Alzheimer's Disease
Conditions
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
Interventions
DRUGBMS-708163
Capsules, Oral, 25 mg, once daily, 24 weeks
DRUGPlacebo
Capsules, Oral, 0 mg, once daily, 24 weeks
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Pharmacodynamics effects of the Alzheimer's Disease Assessment Scale - Cognitive Subscale | Baseline, Week 12, Week 24 and Week 36 |
| Pharmacodynamics effects of the Alzheimer's Disease Collaborative Study - Activities of Daily Living scale | 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 | Baseline, Week 12, Week 24 and Week 36 |
| Pharmacodynamics effects of Cerebral Spinal Fluid | 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 |
| Characterize Pharmacodynamics/Pharmacokinetics effects by exploring correlations between exposure, biomarkers, and clinical effects | Baseline, Week 12 and Week 24 |
| 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 of the plasma exposure of BMS-708163 and variability in a population with Alzheimer's disease | Baseline, Week 12 and Week 24 |
Countries
Denmark, Finland, Sweden, United States
Outcome results
None listed