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)
Pivotal Research Centers
🇺🇸Peoria, Arizona, United States
Nyu Langone Medical Center
🇺🇸New York, New York, United States
Yale University School Of Medicine
🇺🇸New Haven, Connecticut, United States
Sun Health Research Institue
🇺🇸Sun City, Arizona, United States
Memory Enhancement Center Of Amercia, Inc.
🇺🇸Eatontown, New Jersey, United States
Global Medical Institutes, Llc
🇺🇸Princeton, New Jersey, United States
The Ohio State University
🇺🇸Columbus, Ohio, United States
Four Rivers Clinical Research, Inc
🇺🇸Paducah, Kentucky, United States
The University Of Texas
🇺🇸Dallas, Texas, United States
University Of Rochester Medical Center
🇺🇸Rochester, New York, United States
Neurology & Neuroscience Center Of Ohio
🇺🇸Toledo, Ohio, United States
Butler Hospital
🇺🇸Providence, Rhode Island, United States
Local Institution
🇸🇪Stockholm, Sweden
Richard H. Weisler, Md, Pa & Assoc.
🇺🇸Raleigh, North Carolina, United States
Robert Wood Johnson Medical School, Umdnj
🇺🇸New Brunswick, New Jersey, United States
Uc Irvine Medical Center
🇺🇸Orange, California, United States
Radiant Research, Inc.
🇺🇸Denver, Colorado, United States
Tulsa Clinical Research, Llc
🇺🇸Tulsa, Oklahoma, United States
Compass Research, Llc
🇺🇸Orlando, Florida, United States
St Louis University
🇺🇸Saint Louis, Missouri, United States
Raleigh Neurology Associates, Pa
🇺🇸Raleigh, North Carolina, United States
Memory Enhancement Center Of Nj, Inc.
🇺🇸Toms River, New Jersey, United States
Md Clinical
🇺🇸Hallandale Beach, Florida, United States
Pharmacology Research Institute
🇺🇸Newport Beach, California, United States
Mary S. Easton Center
🇺🇸Los Angeles, California, United States
California Neuroscience Research Medical Group, Inc.
🇺🇸Sherman Oaks, California, United States
Wake Forest University School Of Medicine
🇺🇸Winston-Salem, North Carolina, United States
Clinical Trials Of America, Inc.
🇺🇸Winston Salem, North Carolina, United States
Oregon Health & Science University
🇺🇸Portland, Oregon, United States
Mcw Clinics At Froedtert Hospital
🇺🇸Milwaukee, Wisconsin, United States
Senior Adults Specialty Research (Sasr)
🇺🇸Austin, Texas, United States
Dean Foundation For Health Research & Education
🇺🇸Middleton, Wisconsin, United States
21st Century Neurology
🇺🇸Phoenix, Arizona, United States
Banner Alzheimer'S Institute
🇺🇸Phoenix, Arizona, United States
Affiliated Research Institute
🇺🇸San Diego, California, United States
University Of California, San Diego
🇺🇸San Diego, California, United States
Pacific Research Network
🇺🇸San Diego, California, United States
Indiana University Medical Center
🇺🇸Indianapolis, Indiana, United States
Brigham & Women'S Hospital
🇺🇸Boston, Massachusetts, United States
Cleveland Clinic Lou Ruvo Center For Brain Health
🇺🇸Las Vegas, Nevada, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
University Of Alabama At Birmingham
🇺🇸Birmingham, Alabama, United States
Margolin Brain Institute
🇺🇸Fresno, California, United States
Comprehensive Psychiatric Care
🇺🇸Norwich, Connecticut, United States
Meridien Research
🇺🇸Brooksville, Florida, United States
Columbia University
🇺🇸New York, New York, United States
Washington University School Of Medicine
🇺🇸St. Louis, Missouri, United States
Spri Clinical Trials, Llc
🇺🇸Brooklyn, New York, United States
Brain Matters Research
🇺🇸Delray Beach, Florida, United States
Collaborative Neuroscience Network, Inc.
🇺🇸Long Beach, California, United States
Providence Cognitive Assessment Clinic
🇺🇸Portland, Oregon, United States