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

Who is this study for? Older adult patients with Alzheimer's Disease
What treatments are being studied? BPN14770
Status: Completed
Location: See all (41) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 55
Maximum Age: 85
Healthy Volunteers: f
View:

• 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.

Locations
United States
Arizona
Generations at Agritopia/CCT Research
Gilbert
California
CiTrials, Inc.
Bellflower
ATP Clinical Research, Inc
Costa Mesa
Alliance for Research
Long Beach
Pacific Research Network Inc.
San Diego
HB Clinical Trials, Inc.
Santa Ana
Colorado
Mile High Research Center
Denver
Florida
JEM Research Insitute
Atlantis
Linfritz Research Group
Coral Gables
Brain Matters Research
Delray Beach
MD Clinical
Hallandale Beach
Galiz Research
Hialeah
Alzheimer's Research and Treatement Center
Lake Worth
Advanced Clinical Research Network
Miami
Allied Biomedical Research Institute Inc.
Miami
Arocha Research Center
Miami
BioMed Research Institute
Miami
Finlay Medical Research
Miami
Optimus Clinical Research
Miami
Pharmax Research Clinic
Miami
Vitae Research Center, LLC
Miami
Gutierrez Medical Center LLD
Orlando
Neurology Associates of Ormond Beach
Ormond Beach
Palm Beach Neurological Center
Palm Beach
IMIC Inc
Palmetto Bay
Synergy Clinical Research
Pensacola
Quantum Laboratories
Pompano Beach
Illinois
Neurosciences Research
Elk Grove Village
North Carolina
Alzheimers Memory Center
Charlotte
New Jersey
Hassman Research Institute
Berlin
Advanced Memory Research Institute of NJ PC
Toms River
New York
Integrative Clinical Trials
Brooklyn
Neurological Associates of Long Island
Lake Success
Manhattan Behavioral Medicine PLLC
New York
Ohio
Neurology Diagnostics, Inc.
Dayton
MDH Research
Westerville
Oregon
Summit Research Network
Portland
Pennsylvania
Lehigh Center for Clinical Research
Allentown
Tennessee
Neurology Clinic, P.C.
Cordova
Utah
Aspen Clinical Research
Orem
Wasatch Clinical Research, LLC
Salt Lake City
Time Frame
Start Date: 2019-04-30
Completion Date: 2020-02-04
Participants
Target number of participants: 255
Treatments
Experimental: BPN14770 10mg bid
10 mg bid dose of the Drug BPN14770
Experimental: BPN 14770 25mg bid
25mg bid dose of the Drug BPN14770
Placebo_comparator: Placebo
Related Therapeutic Areas
Sponsors
Leads: Tetra Discovery Partners

This content was sourced from clinicaltrials.gov

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