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Tetra PICASSO AD Trial: Study to Evaluate Effects of BPN14770 in Early Alzheimer's Subjects

Sponsor
Tetra Discovery Partners (Industry)
Overall Status
Unknown status
CT.gov ID
NCT03817684
Collaborator
(none)
255
Enrollment
41
Locations
3
Arms
9.1
Anticipated Duration (Months)
6.2
Patients Per Site
0.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

A Randomized, Double-blind, Placebo Controlled, 3-Arm Parallel Design Study to Evaluate the Effects of BPN14770 in Patients with Early Alzheimer's Disease

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
255 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Apr 30, 2019
Anticipated Primary Completion Date :
Feb 1, 2020
Anticipated Study Completion Date :
Feb 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: BPN14770 10mg bid

10 mg bid dose of the Drug BPN14770

Drug: BPN14770
Drug BPN14770
Experimental: BPN 14770 25mg bid

25mg bid dose of the Drug BPN14770

Drug: BPN14770
Drug BPN14770
Placebo Comparator: Placebo

Drug: Placebo
Placebo

Outcome Measures

Primary Outcome Measures

  1. Repeatable Battery for the Assessment of Neurological Status- Delayed Memory Index (RBANS- DMI) [Week 13]

    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

Secondary Outcome Measures

  1. Repeatable Battery for the Assessment of Neurological Status (RBANS) total score [Weeks 1,2,4,8,13]

    Comparison of RBANs Total scores to baseline at each timepoint

  2. Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL) [Week 8, 13]

    ADCS-ADL total score compared to baseline at each time point

  3. Mini-Mental State Exam (MMSE) Score [Weeks 1,2,4,8,13]

    MMSE total score versus baseline at each timepoint

  4. Clinical Dementia Rating Sum of Boxes Score (CDR-SB) [Week 13]

    CDR-SB versus Baseline at each timepoint

  5. Clinical Global Impression - Improvement (CGI-I) Score [Week 1,2,4,8,13]

    CGI-I Score versus Baseline at each timepoint

  6. Pharmacokinetics: Maximum Drug Plasma Levels [Weeks 1,4,8,13]

    Maximum Drug plasma concentration levels by study arm

Eligibility Criteria

Criteria

Ages Eligible for Study:
55 Years to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  1. Males or females between the ages of 55 and 85 years with a clinical diagnosis of early stage AD, defined according to the following criteria assessed during Screening and at Baseline :

  2. Clinical Dementia Rating (CDR) score of 0.5 or 1, with Memory Box score of 0.5 or greater

  3. MMSE score of 20 or greater

  4. RBANS DMI score ≤ 85 Note: PET imaging for amyloid is not required for diagnosis, which will be made on clinical grounds.

  5. Currently receiving a stable (at least 2 months) dose regimen of donepezil or another cholinesterase inhibitor for treatment of Alzheimer's disease. Doses of these drugs may not be changed during the trial.

Note: Memantine is not permitted during the trial and must be discontinued at least 3 weeks prior to Baseline.

  1. Modified Hachinski Ischemia score < 4.

  2. Body mass index (BMI) < 38 kg/m2, inclusive, and body weight of >48 kg (105 pounds) at screening.

  3. Female subjects must be at least two years post-menopausal (subjected reported menopausal status), surgically sterile (bilateral tubal ligation, hysterectomy, or bilateral oophorectomy at least 6 months prior to first study drug administration), or willing to either (1) utilize hormonal contraception plus one barrier method or (2) use two barrier methods of contraception (e.g. diaphragm and spermicide) from initial screening until one month after taking the final dose. An intrauterine device (IUD) is considered a barrier method of contraception in this study. Male subjects must be willing to inform female partners of their participation in the study and must agree to use adequate contraceptive methods (vasectomy performed at least 6 months prior to first study drug administration, or use at least one barrier method of birth control).

  4. Able to understand and comply with the study procedures, voluntarily agree to participate in this study, and provide written informed consent prior to start of any study-specific procedures.

  5. All subjects must have a caregiver who is willing and able to ensure compliance with study medications, visits, and study procedures.

Exclusion Criteria:

  1. Any medical or neurological condition (other than early stage AD) that might be a contributing cause to the subject's cognitive impairment.

  2. History of stroke or multiple (>3 discreet episodes) Transient Ischemic Attacks (TIAs), severe head trauma with cognitive sequelae, uncontrolled seizures, or unexplained prolonged loss of consciousness (> 1 minute) during the past year.

  3. Clinically significant major psychiatric illness during the past 6 months.

  4. History of unstable angina, myocardial infarction, chronic heart failure, or clinically significant conduction abnormalities during the past year.

  5. Clinically significant liver or renal disease.

  6. Clinically significant abnormality, in the Investigator's judgment, in hematology, chemistry, or urinalysis.

  7. Positive serology results for hepatitis B surface antigen (HbsAg) or hepatitis C virus (HCV).

  8. Abnormal liver function test at the Screening Visit (aspartate aminotransferase or alanine aminotransferase >2

× the upper limit of normal [ULN], or total bilirubin >1.7 × ULN, based on appropriate age and gender normal values). Subjects may be re-screened once.

  1. Marked hypotension (systolic blood pressure [BP] ˂90 mmHg or diastolic BP ˂50 mmHg) or hypertension (systolic BP ˃160 mmHg or diastolic BP ˃100 mmHg) based on sitting values. O ut-of-range results may be repeated once at Screening, and eligibility must be confirmed at Baseline.

  2. Marked bradycardia (heart rate ˂45 beats per minute [bpm]) or tachycardia (heart rate ˃115 bpm) based on supine ECG values. Out-of-range results may be repeated once at Screening, and eligibility must be confirmed at Baseline.

  3. Clinically important conduction abnormalities on ECG, or evidence or history of long QT syndrome based on supine ECG values obtained at Screening. Out-of-range results may be repeated once and eligibility confirmed at Baseline.

  4. Active gastric or duodenal ulcers or other diseases of the gastrointestinal tract that could interfere with absorption of study drug. Note: Subjects with a history of appendectomy or cholecystectomy may be enrolled.

  5. Active acute or chronic infectious diseases that would interfere with subject's participation in the study.

  6. Unable to discontinue centrally active medications (other than cholinesterase inhibitors), including memantine, psychotropic drugs other than SSRIs (which must have been stable for 2 months and remain stable throughout the study), sedative antihistamines or other centrally active medications with potential cognitive effects (e.g., CNS-penetrant beta blockers).

  7. Unable to discontinue moderate to strong inhibitors or inducers of CYP3A4, CYP2D6, or other cytochromes at least 14 days prior to the first dose of study drug. A complete listing of such inhibitors or inducers may be found in http://medicine.iupui.edu/clinpharm/ddis/main-table (Other prescription or non-prescription drugs such as antihypertensive or cholesterol lowering agents are allowed, if, in the Investigator's judgement, they would not interfere with the study medication or the cognitive testing.)

  8. A suicidal ideation intensity score of 3 or higher per screening Columbia Suicide Severity Rating Scale (CSSRS) assessment on Day 1 (Baseline) and/or any suicidal behavior within the past 28 days.

  9. History of chronic alcohol or other substance abuse, including marijuana, within the previous year prior to the Screening visit (per the current edition of the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition: DSM-5), or regular (daily) consumption of alcohol exceeding two bottles of beer, or the equivalent amount of other forms of alcohol (1 serving = 12 oz beer, 5.0 oz wine, or 1.5 oz distilled spirits).

  10. Inability or unwillingness to comply with the protocol, including performing the cognitive function tests, or likely inability to complete the study.

  11. Participation in other clinical studies involving investigational drug within the previous 30 days prior to the Screening Visit.

  12. Donation of blood within 4 weeks, or blood products within 2 weeks, prior to first study drug administration.

  13. History of clinically significant drug allergy that includes symptoms such as shortness of breath, rash, or edema.

  14. Clinically significant B12 deficiency within 12 months prior to Visit 1 (Screening). Participants on stable replacement therapy for a minimum of 3 consecutive months immediately prior to Visit 1 (Screening) may be included

Contacts and Locations

Locations

Site City State Country Postal Code
1 Generations at Agritopia/CCT Research Gilbert Arizona United States 85296
2 CiTrials, Inc. Bellflower California United States 90709
3 ATP Clinical Research, Inc Costa Mesa California United States 92626
4 Alliance for Research Long Beach California United States 90807
5 Pacific Research Network Inc. San Diego California United States 92103
6 HB Clinical Trials, Inc. Santa Ana California United States 92704
7 Mile High Research Center Denver Colorado United States 80218
8 JEM Research Insitute Atlantis Florida United States 33462
9 Linfritz Research Group Coral Gables Florida United States 33134
10 Brain Matters Research Delray Beach Florida United States 33445
11 MD Clinical Hallandale Beach Florida United States 33009
12 Galiz Research Hialeah Florida United States 33016
13 Alzheimer's Research and Treatement Center Lake Worth Florida United States 33449
14 Optimus Clinical Research Miami Florida United States 33125
15 BioMed Research Institute Miami Florida United States 33126
16 Finlay Medical Research Miami Florida United States 33126
17 Pharmax Research Clinic Miami Florida United States 33126
18 Vitae Research Center, LLC Miami Florida United States 33135
19 Arocha Research Center Miami Florida United States 33145
20 Allied Biomedical Research Institute Inc. Miami Florida United States 33155
21 Advanced Clinical Research Network Miami Florida United States 33176
22 Gutierrez Medical Center LLD Orlando Florida United States 32807
23 Neurology Associates of Ormond Beach Ormond Beach Florida United States 32174
24 Palm Beach Neurological Center Palm Beach Florida United States 33410
25 IMIC Inc Palmetto Bay Florida United States 33157
26 Synergy Clinical Research Pensacola Florida United States 32514
27 Quantum Laboratories Pompano Beach Florida United States 33064
28 Neurosciences Research Elk Grove Village Illinois United States 60007
29 Hassman Research Institute Berlin New Jersey United States 08009
30 Advanced Memory Research Institute of NJ PC Toms River New Jersey United States 08755
31 Integrative Clinical Trials Brooklyn New York United States 11229
32 Neurological Associates of Long Island Lake Success New York United States 11042
33 Manhattan Behavioral Medicine PLLC New York New York United States 10036
34 Alzheimers Memory Center Charlotte North Carolina United States 28270
35 Neurology Diagnostics, Inc. Dayton Ohio United States 45459
36 MDH Research Westerville Ohio United States 43081
37 Summit Research Network Portland Oregon United States 97210
38 Lehigh Center for Clinical Research Allentown Pennsylvania United States 18104
39 Neurology Clinic, P.C. Cordova Tennessee United States 38018
40 Aspen Clinical Research Orem Utah United States 84058
41 Wasatch Clinical Research, LLC Salt Lake City Utah United States 84107

Sponsors and Collaborators

  • Tetra Discovery Partners

Investigators

  • Study Director: Scott Reines, MD, Tetra Discovery Partners

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Tetra Discovery Partners
ClinicalTrials.gov Identifier:
NCT03817684
Other Study ID Numbers:
  • BPN14770-CNS-201
First Posted:
Jan 25, 2019
Last Update Posted:
Oct 31, 2019
Last Verified:
Oct 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Alzheimer Disease

Study Results

No Results Posted as of Oct 31, 2019