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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
209
Capsules, Oral, 25 mg, once daily, 24 weeks
Capsules, Oral, 50 mg, once daily, 24 weeks
Capsules, Oral, 100 mg, once daily, 24 weeks
Adverse Events
Time frame: 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)
Pharmacodynamics effects of Cerebral Spinal Fluid
Time frame: Baseline, Week 12 and Week 24
Pharmacodynamics effects of the Alzheimer's Disease Assessment Scale - Cognitive Subscale
Time frame: Baseline, Week 12, Week 24 and Week 36
Pharmacodynamics effects of the Alzheimer's Disease Collaborative Study - Activities of Daily Living scale
Time frame: Baseline, Week 12, Week 24 and Week 36
Pharmacodynamics effects of the Global clinical impression as assessed with the Clinical Dementia Rating-Sum of Boxes
Time frame: 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
Time frame: Baseline, Week 12 and Week 24
Characterize Pharmacodynamics/Pharmacokinetics effects in refining the Pharmacokinetics/Pharmacodynamics model with Phase 2 data
Time frame: Baseline, Week 12 and Week 24
Characterize Pharmacodynamics/Pharmacokinetics effects by exploring correlations between exposure, biomarkers, and clinical effects
Time frame: Baseline, Week 12 and Week 24
Characterize Pharmacodynamics/Pharmacokinetics effects by exploring Pharmacokinetics variability, including the correlation between polymorphisms of CYP enzymes
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Capsules, Oral, 125 mg, once daily, 24 weeks
Capsules, Oral, 0 mg, once daily, 24 weeks
University Of Alabama At Birmingham
Birmingham, Alabama, United States
21st Century Neurology
Phoenix, Arizona, United States
Banner Alzheimer'S Institute
Phoenix, Arizona, United States
Sun Health Research Institue
Sun City, Arizona, United States
Margolin Brain Institute
Fresno, California, United States
Collaborative Neuroscience Network, Inc.
Garden Grove, California, United States
Pacific Institute For Medical Research, Inc.
Los Angeles, California, United States
Mary S. Easton Center
Los Angeles, California, United States
Pacific Research Network, Inc
San Diego, California, United States
California Neuroscience Research Medical Group, Inc.
Sherman Oaks, California, United States
...and 31 more locations
Time frame: Baseline, Week 12 and Week 24