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BPN14770 for Early Alzheimer's (PICASSO)

Start: April 30, 2019
End: February 2020
Enrollment: 255

What Is This Study About?

This Phase 2 trial will test the effects of different doses of the experimental drug BPN14770 in people with early-stage Alzheimer's disease. BPN14770, a small molecule that affects a protein involved in cognition and memory, is being investigated for its potential to treat memory loss and improve cognitive function. 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.

Do I Qualify To Participate in This Study?

Minimum Age: 55 Years

Maximum Age: 85 Years

Must have:

  • 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 two months and not expect changes; memantine is not permitted and must be discontinued at least three 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 two 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 one 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 six 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

Must NOT have:

  • Any medical or neurological condition other than early-stage Alzheimer's that might contribute to cognitive impairment
  • History of stroke or more than three 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 six 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 two 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 four weeks, or blood products within two 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 three months prior to screening

If I Qualify, Who Do I Contact?

Contact study personnel listed either under the general study contact or the location nearest you.

 

Need Help?

Contact NIA’s Alzheimer’s and related Dementias Education and Referral (ADEAR) Center at 800-438-4380 or email ADEAR.

Where Is This Study Located?

Who Sponsors This Study?

Lead: Tetra Discovery Partners

Source: ClinicalTrials.gov ID: NCT03817684