A Multicenter, Randomized, Couble-Blind, Placebo-Controlled Study of the Safety, Tolerability, Pharmacodynamic and Pharmacokinetic Effects of BMS-708163 in the Treatment of Patients with Prodromal Alzheimer’s Disease
Principle Investigator: Dr. Joseph Quinn
Sponsor: Bristol-Myers Squibb
Length: 104 weeks
Visits: 22 visits during 2 year treatment phase, 5 phone calls in between.
Purpose: To determine the safety, tolerability and potential pharmacodynamic effects of BMS-708613 125 mg/day versus placebo in patients with prodromal Alzheimer’s disease over a 104 week treatment period.
Study design: Multi-center, randomized, double-blind, placebo-controlled, 2 arm study. Patients will undergo physical, neurological, cognitive, clinical and lab assessments at screening including MRI. Patients must also have an LP performed at baseline which shows beta amyloid levels below 200 pg/mL for inclusion in trial. Throughout the study, patients will have a total of 6 MRIs and 3 lumbar punctures. Patients will have weekly clinic visits for medication dispensing and returns as well as other assessments for the first 9 weeks of the trial, then return monthly for the remainder of the six month treatment period. Patients who do not meet the CSF inclusion criteria but otherwise fulfill the study inclusion criteria may continue to be followed in an observational cohort for data collection on progression to dementia.
Study Care and Reimbursement: Study visits provided at no charge. Patients will be compensated $20/visit without LP and $100/visit with an LP
- Memory complaint by subject or study partner
- MMSE 24-30 inclusive
- Age 45-90
- Has a study partner willing to accompany the subject to all visits
- Use of approved anti-AD medication and on a stable dose for at least 3 months prior to baseline and anticipated stable use throughout the entire study period. Memantine is not allowed during study.
Contact: Lisa Loree at 503 494-7615