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BPN14770 for Early Alzheimer's (PICASSO)

Active, not recruiting

This Phase II trial will test the effects of different doses of the experimental drug BPN14770 in people with early-stage Alzheimer's disease. BPN14770 is being investigated for its potential to treat memory loss and improve cognitive function.

Minimum Age Maximum Age Gender Healthy Volunteers
55 Years 85 Years All No
April 30, 2019
February 2020
255

  • Clinical diagnosis of early-stage Alzheimer's disease, defined by the following criteria assessed during screening and baseline:
    • Clinical Dementia Rating score of 0.5 or 1, with Memory Box score of 0.5 or greater
    • Mini-Mental State Examination score of 20 or greater
    • Repeatable Battery for the Assessment of Neurological Status - Delayed Memory Index score of 85
  • If taking cholinesterase inhibitors (donepezil, galantamine, or rivastigmine), must be on a stable for at least 2 months and not expect changes; memantine is not permitted and must be discontinued at least 3 weeks prior to baseline
  • Modified Hachinski Ischemia score less than 4
  • Body mass index less than 38, and body weight greater than 105 pounds
  • If female, must be at least 2 years post-menopausal, surgically sterile, or willing to use either hormonal contraception plus one barrier method or two barrier methods (e.g., diaphragm and spermicide) from initial screening until 1 month after final dose
  • If male, must be willing to inform female partners of study participation and agree to use adequate contraceptive methods (e.g., vasectomy at least 6 months prior to study drug administration or at least one barrier method)
  • Able to understand and comply with study procedures, voluntarily agree to participate, and provide written informed consent
  • Caregiver who is willing and able to ensure compliance with study medications, visits, and study procedures

  • Any medical or neurological condition other than early-stage Alzheimer's that might contribute to cognitive impairment
  • History of stroke or more than 3 mini-strokes, severe head trauma with resulting cognitive condition, uncontrolled seizures, or unexplained prolonged loss of consciousness (longer than 1 minute) during the past year
  • Major psychiatric illness in past 6 months
  • History of unstable angina, heart attack, chronic heart failure, or significant conduction abnormalities during the past year
  • Significant liver or kidney disease
  • Significant abnormality in blood, chemistry, or urinalysis
  • Positive serology results for hepatitis B surface antigen or hepatitis C virus
  • Abnormal liver function test (aspartate aminotransferase or alanine aminotransferase greater than 2 times the upper limit of normal [ULN], or total bilirubin greater than 1.7 times ULN)
  • Low blood pressure (systolic 90 mmHg or diastolic 50 mmHg) or high blood pressure (systolic 160 mmHg or diastolic 100 mmHg)
  • Bradycardia (heart rate 45 beats per minute, bpm) or tachycardia (heart rate 115 bpm)
  • Conduction abnormalities on electrocardiogram, or evidence or history of long QT syndrome based
  • Active gastric or duodenal ulcers or other diseases of the gastrointestinal tract that could interfere with absorption of study drug (removal of appendix and gallbladder are allowed)
  • Active acute or chronic infectious diseases that would interfere with study participation
  • Unable to discontinue centrally active medications (other than cholinesterase inhibitors), including memantine, psychotropic drugs other than SSRIs (must be stable for at least 2 months), sedative antihistamines, or other centrally active medications with potential cognitive effects
  • Unable to discontinue moderate to strong inhibitors or inducers of CYP3A4, CYP2D6, or other cytochromes (view a complete listing) at least 14 days before taking the study drug; other drugs, such as antihypertensives or cholesterol lowering agents, are allowed if they won't interfere with the study
  • Suicidal ideation intensity score of 3 or higher per Columbia Suicide Severity Rating Scale and/or any suicidal behavior within the past 28 days
  • History of chronic alcohol or other substance abuse, including marijuana, within the past year, 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 oz wine, or 1.5 oz distilled spirits)
  • Participation in another clinical study involving an investigational drug in past 30 days
  • Donation of blood within 4 weeks, or blood products within 2 weeks, prior to study drug administration
  • History of clinically significant drug allergy that includes symptoms such as shortness of breath, rash, or edema
  • Significant B12 deficiency in past 12 months unless on stable replacement therapy for at least 3 months prior to screening

BPN14770 is a small molecule that inhibits phosphodiesterase enzymes, which are involved in cognition and memory. Participants in this study will be randomly assigned to take either 10 or 25 mg of the study drug or a placebo twice daily. Participants will undergo assessments and tests to measure changes in memory and function and to determine levels of the study drug in their blood.

Name City State Zip Status Primary Contact
Generations at Agritopia/CCT Research
Gilbert Arizona 85296

CiTrials, Inc.
Bellflower California 90709

ATP Clinical Research, Inc
Costa Mesa California 92626

Alliance for Research
Long Beach California 90807

Pacific Research Network Inc.
San Diego California 92103

HB Clinical Trials, Inc.
Santa Ana California 92704

Mile High Research Center
Denver Colorado 80218

JEM Research Insitute
Atlantis Florida 33462

Linfritz Research Group
Coral Gables Florida 33134

Brain Matters Research
Delray Beach Florida 33445

MD Clinical
Hallandale Beach Florida 33009

Galiz Research
Hialeah Florida 33016

Alzheimer's Research and Treatement Center
Lake Worth Florida 33449

Optimus Clinical Research
Miami Florida 33125

BioMed Research Institute
Miami Florida 33126

Finlay Medical Research
Miami Florida 33126

Pharmax Research Clinic
Miami Florida 33126

Vitae Research Center, LLC
Miami Florida 33135

Arocha Research Center
Miami Florida 33145

Allied Biomedical Research Institute Inc.
Miami Florida 33155

Advanced Clinical Research Network
Miami Florida 33176

Gutierrez Medical Center LLD
Orlando Florida 32807

Neurology Associates of Ormond Beach
Ormond Beach Florida 32174

Palm Beach Neurological Center
Palm Beach Florida 33410

IMIC Inc
Palmetto Bay Florida 33157

Synergy Clinical Research
Pensacola Florida 32514

Quantum Laboratories
Pompano Beach Florida 33064

Neurosciences Research
Elk Grove Village Illinois 60007

Hassman Research Institute
Berlin New Jersey 08009

Advanced Memory Research Institute of NJ PC
Toms River New Jersey 08755

Integrative Clinical Trials
Brooklyn New York 11229

Neurological Associates of Long Island
Lake Success New York 11042

Manhattan Behavioral Medicine PLLC
New York New York 10036

Alzheimers Memory Center
Charlotte North Carolina 28270

Neurology Diagnostics, Inc.
Dayton Ohio 45459

MDH Research
Westerville Ohio 43081

Summit Research Network
Portland Oregon 97210

Lehigh Center for Clinical Research
Allentown Pennsylvania 18104

Neurology Clinic, P.C.
Cordova Tennessee 38018

Aspen Clinical Research
Orem Utah 84058

Wasatch Clinical Research, LLC
Salt Lake City Utah 84107

Tetra Discovery Partners

Name Role Affiliation
Scott Reines, MD Study Director Tetra Discovery Partners

Name Phone Email
Chad Coberly, JD 616-224-0084 chad@tetradiscovery.com

NCT03817684

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