<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/NCT03817684</url>
  </required_header>
  <id_info>
    <org_study_id>BPN14770-CNS-201</org_study_id>
    <nct_id>NCT03817684</nct_id>
  </id_info>
  <brief_title>Tetra PICASSO AD Trial: Study to Evaluate Effects of BPN14770 in Early Alzheimer's Subjects</brief_title>
  <official_title>A Randomized , Double Blind, Placebo Controlled, 3-Arm Parallel Design Study to Evaluate the Effects of BPN14770 in Patients With Early Stage Alzheimer's Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tetra Discovery Partners</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tetra Discovery Partners</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>
      A Randomized, Double-blind, Placebo Controlled, 3-Arm Parallel Design Study to Evaluate the&#xD;
      Effects of BPN14770 in Patients with Early Alzheimer's Disease&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">April 30, 2019</start_date>
  <completion_date type="Anticipated">February 2020</completion_date>
  <primary_completion_date type="Anticipated">February 2020</primary_completion_date>
  <phase>Phase 2</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>Repeatable Battery for the Assessment of Neurological Status- Delayed Memory Index (RBANS- DMI)</measure>
    <time_frame>Week 13</time_frame>
    <description>Change from baseline of RBANS-DMI score. Power based on true difference of 7.15 units on normalized mean of score of 100 between 25mg dose Arm vs Placebo</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Repeatable Battery for the Assessment of Neurological Status (RBANS) total score</measure>
    <time_frame>Weeks 1,2,4,8,13</time_frame>
    <description>Comparison of RBANs Total scores to baseline at each timepoint</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL)</measure>
    <time_frame>Week 8, 13</time_frame>
    <description>ADCS-ADL total score compared to baseline at each time point</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mini-Mental State Exam (MMSE) Score</measure>
    <time_frame>Weeks 1,2,4,8,13</time_frame>
    <description>MMSE total score versus baseline at each timepoint</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical Dementia Rating Sum of Boxes Score (CDR-SB)</measure>
    <time_frame>Week 13</time_frame>
    <description>CDR-SB versus Baseline at each timepoint</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical Global Impression - Improvement (CGI-I) Score</measure>
    <time_frame>Week 1,2,4,8,13</time_frame>
    <description>CGI-I Score versus Baseline at each timepoint</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics: Maximum Drug Plasma Levels</measure>
    <time_frame>Weeks 1,4,8,13</time_frame>
    <description>Maximum Drug plasma concentration levels by study arm</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">255</enrollment>
  <condition>Alzheimer's Disease</condition>
  <arm_group>
    <arm_group_label>BPN14770 10mg bid</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>10 mg bid dose of the Drug BPN14770</description>
  </arm_group>
  <arm_group>
    <arm_group_label>BPN 14770 25mg bid</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>25mg bid dose of the Drug BPN14770</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BPN14770</intervention_name>
    <description>Drug BPN14770</description>
    <arm_group_label>BPN 14770 25mg bid</arm_group_label>
    <arm_group_label>BPN14770 10mg bid</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Males or females between the ages of 55 and 85 years with a clinical diagnosis of&#xD;
             early stage AD, defined according to the following criteria assessed during Screening&#xD;
             and at Baseline :&#xD;
&#xD;
               1. Clinical Dementia Rating (CDR) score of 0.5 or 1, with Memory Box score of 0.5 or&#xD;
                  greater&#xD;
&#xD;
               2. MMSE score of 20 or greater&#xD;
&#xD;
               3. RBANS DMI score ≤ 85 Note: PET imaging for amyloid is not required for diagnosis,&#xD;
                  which will be made on clinical grounds.&#xD;
&#xD;
          2. Currently receiving a stable (at least 2 months) dose regimen of donepezil or another&#xD;
             cholinesterase inhibitor for treatment of Alzheimer's disease. Doses of these drugs&#xD;
             may not be changed during the trial.&#xD;
&#xD;
             Note: Memantine is not permitted during the trial and must be discontinued at least 3&#xD;
             weeks prior to Baseline.&#xD;
&#xD;
          3. Modified Hachinski Ischemia score &lt; 4.&#xD;
&#xD;
          4. Body mass index (BMI) &lt; 38 kg/m2, inclusive, and body weight of &gt;48 kg (105 pounds) at&#xD;
             screening.&#xD;
&#xD;
          5. Female subjects must be at least two years post-menopausal (subjected reported&#xD;
             menopausal status), surgically sterile (bilateral tubal ligation, hysterectomy, or&#xD;
             bilateral oophorectomy at least 6 months prior to first study drug administration), or&#xD;
             willing to either (1) utilize hormonal contraception plus one barrier method or (2)&#xD;
             use two barrier methods of contraception (e.g. diaphragm and spermicide) from initial&#xD;
             screening until one month after taking the final dose. An intrauterine device (IUD) is&#xD;
             considered a barrier method of contraception in this study. Male subjects must be&#xD;
             willing to inform female partners of their participation in the study and must agree&#xD;
             to use adequate contraceptive methods (vasectomy performed at least 6 months prior to&#xD;
             first study drug administration, or use at least one barrier method of birth control).&#xD;
&#xD;
          6. Able to understand and comply with the study procedures, voluntarily agree to&#xD;
             participate in this study, and provide written informed consent prior to start of any&#xD;
             study-specific procedures.&#xD;
&#xD;
          7. All subjects must have a caregiver who is willing and able to ensure compliance with&#xD;
             study medications, visits, and study procedures.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Any medical or neurological condition (other than early stage AD) that might be a&#xD;
             contributing cause to the subject's cognitive impairment.&#xD;
&#xD;
          2. History of stroke or multiple (&gt;3 discreet episodes) Transient Ischemic Attacks&#xD;
             (TIAs), severe head trauma with cognitive sequelae, uncontrolled seizures, or&#xD;
             unexplained prolonged loss of consciousness (&gt; 1 minute) during the past year.&#xD;
&#xD;
          3. Clinically significant major psychiatric illness during the past 6 months.&#xD;
&#xD;
          4. History of unstable angina, myocardial infarction, chronic heart failure, or&#xD;
             clinically significant conduction abnormalities during the past year.&#xD;
&#xD;
          5. Clinically significant liver or renal disease.&#xD;
&#xD;
          6. Clinically significant abnormality, in the Investigator's judgment, in hematology,&#xD;
             chemistry, or urinalysis.&#xD;
&#xD;
          7. Positive serology results for hepatitis B surface antigen (HbsAg) or hepatitis C virus&#xD;
             (HCV).&#xD;
&#xD;
          8. Abnormal liver function test at the Screening Visit (aspartate aminotransferase or&#xD;
             alanine aminotransferase &gt;2&#xD;
&#xD;
             × the upper limit of normal [ULN], or total bilirubin &gt;1.7 × ULN, based on appropriate&#xD;
             age and gender normal values). Subjects may be re-screened once.&#xD;
&#xD;
          9. Marked hypotension (systolic blood pressure [BP] ˂90 mmHg or diastolic BP ˂50 mmHg) or&#xD;
             hypertension (systolic BP ˃160 mmHg or diastolic BP ˃100 mmHg) based on sitting&#xD;
             values. O ut-of-range results may be repeated once at Screening, and eligibility must&#xD;
             be confirmed at Baseline.&#xD;
&#xD;
         10. Marked bradycardia (heart rate ˂45 beats per minute [bpm]) or tachycardia (heart rate&#xD;
             ˃115 bpm) based on supine ECG values. Out-of-range results may be repeated once at&#xD;
             Screening, and eligibility must be confirmed at Baseline.&#xD;
&#xD;
         11. Clinically important conduction abnormalities on ECG, or evidence or history of long&#xD;
             QT syndrome based on supine ECG values obtained at Screening. Out-of-range results may&#xD;
             be repeated once and eligibility confirmed at Baseline.&#xD;
&#xD;
         12. Active gastric or duodenal ulcers or other diseases of the gastrointestinal tract that&#xD;
             could interfere with absorption of study drug. Note: Subjects with a history of&#xD;
             appendectomy or cholecystectomy may be enrolled.&#xD;
&#xD;
         13. Active acute or chronic infectious diseases that would interfere with subject's&#xD;
             participation in the study.&#xD;
&#xD;
         14. Unable to discontinue centrally active medications (other than cholinesterase&#xD;
             inhibitors), including memantine, psychotropic drugs other than SSRIs (which must have&#xD;
             been stable for 2 months and remain stable throughout the study), sedative&#xD;
             antihistamines or other centrally active medications with potential cognitive effects&#xD;
             (e.g., CNS-penetrant beta blockers).&#xD;
&#xD;
         15. Unable to discontinue moderate to strong inhibitors or inducers of CYP3A4, CYP2D6, or&#xD;
             other cytochromes at least 14 days prior to the first dose of study drug. A complete&#xD;
             listing of such inhibitors or inducers may be found in&#xD;
             http://medicine.iupui.edu/clinpharm/ddis/main-table (Other prescription or&#xD;
             non-prescription drugs such as antihypertensive or cholesterol lowering agents are&#xD;
             allowed, if, in the Investigator's judgement, they would not interfere with the study&#xD;
             medication or the cognitive testing.)&#xD;
&#xD;
         16. A suicidal ideation intensity score of 3 or higher per screening Columbia Suicide&#xD;
             Severity Rating Scale (CSSRS) assessment on Day 1 (Baseline) and/or any suicidal&#xD;
             behavior within the past 28 days.&#xD;
&#xD;
         17. History of chronic alcohol or other substance abuse, including marijuana, within the&#xD;
             previous year prior to the Screening visit (per the current edition of the Diagnostic&#xD;
             and Statistical Manual of Mental Disorders, 5th Edition: DSM-5), or regular (daily)&#xD;
             consumption of alcohol exceeding two bottles of beer, or the equivalent amount of&#xD;
             other forms of alcohol (1 serving = 12 oz beer, 5.0 oz wine, or 1.5 oz distilled&#xD;
             spirits).&#xD;
&#xD;
         18. Inability or unwillingness to comply with the protocol, including performing the&#xD;
             cognitive function tests, or likely inability to complete the study.&#xD;
&#xD;
         19. Participation in other clinical studies involving investigational drug within the&#xD;
             previous 30 days prior to the Screening Visit.&#xD;
&#xD;
         20. Donation of blood within 4 weeks, or blood products within 2 weeks, prior to first&#xD;
             study drug administration.&#xD;
&#xD;
         21. History of clinically significant drug allergy that includes symptoms such as&#xD;
             shortness of breath, rash, or edema.&#xD;
&#xD;
         22. Clinically significant B12 deficiency within 12 months prior to Visit 1 (Screening).&#xD;
             Participants on stable replacement therapy for a minimum of 3 consecutive months&#xD;
             immediately prior to Visit 1 (Screening) may be included&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>55 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Scott Reines, MD</last_name>
    <role>Study Director</role>
    <affiliation>Tetra Discovery Partners</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Generations at Agritopia/CCT Research</name>
      <address>
        <city>Gilbert</city>
        <state>Arizona</state>
        <zip>85296</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CiTrials, Inc.</name>
      <address>
        <city>Bellflower</city>
        <state>California</state>
        <zip>90709</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ATP Clinical Research, Inc</name>
      <address>
        <city>Costa Mesa</city>
        <state>California</state>
        <zip>92626</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alliance for Research</name>
      <address>
        <city>Long Beach</city>
        <state>California</state>
        <zip>90807</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pacific Research Network Inc.</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HB Clinical Trials, Inc.</name>
      <address>
        <city>Santa Ana</city>
        <state>California</state>
        <zip>92704</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mile High Research Center</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80218</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>JEM Research Insitute</name>
      <address>
        <city>Atlantis</city>
        <state>Florida</state>
        <zip>33462</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Linfritz Research Group</name>
      <address>
        <city>Coral Gables</city>
        <state>Florida</state>
        <zip>33134</zip>
        <country>United States</country>
      </address>
    </facility>
  </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>
  </location>
  <location>
    <facility>
      <name>MD Clinical</name>
      <address>
        <city>Hallandale Beach</city>
        <state>Florida</state>
        <zip>33009</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galiz Research</name>
      <address>
        <city>Hialeah</city>
        <state>Florida</state>
        <zip>33016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alzheimer's Research and Treatement Center</name>
      <address>
        <city>Lake Worth</city>
        <state>Florida</state>
        <zip>33449</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Optimus Clinical Research</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33125</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>BioMed Research Institute</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33126</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Finlay Medical Research</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33126</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pharmax Research Clinic</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33126</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vitae Research Center, LLC</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33135</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arocha Research Center</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33145</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Allied Biomedical Research Institute Inc.</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33155</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Advanced Clinical Research Network</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33176</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gutierrez Medical Center LLD</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32807</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Neurology Associates of Ormond Beach</name>
      <address>
        <city>Ormond Beach</city>
        <state>Florida</state>
        <zip>32174</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Palm Beach Neurological Center</name>
      <address>
        <city>Palm Beach</city>
        <state>Florida</state>
        <zip>33410</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IMIC Inc</name>
      <address>
        <city>Palmetto Bay</city>
        <state>Florida</state>
        <zip>33157</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Synergy Clinical Research</name>
      <address>
        <city>Pensacola</city>
        <state>Florida</state>
        <zip>32514</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Quantum Laboratories</name>
      <address>
        <city>Pompano Beach</city>
        <state>Florida</state>
        <zip>33064</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Neurosciences Research</name>
      <address>
        <city>Elk Grove Village</city>
        <state>Illinois</state>
        <zip>60007</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hassman Research Institute</name>
      <address>
        <city>Berlin</city>
        <state>New Jersey</state>
        <zip>08009</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Advanced Memory Research Institute of NJ PC</name>
      <address>
        <city>Toms River</city>
        <state>New Jersey</state>
        <zip>08755</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Integrative Clinical Trials</name>
      <address>
        <city>Brooklyn</city>
        <state>New York</state>
        <zip>11229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Neurological Associates of Long Island</name>
      <address>
        <city>Lake Success</city>
        <state>New York</state>
        <zip>11042</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Manhattan Behavioral Medicine PLLC</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10036</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alzheimers Memory Center</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28270</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Neurology Diagnostics, Inc.</name>
      <address>
        <city>Dayton</city>
        <state>Ohio</state>
        <zip>45459</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MDH Research</name>
      <address>
        <city>Westerville</city>
        <state>Ohio</state>
        <zip>43081</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Summit Research Network</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lehigh Center for Clinical Research</name>
      <address>
        <city>Allentown</city>
        <state>Pennsylvania</state>
        <zip>18104</zip>
        <country>United States</country>
      </address>
    </facility>
  </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>
  </location>
  <location>
    <facility>
      <name>Aspen Clinical Research</name>
      <address>
        <city>Orem</city>
        <state>Utah</state>
        <zip>84058</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wasatch Clinical Research, LLC</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>January 18, 2019</study_first_submitted>
  <study_first_submitted_qc>January 23, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 25, 2019</study_first_posted>
  <last_update_submitted>October 30, 2019</last_update_submitted>
  <last_update_submitted_qc>October 30, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 31, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alzheimer Disease</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>BPN14770</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>June 7, 2023</submitted>
    <returned>June 28, 2023</returned>
  </pending_results>
  <!-- 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/NCT03817684
org study id: BPN14770-CNS-201
nct id: NCT03817684
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
A Randomized, Double-blind, Placebo Controlled, 3-Arm Parallel Design Study to Evaluate the
      Effects of BPN14770 in Patients with Early Alzheimer's Disease
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Repeatable Battery for the Assessment of Neurological Status- Delayed Memory Index (RBANS- DMI)
time frame: Week 13
description: Change from baseline of RBANS-DMI score. Power based on true difference of 7.15 units on normalized mean of score of 100 between 25mg dose Arm vs Placebo
measure: Repeatable Battery for the Assessment of Neurological Status (RBANS) total score
time frame: Weeks 1,2,4,8,13
description: Comparison of RBANs Total scores to baseline at each timepoint
measure: Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL)
time frame: Week 8, 13
description: ADCS-ADL total score compared to baseline at each time point
measure: Mini-Mental State Exam (MMSE) Score
time frame: Weeks 1,2,4,8,13
description: MMSE total score versus baseline at each timepoint
measure: Clinical Dementia Rating Sum of Boxes Score (CDR-SB)
time frame: Week 13
description: CDR-SB versus Baseline at each timepoint
measure: Clinical Global Impression - Improvement (CGI-I) Score
time frame: Week 1,2,4,8,13
description: CGI-I Score versus Baseline at each timepoint
measure: Pharmacokinetics: Maximum Drug Plasma Levels
time frame: Weeks 1,4,8,13
description: Maximum Drug plasma concentration levels by study arm
arm group label: BPN14770 10mg bid
arm group type: Experimental
description: 10 mg bid dose of the Drug BPN14770
arm group label: BPN 14770 25mg bid
arm group type: Experimental
description: 25mg bid dose of the Drug BPN14770
arm group label: Placebo
arm group type: Placebo Comparator
intervention type: Drug
intervention name: BPN14770
description: Drug BPN14770
arm group label: BPN 14770 25mg bid
arm group label: BPN14770 10mg bid
intervention type: Drug
intervention name: Placebo
description: Placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 55 Years
maximum age: 85 Years
healthy volunteers: No
last name: Scott Reines, MD
role: Study Director
affiliation: Tetra Discovery Partners
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country: United States
responsible party type: Sponsor
mesh term: Alzheimer Disease
mesh term: BPN14770
sharing ipd: No
submitted: June 7, 2023
returned: June 28, 2023