Status:
TERMINATED
A Multicenter, Double Blind, Placebo-Controlled, Safety and Tolerability Study of BMS-708163 in Patients With Prodromal Alzheimer's Disease
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Alzheimer's Disease
Eligibility:
All Genders
45-90 years
Phase:
PHASE2
Brief Summary
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 patien...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
263 Patients enrolled
Trial Details
Trial ID
NCT00890890
Start Date
May 1 2009
End Date
July 1 2013
Last Update
October 12 2015
Active Locations (64)
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1
University Of Alabama At Birmingham
Birmingham, Alabama, United States, 35294
2
Pivotal Research Centers
Peoria, Arizona, United States, 85381
3
21st Century Neurology
Phoenix, Arizona, United States, 85004
4
Banner Alzheimer'S Institute
Phoenix, Arizona, United States, 85006