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

NCT03817684 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: BPN14770-CNS-201
• Study Type: interventional
• Target: 255
• Locations: 1 country
• Sites: 41

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

Conditions

Alzheimer's Disease

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Repeatable Battery for the Assessment of Neurological Status- Delayed Memory Index (RBANS- DMI) at Week 13

  The RBANS is a brief, individually administered test measuring attention, language, visuospatial/constructional abilities, and immediate and delayed memory. It consists of 12 subtests, which yield 5 Index scores and a Total Scale score. Lower scores indicate worse performance on the test (and thus greater impairment). Scores for the RBANS DMI range from 40 (greater impairment) to 160 (improved function), with higher scores indicating improved function.

  Baseline, Week 13

Secondary Outcomes (5)

• Change From Baseline in Repeatable Battery for the Assessment of Neurological Status (RBANS) Total Score at Week 13

  Baseline, Week 13

• Change From Baseline in Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL) Total Score at Week 13

  Baseline, Week 13

• Change From Baseline in Mini-Mental State Exam (MMSE) Total Score at Week 13

  Baseline, Week 13

• Change From Baseline in Clinical Dementia Rating Sum of Boxes Score (CDR-SB) at Week 13

  Baseline, Week 13

• Clinical Global Impression - Improvement (CGI-I) Score

  Week 13

Study Arms (3)

BPN14770 10mg bid

EXPERIMENTAL

10 mg bid dose of the Drug BPN14770

Drug: BPN14770

BPN 14770 25mg bid

EXPERIMENTAL

25mg bid dose of the Drug BPN14770

Drug: BPN14770

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

BPN14770 DRUG

Drug BPN14770

BPN 14770 25mg bid; BPN14770 10mg bid

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 55 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 :
• Clinical Dementia Rating (CDR) score of 0.5 or 1, with Memory Box score of 0.5 or greater
• MMSE score of 20 or greater
• RBANS DMI score ≤ 85 Note: PET imaging for amyloid is not required for diagnosis, which will be made on clinical grounds.
• 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.
• Modified Hachinski Ischemia score \< 4.
• Body mass index (BMI) \< 38 kg/m2, inclusive, and body weight of \>48 kg (105 pounds) at screening.
• 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).
• 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.
• All subjects must have a caregiver who is willing and able to ensure compliance with study medications, visits, and study procedures.

You may not qualify if:

• Any medical or neurological condition (other than early stage AD) that might be a contributing cause to the subject's cognitive impairment.
• 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.
• Clinically significant major psychiatric illness during the past 6 months.
• History of unstable angina, myocardial infarction, chronic heart failure, or clinically significant conduction abnormalities during the past year.
• Clinically significant liver or renal disease.
• Clinically significant abnormality, in the Investigator's judgment, in hematology, chemistry, or urinalysis.
• Positive serology results for hepatitis B surface antigen (HbsAg) or hepatitis C virus (HCV).
• 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.
• 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.
• 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.
• 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.
• 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.
• Active acute or chronic infectious diseases that would interfere with subject's participation in the study.
• 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).

Sponsors & Collaborators

• Tetra Discovery Partners: lead

Study Sites (41)

Generations at Agritopia/CCT Research

Gilbert, Arizona, 85296, United States

Location

CiTrials, Inc.

Bellflower, California, 90709, United States

Location

ATP Clinical Research, Inc

Costa Mesa, California, 92626, United States

Location

Alliance for Research

Long Beach, California, 90807, United States

Location

Pacific Research Network Inc.

San Diego, California, 92103, United States

Location

HB Clinical Trials, Inc.

Santa Ana, California, 92704, United States

Location

Mile High Research Center

Denver, Colorado, 80218, United States

Location

JEM Research Insitute

Atlantis, Florida, 33462, United States

Location

Linfritz Research Group

Coral Gables, Florida, 33134, United States

Location

Brain Matters Research

Delray Beach, Florida, 33445, United States

Location

MD Clinical

Hallandale, Florida, 33009, United States

Location

Galiz Research

Hialeah, Florida, 33016, United States

Location

Alzheimer's Research and Treatement Center

Lake Worth, Florida, 33449, United States

Location

Optimus Clinical Research

Miami, Florida, 33125, United States

Location

BioMed Research Institute

Miami, Florida, 33126, United States

Location

Finlay Medical Research

Miami, Florida, 33126, United States

Location

Pharmax Research Clinic

Miami, Florida, 33126, United States

Location

Vitae Research Center, LLC

Miami, Florida, 33135, United States

Location

Arocha Research Center

Miami, Florida, 33145, United States

Location

Allied Biomedical Research Institute Inc.

Miami, Florida, 33155, United States

Location

Advanced Clinical Research Network

Miami, Florida, 33176, United States

Location

Gutierrez Medical Center LLD

Orlando, Florida, 32807, United States

Location

Neurology Associates of Ormond Beach

Ormond Beach, Florida, 32174, United States

Location

Palm Beach Neurological Center

Palm Beach, Florida, 33410, United States

Location

IMIC Inc

Palmetto Bay, Florida, 33157, United States

Location

Synergy Clinical Research

Pensacola, Florida, 32514, United States

Location

Quantum Laboratories

Pompano Beach, Florida, 33064, United States

Location

Neurosciences Research

Elk Grove Village, Illinois, 60007, United States

Location

Hassman Research Institute

Berlin, New Jersey, 08009, United States

Location

Advanced Memory Research Institute of NJ PC

Toms River, New Jersey, 08755, United States

Location

Integrative Clinical Trials

Brooklyn, New York, 11229, United States

Location

Neurological Associates of Long Island

Lake Success, New York, 11042, United States

Location

Manhattan Behavioral Medicine PLLC

New York, New York, 10036, United States

Location

Alzheimers Memory Center

Charlotte, North Carolina, 28270, United States

Location

Neurology Diagnostics, Inc.

Dayton, Ohio, 45459, United States

Location

MDH Research

Westerville, Ohio, 43081, United States

Location

Summit Research Network

Portland, Oregon, 97210, United States

Location

Lehigh Center for Clinical Research

Allentown, Pennsylvania, 18104, United States

Location

Neurology Clinic, P.C.

Cordova, Tennessee, 38018, United States

Location

Aspen Clinical Research

Orem, Utah, 84058, United States

Location

Wasatch Clinical Research, LLC

Salt Lake City, Utah, 84107, United States

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

BPN14770

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Results Point of Contact

• Title: CEO
• Organization: Tetra Therapeutics

info@tetratherapeutics.com

616-224-0084

Study Officials

• Scott Reines, MD

  Tetra Discovery Partners

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2019
• First Posted: January 25, 2019
• Study Start: April 30, 2019
• Primary Completion: February 4, 2020
• Study Completion: February 4, 2020
• Last Updated: February 18, 2025
• Results First Posted: February 18, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (41)