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
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University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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Columbia University In 1897, the university moved from Forty-ninth Street and Madison Avenue, where it...
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Compass Research LLC Compass Research is a clinical research company dedicated to testing new medications...
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University of Rochester The University of Rochester is one of the country's top-tier research universities....
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Miami Research Associates Miami Research Associates (MRA) is the largest privately-owned multi-specialty clinical research center...
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Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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Indiana University Medical Center Indiana University Health is Indiana
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Yale University School of Medicine Founded in 1810, the Yale School of Medicine is a...
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Butler Hospital Founded in 1844, Butler Hospital is the state's only non-profit, free-standing psychiatric hospital...
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