A Multicenter, Double Blind, Placebo-Controlled, Safety and Tolerability Study of BMS-708163 in Patients With Prodromal Alzheimer's Disease
| Status: | Terminated |
|---|---|
| Conditions: | Alzheimer Disease |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 45 - 90 |
| Updated: | 4/21/2016 |
| Start Date: | May 2009 |
| End Date: | July 2013 |
Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Tolerability, Pharmacodynamic and Pharmacokinetic Effects of BMS-708163 in the Treatment of Patients With Prodromal Alzheimer's Disease
The purpose of this study is to determine the safety and tolerability of BMS-708163 in
patients with Prodromal Alzheimer's disease over a treatment period of a minimum of
104-weeks. In addition patients will be seen for safety visits at 4 and 12 weeks post
treatment.
patients with Prodromal Alzheimer's disease over a treatment period of a minimum of
104-weeks. In addition patients will be seen for safety visits at 4 and 12 weeks post
treatment.
Inclusion Criteria:
- Patient meets clinical criteria for prodromal Alzheimer's disease (MMSE 24-30)
- Memory complaint by subject or study partner
- CSF aβ42 levels < 200pg/mL or Total Tau/aβ42 ratio of ≥ 0.39
- Score of ≤4 on the Modified Hachinski Ischemia Scale
- CT results consistent with Alzheimer's disease
- Medically stable
- 6 years education
- Reliable study partner
- Must be able to swallow capsules
Exclusion Criteria:
- Premenopausal women
- DSM-IV diagnosis of Dementia 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
- 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
51
sites
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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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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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
Portland, Oregon 97239
503 494-8311
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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Univ of Rochester Medical Center One of the nation's top academic medical centers, the University...
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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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Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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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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