A Multicenter, Double Blind, Placebo-Controlled, Safety and Tolerability Study of BMS-708163 in Patients With Prodromal Alzheimer's Disease
- Registration Number
- NCT00890890
- Lead Sponsor
- Bristol-Myers Squibb
- 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 patients will be seen for safety visits at 4 and 12 weeks post treatment.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 263
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo - Avagacestat (50 mg) Avagacestat -
- Primary Outcome Measures
Name Time Method Safety and tolerability of BMS-708163 in patients with Prodromal Alzheimer's disease as measured by adverse events, vital signs, laboratory assessments, electrocardiograms (ECGs) and Safety Head Magnetic resonance imaging (MRI) findings Avagacestat-treated patients will have a 24 week post treatment skin examination by a dermatologist
- Secondary Outcome Measures
Name Time Method Predictive value of Cerebral Spinal Fluid (CSF) biomarkers (Aβ40, and Aβ42, total Tau, total Tau/Aβ42 ratio, phosphorylated Tau) on progression to dementia Baseline (Week 0), Week 2 (optional), Week 24 and Week 104
Trial Locations
- Locations (51)
University Of Alabama At Birmingham
🇺🇸Birmingham, Alabama, United States
Pivotal Research Centers
🇺🇸Peoria, Arizona, United States
21st Century Neurology
🇺🇸Phoenix, Arizona, United States
Banner Alzheimer'S Institute
🇺🇸Phoenix, Arizona, United States
Sun Health Research Institue
🇺🇸Sun City, Arizona, United States
Margolin Brain Institute
🇺🇸Fresno, California, United States
Collaborative Neuroscience Network, Inc.
🇺🇸Long Beach, California, United States
Mary S. Easton Center
🇺🇸Los Angeles, California, United States
Pharmacology Research Institute
🇺🇸Newport Beach, California, United States
Uc Irvine Medical Center
🇺🇸Orange, California, United States
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