oregon</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97210</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Oregon Health &amp; Science University</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97239</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Abington Neurological Associates</name>
      <address>
        <city>Abington</city>
        <state>Pennsylvania</state>
        <zip>19001</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Keystone Clinical Studies, LLC</name>
      <address>
        <city>Norristown</city>
        <state>Pennsylvania</state>
        <zip>19403</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>University of Pennsylvania</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>University of Pittsburgh</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15213</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Rhode Island Hospital</name>
      <address>
        <city>Providence</city>
        <state>Rhode Island</state>
        <zip>02903</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Butler Hospital Memory and Aging Program</name>
      <address>
        <city>Providence</city>
        <state>Rhode Island</state>
        <zip>02906</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Ralph H. Johnson VA Medical Center</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>20403</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Roper St. Francis Healthcare</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29401</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Neurology Clinic, P.C.</name>
      <address>
        <city>Cordova</city>
        <state>Tennessee</state>
        <zip>38018</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Vanderbilt University Medical Center</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37212</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>University of Texas, Southwestern MC at Dallas</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75390</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>University of North Texas Health Sciences Center</name>
      <address>
        <city>Fort Worth</city>
        <state>Texas</state>
        <zip>76107</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Baylor College of Medicine</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Houston Methodist Neurological Institute</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>The University of Texas Health Science Center at San Antonio</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229-3900</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Eastern Virginia Medical School</name>
      <address>
        <city>Norfolk</city>
        <state>Virginia</state>
        <zip>23507</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>National Clinical Research, Inc</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23294</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>University of Washington Memory and Brain Wellness Center</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98104</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>SIBCR</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98108</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>University of Wisconsin</name>
      <address>
        <city>Madison</city>
        <state>Wisconsin</state>
        <zip>53792</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>St Vincent's Hospital Sydney</name>
      <address>
        <city>Darlinghurst</city>
        <state>New South Wales</state>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Calvary Mater Newcastle</name>
      <address>
        <city>Waratah</city>
        <state>New South Wales</state>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Westmead Hospital</name>
      <address>
        <city>Westmead</city>
        <state>New South Wales</state>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>CALHN Memory Trials</name>
      <address>
        <city>Adelaide</city>
        <state>South Australia</state>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Austin Hospital - Medical and Cognitive Research Unit</name>
      <address>
        <city>Ivanhoe</city>
        <state>Victoria</state>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Australian Alzheimer's Research Foundation</name>
      <address>
        <city>Nedlands</city>
        <state>Western Australia</state>
        <zip>6009</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>True North Clinical Research Inc.</name>
      <address>
        <city>New Minas</city>
        <state>Nova Scotia</state>
        <zip>B4N 3R7</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Parkwood Institute Main Building</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <zip>N6C0A7</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Toronto Memory Program</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M3B 2S7</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Sunnybrook Health Sciences Centre</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M4N 3M5</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>McGill University / Jewish General Hospital Memory Clinic</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H3T 1E2</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Eisai Trial Site #2</name>
      <address>
        <city>Obu-shi</city>
        <state>Aichi</state>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Eisai Trial Site #9</name>
      <address>
        <city>Fukuoka-shi</city>
        <state>Fukuoka</state>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Kobe University Hospital</name>
      <address>
        <city>Kobe-shi</city>
        <state>Hyogo</state>
        <zip>650-0017</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Eisai Trial Site #10</name>
      <address>
        <city>Kamakura-shi</city>
        <state>Kanagawa</state>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Koseikai Takeda Hospital</name>
      <address>
        <city>Kyoto-shi</city>
        <state>Kyoto</state>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Eisai Trial Site #5</name>
      <address>
        <city>Sendai-shi</city>
        <state>Miyagi</state>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Eisai Trial Site #6</name>
      <address>
        <city>Osaka-shi</city>
        <state>Osaka</state>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Eisai Trial Site #12</name>
      <address>
        <city>Suita-shi</city>
        <state>Osaka</state>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Eisai Trial Site #4</name>
      <address>
        <city>Bunkyo-ku</city>
        <state>Tokyo</state>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Eisai Trial Site #1</name>
      <address>
        <city>Hachioji -shi</city>
        <state>Tokyo</state>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Eisai Trial Site #7</name>
      <address>
        <city>Itabashi-ku</city>
        <state>Tokyo</state>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Eisai Trial Site #8</name>
      <address>
        <city>Kodaira-shi</city>
        <state>Tokyo</state>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Eisai Trial Site #3</name>
      <address>
        <city>Shinjuku-Ku</city>
        <state>Tokyo</state>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Brain Research Center</name>
      <address>
        <city>Amsterdam</city>
        <zip>01000</zip>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>National University Hospital</name>
      <address>
        <city>Singapore</city>
        <country>Singapore</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Barcelona Beta Brain Research Center</name>
      <address>
        <city>Barcelona</city>
        <zip>08005</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Fundació ACE</name>
      <address>
        <city>Barcelona</city>
        <zip>08028</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Quirón Salud Madrid</name>
      <address>
        <city>Madrid</city>
        <zip>28223</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Fundacion CITA ALZHEIMER</name>
      <address>
        <city>San Sebastian</city>
        <zip>20009</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Marqués de Valdeciila</name>
      <address>
        <city>Santander</city>
        <zip>39008</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Memory Clinic, Skåne University Hospital</name>
      <address>
        <city>Malmo</city>
        <zip>21428</zip>
        <country>Sweden</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
  </location>
  <location>
    <facility>
      <name>Memory Clinic Sahlgrenska University Hospital</name>
      <address>
        <city>Molndal</city>
        <zip>42830</zip>
        <country>Sweden</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
  </location>
  <location>
    <facility>
      <name>Bristol Brain Centre</name>
      <address>
        <city>Bristol</city>
        <zip>BS10 5NB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Glasgow Memory Clinic</name>
      <address>
        <city>Glasgow</city>
        <zip>ML1 4UF</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>St Pancras Clinical Research</name>
      <address>
        <city>London</city>
        <zip>EC2Y 8EA</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Imperial Memory Unit</name>
      <address>
        <city>London</city>
        <zip>W6 8RF</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Canada</country>
    <country>Japan</country>
    <country>Netherlands</country>
    <country>Singapore</country>
    <country>Spain</country>
    <country>Sweden</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>July 9, 2020</study_first_submitted>
  <study_first_submitted_qc>July 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 13, 2020</study_first_posted>
  <last_update_submitted>June 27, 2023</last_update_submitted>
  <last_update_submitted_qc>June 27, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 28, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>BAN2401</keyword>
  <keyword>Preclinical Alzheimer's disease</keyword>
  <keyword>Elevated amyloid</keyword>
  <keyword>Early preclinical Alzheimer's disease</keyword>
  <keyword>Intermediate amyloid</keyword>
  <keyword>A45 Trial</keyword>
  <keyword>A3 Trial</keyword>
  <keyword>AHEAD 3-45</keyword>
  <keyword>Lecanemab</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alzheimer Disease</mesh_term>
    <mesh_term>Amyloidosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04468659
org study id: BAN2401-G000-303
secondary id: R01AG054029
secondary id: R01AG061848
secondary id: 2020-004244-28
nct id: NCT04468659
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The primary purpose of this study is to determine whether treatment with lecanemab is
      superior to placebo on change from baseline of the Preclinical Alzheimer Cognitive Composite
      5 (PACC5) at 216 weeks of treatment (A45 Trial) and to determine whether treatment with
      lecanemab is superior to placebo in reducing brain amyloid accumulation as measured by
      amyloid positron emission tomography (PET) at 216 weeks of treatment (A3 Trial).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: A45 Trial: Change From Baseline in Preclinical Alzheimer Cognitive Composite 5 (PACC5) Score at Week 216
time frame: Baseline, Week 216
description: PACC5(5 components):Free/cued selective reminding test:number of words recalled without cuing/with cuing(0[worst]-96[best recall]);Delayed Paragraph Recall test: recall of 1 short story(25 bits information),immediately after reading and again after delay of 30 minutes (0[worst]-25[best recall]);Digit-symbol substitution test: Participant uses a key to fill in blank squares as fast as possible in 90 seconds(0[none]-91[best performance]);Mini Mental State Score:to evaluate orientation,memory,attention,concentration,naming,repetition,comprehension and ability to create sentence,to copy 2 overlapping pentagons, scored as number of correctly completed items(0[worse]-30[perfect performance]);Category fluency task: participants generate words in 60 second belonging to a semantic category(total score:number of appropriate words generated per task, higher values indicate better performance).
measure: A3 Trial: Change From Baseline in Amyloid Positron Emission Tomography (PET) Standard Uptake Value Ratio (SUVr) at Week 216
time frame: Baseline, Week 216
measure: A45 Trial: Change From Baseline in Amyloid Positron Emission Tomography (PET) Standard Uptake Value Ratio (SUVr) at Weeks 96 and 216
time frame: Baseline, Week 96, Week 216
measure: A45 Trial: Change From Baseline in tau Positron Emission Tomography (PET) Standard Uptake Value Ratio (SUVr) at Weeks 96 and 216
time frame: Baseline, Week 96, Week 216
measure: A45 Trial: Change From Baseline in Cognitive Function Index (CFI) at Week 216
time frame: Baseline, Week 216
description: CFI assessment to assess the participant's perceived ability to perform high-level functional tasks in daily life and sense of overall cognitive functional ability. Study participants (18 questions) and their study partners (15 questions) independently rate the participant's abilities. Total score combines participant and study partner scores, with higher scores indicating greater impairment.
measure: A3 Trial: Change From Baseline in tau Positron Emission Tomography (PET) Standard Uptake Value Ratio (SUVr) at Week 216
time frame: Baseline, Week 216
arm group label: A45 Trial: Lecanemab 5 mg/kg + 10 mg/kg
arm group type: Experimental
description: Participants will receive lecanemab 5 milligram per kilogram (mg/kg), administered as intravenous (IV) infusion, every two weeks from Week 0 to 6, then 10 mg/kg, administered as IV infusion, every two weeks from Week 8 to 94, and 10 mg/kg, administered as IV infusion, every four weeks from Week 96 to 216.
arm group label: A45 Trial: Placebo
arm group type: Placebo Comparator
description: Participants will receive placebo (0.9 percent [%] sodium chloride solution), administered as IV infusion, every two weeks from Week 0 to 94, then every four weeks from Week 96 to 216.
arm group label: A3 Trial: Lecanemab 5 mg/kg + 10 mg/kg
arm group type: Experimental
description: Participants will receive lecanemab 5 mg/kg, administered as IV infusion, every four weeks from Week 0 to 4, then 10 mg/kg, administered as IV infusion, every four weeks from Week 8 to 216.
arm group label: A3 Trial: Placebo
arm group type: Placebo Comparator
description: Participants will receive placebo (0.9% sodium chloride solution), administered as IV infusion, every four weeks from Week 0 to 216.
intervention type: Drug
intervention name: Lecanemab
description: IV infusion.
arm group label: A3 Trial: Lecanemab 5 mg/kg + 10 mg/kg
arm group label: A45 Trial: Lecanemab 5 mg/kg + 10 mg/kg
other name: BAN2401
intervention type: Drug
intervention name: Placebo
description: IV infusion.
arm group label: A3 Trial: Placebo
arm group label: A45 Trial: Placebo
criteria: 
gender: All
minimum age: 55 Years
maximum age: 80 Years
healthy volunteers: No
last name: Eisai Medical Information
phone: +1-888-274-2378
email: esi_medinfo@eisai.com
last name: ACTC Recruitment Unit
email: ahead-participate@usc.edu
facility: 
status: Recruiting
facility: 
status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Withdrawn
facility: 
status: Withdrawn
facility: 
status: Recruiting
facility: 
status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Withdrawn
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Not yet recruiting
facility: 
status: Not yet recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
country: Australia
country: Canada
country: Japan
country: Netherlands
country: Singapore
country: Spain
country: Sweden
country: United Kingdom
country: United States
responsible party type: Sponsor
mesh term: Alzheimer Disease
mesh term: Amyloidosis
sharing ipd: Yes
ipd description: Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.