Status:
COMPLETED
A Phase II, Multicenter, Double Blind, Placebo-Controlled Safety, Tolerability Study of BMS-708163 in Patients With Mild to Moderate Alzheimer's Disease
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Alzheimer's Disease
Eligibility:
All Genders
50-90 years
Phase:
PHASE2
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 pote...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
209 Patients enrolled
Trial Details
Trial ID
NCT00810147
Start Date
February 1 2009
End Date
June 1 2010
Last Update
October 12 2015
Active Locations (41)
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1
University Of Alabama At Birmingham
Birmingham, Alabama, United States, 35294
2
21st Century Neurology
Phoenix, Arizona, United States, 85004
3
Banner Alzheimer'S Institute
Phoenix, Arizona, United States, 85006
4
Sun Health Research Institue
Sun City, Arizona, United States, 85351