<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/NCT04445831</url>
  </required_header>
  <id_info>
    <org_study_id>ACI-35-1802</org_study_id>
    <secondary_id>2018-004573-27</secondary_id>
    <nct_id>NCT04445831</nct_id>
  </id_info>
  <brief_title>A Study to Evaluate the Safety, Tolerability and Immunogenicity of Tau Targeted Vaccines in Participants With Early Alzheimer's Disease</brief_title>
  <official_title>A Phase Ib/IIa Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Immunogenicity of Different Doses, Regimens and Combinations of Tau Targeted Vaccines in Subjects With Early Alzheimer's Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AC Immune SA</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Janssen Research &amp; Development, LLC</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>AC Immune SA</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is a multicenter, double blind, randomized, placebo-controlled study to evaluate&#xD;
      the safety, tolerability and immunogenicity of different doses, regimens and combinations of&#xD;
      Tau targeted vaccines in participants with early Alzheimer's Disease.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">July 31, 2019</start_date>
  <completion_date type="Anticipated">October 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">October 31, 2023</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of participants with Adverse Events (AEs) assessed by intensity (mild, moderate or severe) and causal relationship (unrelated, unlikely, possibly or probably related)</measure>
    <time_frame>from screening up to week 74</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline in anti-phosphorylated Tau IgG titers in blood</measure>
    <time_frame>from baseline up to week 74</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean change from baseline in systolic and diastolic blood pressure (mmHg)</measure>
    <time_frame>from baseline up to week 74</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean change from baseline in heart rate (bpm)</measure>
    <time_frame>from baseline up to week 74</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean change from baseline in body temperature (degree Celsius)</measure>
    <time_frame>from baseline up to week 74</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants reporting suicidal ideation or behavior using Columbia-Suicide Severity Rating Scale (C-SSRS)</measure>
    <time_frame>from baseline up to week 74</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants with abnormal MRI results</measure>
    <time_frame>from baseline up to week 74</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in anti-Tau IgG titers in blood</measure>
    <time_frame>from baseline up to week 74</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in anti-phosphorylated Tau IgM titers in blood</measure>
    <time_frame>from baseline up to week 74</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in anti-Tau IgM titers in blood</measure>
    <time_frame>from baseline up to week 74</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Change from baseline of functional performance using Clinical Dementia Rating scale Sum of Boxes (CDR-SB)</measure>
    <time_frame>from baseline up to week 74</time_frame>
    <description>The score ranges from 0 to 18. A higher score indicates a worse outcome.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change from baseline of cognitive performance using Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)</measure>
    <time_frame>from baseline up to week 74</time_frame>
    <description>The total scale index score ranges from 40 to 160. A higher score indicates a better outcome.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change from baseline of behavior using Neuropsychiatric Inventory Scale (NPI)</measure>
    <time_frame>from baseline up to week 74</time_frame>
    <description>The score ranges from 0 to 144. A higher score indicates a worse outcome.</description>
  </other_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Actual">57</enrollment>
  <condition>Alzheimer's Disease</condition>
  <condition>Cognitive Impairment</condition>
  <condition>Tauopathies</condition>
  <condition>Mild Cognitive Impairment</condition>
  <condition>Dementia</condition>
  <condition>Brain Diseases</condition>
  <condition>Central Nervous System Diseases</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo administered at predefined time points over a 48-week period.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ACI-35.030 - Low dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Active vaccine administered at predefined time points over a 48-week period.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ACI-35.030 - Medium dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Active vaccine administered at predefined time points over a 48-week period.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ACI-35.030 - High dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Active vaccine administered at predefined time points over a 48-week period.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>JACI-35.054 - Low dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Active vaccine administered at predefined time points over a 48-week period.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>JACI-35.054 - Medium dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Active vaccine administered at predefined time points over a 48-week period.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>ACI-35.030</intervention_name>
    <description>Administration of a Low dose of ACI-35.030</description>
    <arm_group_label>ACI-35.030 - Low dose</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>ACI-35.030</intervention_name>
    <description>Administration of a Medium dose of ACI-35.030</description>
    <arm_group_label>ACI-35.030 - Medium dose</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>ACI-35.030</intervention_name>
    <description>Administration of a High dose of ACI-35.030</description>
    <arm_group_label>ACI-35.030 - High dose</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Administration of Placebo</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>JACI-35.054</intervention_name>
    <description>Administration of a Low dose of JACI-35.054</description>
    <arm_group_label>JACI-35.054 - Low dose</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>JACI-35.054</intervention_name>
    <description>Administration of a Medium dose of JACI-35.054</description>
    <arm_group_label>JACI-35.054 - Medium dose</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or female with age from 50 and up to 75 years old inclusive.&#xD;
&#xD;
          2. Mild Cognitive Impairment (MCI) due to AD or Mild AD according to NIA-AA criteria and&#xD;
             Clinical Dementia Rating scale (CDR) global score of 0.5 or 1 respectively.&#xD;
&#xD;
          3. Mini Mental State Examination (MMSE) score of 22 or above.&#xD;
&#xD;
          4. Abnormal level of CSF Abeta amyloid 42 (Aß42) consistent with AD pathology at&#xD;
             screening.&#xD;
&#xD;
          5. Subjects either not taking any marketed treatment for AD or receiving a stable dose of&#xD;
             an acetylcholinesterase inhibitor and/or memantine for at least 3 months prior to&#xD;
             baseline.&#xD;
&#xD;
          6. Subjects cared for by a reliable informant or caregiver to assure compliance, assist&#xD;
             with clinical assessments and report safety issues.&#xD;
&#xD;
          7. Women must be post-menopausal for at least one year and/or surgically sterilized.&#xD;
&#xD;
          8. Subjects who in the opinion of the investigator is able to understand and provide&#xD;
             written informed consent.&#xD;
&#xD;
          9. Both subject and informant or caregiver must be fluent in one of the languages of the&#xD;
             study and able to comply with all study procedures, including lumbar punctures.&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          1. Participation in previous clinical trials for AD and/or for neurological disorders&#xD;
             using active immunization unless there is documented evidence that the subject was&#xD;
             treated with placebo only and the placebo vaccine is not expected to induce any&#xD;
             specific immune response.&#xD;
&#xD;
          2. Participation in previous clinical trials for AD and/or for neurological disorders&#xD;
             using any passive immunization within the past 6 months (or 5 half-lives of the&#xD;
             investigational antibody, whichever is longer) prior to screening unless there is&#xD;
             documented evidence that the subject was treated with placebo only and the placebo is&#xD;
             not expected to induce any specific immune response.&#xD;
&#xD;
          3. Participation in previous clinical trials for AD and/or for neurological disorders&#xD;
             using any small molecule drug including BACE-1 inhibitors within the past 3 months&#xD;
             prior to screening.&#xD;
&#xD;
          4. Concomitant participation in any other clinical trial using experimental or approved&#xD;
             medications or therapies.&#xD;
&#xD;
          5. Presence of positive Anti-nuclear Antibody (ANA) titers at a dilution of at least&#xD;
             1:160 in subjects without clinical symptoms of auto-immune disease.&#xD;
&#xD;
          6. Current or past history of auto-immune disease, or clinical symptoms consistent with&#xD;
             the presence of auto-immune disease.&#xD;
&#xD;
          7. Immune suppression including but not limited to the use of immunosuppressive drugs or&#xD;
             systemic steroids unless they have been prescribed transiently more than 3 months&#xD;
             prior to screening.&#xD;
&#xD;
          8. History of severe allergic reaction (e.g., anaphylaxis) including but not limited to&#xD;
             severe allergic reaction to previous vaccines and/or medications.&#xD;
&#xD;
          9. Prior history of clinically significant hypoglycaemic episodes.&#xD;
&#xD;
         10. Drug or alcohol abuse or dependence currently met or within the past five years&#xD;
             according to Diagnostic and Statistical Manual of Mental Disorders-V (DSM-V) criteria.&#xD;
&#xD;
         11. Any clinically significant medical condition likely to interfere with the evaluation&#xD;
             of safety and tolerability of the study treatment and/or the adherence to the full&#xD;
             study visit schedule.&#xD;
&#xD;
         12. Any clinically significant medical condition likely to impact the immune system (e.g,&#xD;
             any history of acquired or innate immune system disorder).&#xD;
&#xD;
         13. Use of hydralazine, procainamide, quinidine, isoniazide, TNF-inhibitors, minocycline&#xD;
             within the last 12 months prior to screening.&#xD;
&#xD;
         14. Use of diltiazem unless on a stable dose for at least 3 months prior to screening.&#xD;
&#xD;
         15. Significant risk of suicide defined, using the Columbia-Suicide Severity Rating Scale,&#xD;
             as the subject answering: &quot;yes&quot; to suicidal ideation questions 4 or 5 or answering:&#xD;
             &quot;yes&quot; to suicidal behavior within the past 12 months.&#xD;
&#xD;
         16. Concomitant psychiatric or neurologic disorder other than those considered to be&#xD;
             related to AD.&#xD;
&#xD;
         17. History or presence of uncontrolled seizures.&#xD;
&#xD;
         18. History of meningoencephalitis within the past 10 years prior to screening.&#xD;
&#xD;
         19. Subjects with a history of hemorrhagic and/or non-hemorrhagic stroke.&#xD;
&#xD;
         20. Presence or history of peripheral neuropathy.&#xD;
&#xD;
         21. History of inflammatory neurological disorders with potential for CNS involvement.&#xD;
&#xD;
         22. Screening MRI scan showing structural evidence of alternative pathology not consistent&#xD;
             with AD which could cause the subject's symptoms.&#xD;
&#xD;
         23. MRI examination cannot be done for any reason, including but not limited to metal&#xD;
             implants contraindicated for MRI studies and/or severe claustrophobia.&#xD;
&#xD;
         24. Significant hearing or visual impairment or other issues judged relevant by the&#xD;
             investigator preventing to comply with the protocol and to perform the outcome&#xD;
             measures.&#xD;
&#xD;
         25. Clinically significant infections or major surgical operation within 3 months prior to&#xD;
             screening.&#xD;
&#xD;
         26. Any vaccine received within the past 2 weeks before screening, including influenza&#xD;
             vaccine.&#xD;
&#xD;
         27. Clinically significant arrhythmias or other clinically significant abnormalities on&#xD;
             ECG at screening.&#xD;
&#xD;
         28. Myocardial infarction within one year prior to baseline, unstable angina pectoris, or&#xD;
             significant coronary artery disease.&#xD;
&#xD;
         29. History of cancer within the past 5 years other than treated squamous cell carcinoma,&#xD;
             basal cell carcinoma and melanoma in situ, or in-situ prostate cancer or in-situ&#xD;
             breast cancer which have been fully removed and are considered cured.&#xD;
&#xD;
         30. Clinically significant deviations from normal values for hematologic parameters, liver&#xD;
             function tests, and other biochemical measures, that are judged to be clinically&#xD;
             significant in the opinion of the investigator.&#xD;
&#xD;
         31. Pregnancy confirmed by blood test at screening, or subject planning to be pregnant or&#xD;
             lactating.&#xD;
&#xD;
         32. Receipt of any anticoagulant drug or antiplatelet drug, except aspirin at doses of 100&#xD;
             mg daily or lower.&#xD;
&#xD;
         33. Receipt of any antipsychotic drugs unless on stable low doses for the treatment of&#xD;
             insomnia.&#xD;
&#xD;
         34. Donation of blood or blood products within 30 days prior to screening or plans to&#xD;
             donate blood while participating in the study.&#xD;
&#xD;
         35. Positive Venereal Disease Research Laboratory (VDRL) consistent with active syphilis&#xD;
             at screening.&#xD;
&#xD;
         36. Positive HIV test at screening.&#xD;
&#xD;
         37. Laboratory or clinical evidence of active hepatitis B and/or C at screening.&#xD;
&#xD;
         38. Serum creatinine greater than 1.5x upper limit of normal, abnormal thyroid function&#xD;
             tests or clinically significant reduction in serum B12 or folate levels.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Philip Scheltens, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Amsterdam UMC Alzheimer Center de Boelelaan Amsterdam The Netherlands</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Clinical Research Services Helsinki</name>
      <address>
        <city>Helsinki</city>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Itä-Suomen Yliopisto - Kuopion Kampus</name>
      <address>
        <city>Kuopio</city>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Services Turku</name>
      <address>
        <city>Turku</city>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Brain Research Center - Den Bosch</name>
      <address>
        <city>'s-Hertogenbosch</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Brain Research Center - Amsterdam</name>
      <address>
        <city>Amsterdam</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Minnesmottagningen - Sahlgrenska Universitetssjukhuset - Mölndal Sjukhus</name>
      <address>
        <city>Mölndal</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kognitiv Mottagning - Karolinska Universitetssjukhuset - Huddinge</name>
      <address>
        <city>Stockholm</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Edinburgh Clinical Research Facility</name>
      <address>
        <city>Edinburgh</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University College London Hospitals NHS Foundation Trust</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Finland</country>
    <country>Netherlands</country>
    <country>Sweden</country>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>June 22, 2020</study_first_submitted>
  <study_first_submitted_qc>June 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 24, 2020</study_first_posted>
  <last_update_submitted>July 21, 2023</last_update_submitted>
  <last_update_submitted_qc>July 21, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 24, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Alzheimer's Disease</keyword>
  <keyword>Cognitive Impairment</keyword>
  <keyword>Tauopathies</keyword>
  <keyword>Mild Cognitive Impairment</keyword>
  <keyword>Dementia</keyword>
  <keyword>Brain Diseases</keyword>
  <keyword>Central Nervous System Diseases</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alzheimer Disease</mesh_term>
    <mesh_term>Dementia</mesh_term>
    <mesh_term>Nervous System Diseases</mesh_term>
    <mesh_term>Brain Diseases</mesh_term>
    <mesh_term>Central Nervous System Diseases</mesh_term>
    <mesh_term>Tauopathies</mesh_term>
    <mesh_term>Cognitive Dysfunction</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </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/NCT04445831
org study id: ACI-35-1802
secondary id: 2018-004573-27
nct id: NCT04445831
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study is a multicenter, double blind, randomized, placebo-controlled study to evaluate
      the safety, tolerability and immunogenicity of different doses, regimens and combinations of
      Tau targeted vaccines in participants with early Alzheimer's Disease.
allocation: Randomized
intervention model: Sequential Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Number of participants with Adverse Events (AEs) assessed by intensity (mild, moderate or severe) and causal relationship (unrelated, unlikely, possibly or probably related)
time frame: from screening up to week 74
measure: Change from baseline in anti-phosphorylated Tau IgG titers in blood
time frame: from baseline up to week 74
measure: Mean change from baseline in systolic and diastolic blood pressure (mmHg)
time frame: from baseline up to week 74
measure: Mean change from baseline in heart rate (bpm)
time frame: from baseline up to week 74
measure: Mean change from baseline in body temperature (degree Celsius)
time frame: from baseline up to week 74
measure: Number of participants reporting suicidal ideation or behavior using Columbia-Suicide Severity Rating Scale (C-SSRS)
time frame: from baseline up to week 74
measure: Number of participants with abnormal MRI results
time frame: from baseline up to week 74
measure: Change from baseline in anti-Tau IgG titers in blood
time frame: from baseline up to week 74
measure: Change from baseline in anti-phosphorylated Tau IgM titers in blood
time frame: from baseline up to week 74
measure: Change from baseline in anti-Tau IgM titers in blood
time frame: from baseline up to week 74
measure: Change from baseline of functional performance using Clinical Dementia Rating scale Sum of Boxes (CDR-SB)
time frame: from baseline up to week 74
description: The score ranges from 0 to 18. A higher score indicates a worse outcome.
measure: Change from baseline of cognitive performance using Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
time frame: from baseline up to week 74
description: The total scale index score ranges from 40 to 160. A higher score indicates a better outcome.
measure: Change from baseline of behavior using Neuropsychiatric Inventory Scale (NPI)
time frame: from baseline up to week 74
description: The score ranges from 0 to 144. A higher score indicates a worse outcome.
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo administered at predefined time points over a 48-week period.
arm group label: ACI-35.030 - Low dose
arm group type: Experimental
description: Active vaccine administered at predefined time points over a 48-week period.
arm group label: ACI-35.030 - Medium dose
arm group type: Experimental
description: Active vaccine administered at predefined time points over a 48-week period.
arm group label: ACI-35.030 - High dose
arm group type: Experimental
description: Active vaccine administered at predefined time points over a 48-week period.
arm group label: JACI-35.054 - Low dose
arm group type: Experimental
description: Active vaccine administered at predefined time points over a 48-week period.
arm group label: JACI-35.054 - Medium dose
arm group type: Experimental
description: Active vaccine administered at predefined time points over a 48-week period.
intervention type: Biological
intervention name: ACI-35.030
description: Administration of a Low dose of ACI-35.030
arm group label: ACI-35.030 - Low dose
intervention type: Biological
intervention name: ACI-35.030
description: Administration of a Medium dose of ACI-35.030
arm group label: ACI-35.030 - Medium dose
intervention type: Biological
intervention name: ACI-35.030
description: Administration of a High dose of ACI-35.030
arm group label: ACI-35.030 - High dose
intervention type: Other
intervention name: Placebo
description: Administration of Placebo
arm group label: Placebo
intervention type: Biological
intervention name: JACI-35.054
description: Administration of a Low dose of JACI-35.054
arm group label: JACI-35.054 - Low dose
intervention type: Biological
intervention name: JACI-35.054
description: Administration of a Medium dose of JACI-35.054
arm group label: JACI-35.054 - Medium dose
criteria: 
gender: All
minimum age: 50 Years
maximum age: 75 Years
healthy volunteers: No
last name: Philip Scheltens, MD
role: Principal Investigator
affiliation: Amsterdam UMC Alzheimer Center de Boelelaan Amsterdam The Netherlands
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Finland
country: Netherlands
country: Sweden
country: United Kingdom
responsible party type: Sponsor
mesh term: Alzheimer Disease
mesh term: Dementia
mesh term: Nervous System Diseases
mesh term: Brain Diseases
mesh term: Central Nervous System Diseases
mesh term: Tauopathies
mesh term: Cognitive Dysfunction
sharing ipd: Undecided