A Phase II, Multicenter, Double Blind, Placebo-Controlled Safety, Tolerability Study of BMS-708163 in Patients With Mild to Moderate Alzheimer's Disease

Phase 2

Completed

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

Recruitment & Eligibility

Inclusion Criteria

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

Exclusion Criteria

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

Arm && Interventions

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

Locations (36): 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
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University Of Alabama At Birmingham
🇺🇸Birmingham, Alabama, United States