A Phase II, Multicenter, Double Blind, Placebo-Controlled Safety, Tolerability Study of BMS-708163 in Patients With Mild to Moderate Alzheimer's Disease
| Status: | Completed |
|---|---|
| Conditions: | Alzheimer Disease |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 50 - 90 |
| Updated: | 4/21/2016 |
| Start Date: | February 2009 |
| End Date: | June 2010 |
Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Tolerability, Pharmacodynamic and Pharmacokinetic Effects of BMS-708163 in the Treatment of Patients With Mild to Moderate Alzheimer's Disease
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
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
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
We found this trial at
36
sites
Miami Research Associates Miami Research Associates (MRA) is the largest privately-owned multi-specialty clinical research center...
Click here to add this to my saved trials
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
Click here to add this to my saved trials
Click here to add this to my saved trials
Columbia University In 1897, the university moved from Forty-ninth Street and Madison Avenue, where it...
Click here to add this to my saved trials
Compass Research LLC Compass Research is a clinical research company dedicated to testing new medications...
Click here to add this to my saved trials
University of Rochester The University of Rochester is one of the country's top-tier research universities....
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Indiana University Medical Center Indiana University Health is Indiana
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Yale University School of Medicine Founded in 1810, the Yale School of Medicine is a...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Butler Hospital Founded in 1844, Butler Hospital is the state's only non-profit, free-standing psychiatric hospital...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials