A Phase II, Multicenter, Double Blind, Placebo-Controlled Safety, Tolerability Study of BMS-708163 in Patients With Mild to Moderate Alzheimer's Disease
- Registration Number
- NCT00810147
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
The purpose of this study is to determine the safety and tolerability of BMS-708163 in patients with mild to moderate Alzheimer's disease over a treatment period of 12-weeks and the course of any potential effects during a 12-week wash-out period
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 209
- Clinical diagnosis of Mild to Moderate Alzheimer's disease (MMSE 16-26)
- 6 Month cognitive decline
- Stable marketed AD therapy x2 months or additional marketed AD therapy during study
- Score of <=4 on the Modified Hachinski Ischemia Scale
- CT results consistent with Alzheimer's disease
- Medically stable
- 6 years education
- Reliable study partner (caregiver)
- Must be able to swallow capsules
- Premenopausal women
- Dementia due to other causes than Alzheimer's disease
- History of stroke
- Immunocompromised
- Active peptic ulcer, GI bleed, chronic inflammatory bowel disease, chronic diarrhea or past GI surgery that would impact drug absorption
- Unstable Vitamin B-12 deficiency
- Hematologic or solid malignancy within 5 years
- Geriatric Depression Scale >= 6
- Unstable medical condition
- Alcohol or drug abuse history with 12-months of study entry
- Significant drug allergy
- Alzheimer's disease modification experimental therapy with 12 months of study entry
- Prisoners, compulsory psychiatric patients, or residents of nursing home or skilled nursing facility at entry
- Any other experimental therapy with 30-days of study entry
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A1 BMS-708163 - A5 Placebo - A2 BMS-708163 - A3 BMS-708163 - A4 BMS-708163 -
- Primary Outcome Measures
Name Time Method Adverse Events Weekly for the first 12-weeks of the 24-Week dosing period (Baseline-Week-12) and every 2 weeks during the second 12-weeks of the 24-Week dosing period (Weeks 14-24) and during the subsequent 12-week washout period (Weeks 28, 32, & 36)
- Secondary Outcome Measures
Name Time Method Pharmacodynamics effects of the Global clinical impression as assessed with the Clinical Dementia Rating-Sum of Boxes Baseline, Week 12, Week 24 and Week 36 Characterize Pharmacodynamics/Pharmacokinetics effects of the plasma exposure of BMS-708163 and variability in a population with Alzheimer's disease Baseline, Week 12 and Week 24 Pharmacodynamics effects of the Alzheimer's Disease Collaborative Study - Activities of Daily Living scale Baseline, Week 12, Week 24 and Week 36 Characterize Pharmacodynamics/Pharmacokinetics effects by exploring correlations between exposure, biomarkers, and clinical effects Baseline, Week 12 and Week 24 Pharmacodynamics effects of Cerebral Spinal Fluid Baseline, Week 12 and Week 24 Pharmacodynamics effects of the Alzheimer's Disease Assessment Scale - Cognitive Subscale Baseline, Week 12, Week 24 and Week 36 Characterize Pharmacodynamics/Pharmacokinetics effects by exploring Pharmacokinetics variability, including the correlation between polymorphisms of CYP enzymes Baseline, Week 12 and Week 24 Characterize Pharmacodynamics/Pharmacokinetics effects in refining the Pharmacokinetics/Pharmacodynamics model with Phase 2 data Baseline, Week 12 and Week 24
Trial Locations
- Locations (36)
Yale University School Of Medicine
🇺🇸New Haven, Connecticut, United States
Global Medical Institutes, Llc
🇺🇸Princeton, New Jersey, United States
University Of Rochester
🇺🇸Rochester, New York, United States
Memory Enhancement Center Of Amercia, Inc.
🇺🇸Eatontown, New Jersey, United States
Sun Health Research Institue
🇺🇸Sun City, Arizona, United States
Md Clinical
🇺🇸Hallandale Beach, Florida, United States
Collaborative Neuroscience Network, Inc.
🇺🇸Garden Grove, California, United States
Brain Matters Research
🇺🇸Delray Beach, Florida, United States
Meridien Research
🇺🇸Brooksville, Florida, United States
Compass Research, Llc
🇺🇸Orlando, Florida, United States
University Of Alabama At Birmingham
🇺🇸Birmingham, Alabama, United States
Comprehensive Psychiatric Care
🇺🇸Norwich, Connecticut, United States
Margolin Brain Institute
🇺🇸Fresno, California, United States
Neurology & Neuroscience Center Of Ohio
🇺🇸Toledo, Ohio, United States
Miami Research Associates
🇺🇸South Miami, Florida, United States
Center For Clinical Trials
🇺🇸Venice, Florida, United States
R.I. Mood & Memory Research Institute
🇺🇸East Providence, Rhode Island, United States
The University Of Texas
🇺🇸Dallas, Texas, United States
The Clinical Trial Center Llc
🇺🇸Jenkintown, Pennsylvania, United States
Butler Hospital
🇺🇸Providence, Rhode Island, United States
Richard H. Weisler, Md, Pa & Associates
🇺🇸Raleigh, North Carolina, United States
Tulsa Clinical Research, Llc
🇺🇸Tulsa, Oklahoma, United States
21st Century Neurology
🇺🇸Phoenix, Arizona, United States
Pacific Institute For Medical Research, Inc.
🇺🇸Los Angeles, California, United States
Pacific Research Network, Inc
🇺🇸San Diego, California, United States
Banner Alzheimer'S Institute
🇺🇸Phoenix, Arizona, United States
Mary S. Easton Center
🇺🇸Los Angeles, California, United States
The Ohio State University
🇺🇸Columbus, Ohio, United States
Local Institution
🇸🇪Stockholm, Sweden
California Neuroscience Research Medical Group, Inc.
🇺🇸Sherman Oaks, California, United States
Indiana University Medical Center
🇺🇸Indianapolis, Indiana, United States
Usf Suncoast Alzheimer'S And Gerontology Center
🇺🇸Tampa, Florida, United States
Four Rivers Clinical Research, Inc
🇺🇸Paducah, Kentucky, United States
Columbia University
🇺🇸New York, New York, United States
Professional Neurological Associates, Pc
🇺🇸Dunmore, Pennsylvania, United States
Dean Foundation For Health Research & Education
🇺🇸Middleton, Wisconsin, United States