A Multicenter, Double Blind, Placebo-Controlled, Safety and Tolerability Study of BMS-708163 in Patients With Prodromal Alzheimer's Disease
NCT ID: NCT00890890
Last Updated: 2015-10-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
263 participants
INTERVENTIONAL
2009-05-31
2013-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Avagacestat (50 mg)
Avagacestat
Capsules, Oral, 50 mg, once daily, 104 - 220 Weeks
Placebo
Placebo
Capsules, Oral, 0 mg, once daily, 104 - 220 Weeks
Interventions
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Avagacestat
Capsules, Oral, 50 mg, once daily, 104 - 220 Weeks
Placebo
Capsules, Oral, 0 mg, once daily, 104 - 220 Weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
45 Years
90 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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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
Pacific Research Network
San Diego, California, United States
Affiliated Research Institute
San Diego, California, United States
University Of California, San Diego
San Diego, California, United States
California Neuroscience Research Medical Group, Inc.
Sherman Oaks, California, United States
Radiant Research, Inc.
Denver, Colorado, United States
Yale University School Of Medicine
New Haven, Connecticut, United States
Comprehensive Psychiatric Care
Norwich, Connecticut, United States
Meridien Research
Brooksville, Florida, United States
Brain Matters Research
Delray Beach, Florida, United States
Md Clinical
Hallandale, Florida, United States
Compass Research, Llc
Orlando, Florida, United States
Indiana University Medical Center
Indianapolis, Indiana, United States
Four Rivers Clinical Research, Inc
Paducah, Kentucky, United States
Brigham & Women'S Hospital
Boston, Massachusetts, United States
St Louis University
St Louis, Missouri, United States
Washington University School Of Medicine
St Louis, Missouri, United States
Cleveland Clinic Lou Ruvo Center For Brain Health
Las Vegas, Nevada, United States
Memory Enhancement Center Of Amercia, Inc.
Eatontown, New Jersey, United States
Robert Wood Johnson Medical School, Umdnj
New Brunswick, New Jersey, United States
Global Medical Institutes, Llc
Princeton, New Jersey, United States
Memory Enhancement Center Of Nj, Inc.
Toms River, New Jersey, United States
Spri Clinical Trials, Llc
Brooklyn, New York, United States
Nyu Langone Medical Center
New York, New York, United States
Columbia University
New York, New York, United States
University Of Rochester Medical Center
Rochester, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Raleigh Neurology Associates, Pa
Raleigh, North Carolina, United States
Richard H. Weisler, Md, Pa & Assoc.
Raleigh, North Carolina, United States
Clinical Trials Of America, Inc.
Winston-Salem, North Carolina, United States
Wake Forest University School Of Medicine
Winston-Salem, North Carolina, United States
The Ohio State University
Columbus, Ohio, United States
Neurology & Neuroscience Center Of Ohio
Toledo, Ohio, United States
Tulsa Clinical Research, Llc
Tulsa, Oklahoma, United States
Providence Cognitive Assessment Clinic
Portland, Oregon, United States
Oregon Health & Science University
Portland, Oregon, United States
Butler Hospital
Providence, Rhode Island, United States
Senior Adults Specialty Research (Sasr)
Austin, Texas, United States
The University Of Texas
Dallas, Texas, United States
Dean Foundation For Health Research & Education
Middleton, Wisconsin, United States
Mcw Clinics At Froedtert Hospital
Milwaukee, Wisconsin, United States
Local Institution
Calgary, Alberta, Canada
Local Institution
Vancouver, British Columbia, Canada
Local Institution
London, Ontario, Canada
Local Institution
Toronto, Ontario, Canada
Local Institution
Greenfield Park, Quebec, Canada
Local Institution
Copenhagen, , Denmark
Local Institution
Turku, , Finland
Local Institution
Toulouse, Cedex 9, France
Local Institution
Bordeaux, , France
Local Institution
Dijon, , France
Local Institution
Nantes, , France
Local Institution
Rennes, , France
Local Institution
Mölndal, , Sweden
Local Institution
Stockholm, , Sweden
Countries
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References
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Coric V, Salloway S, van Dyck CH, Dubois B, Andreasen N, Brody M, Curtis C, Soininen H, Thein S, Shiovitz T, Pilcher G, Ferris S, Colby S, Kerselaers W, Dockens R, Soares H, Kaplita S, Luo F, Pachai C, Bracoud L, Mintun M, Grill JD, Marek K, Seibyl J, Cedarbaum JM, Albright C, Feldman HH, Berman RM. Targeting Prodromal Alzheimer Disease With Avagacestat: A Randomized Clinical Trial. JAMA Neurol. 2015 Nov;72(11):1324-33. doi: 10.1001/jamaneurol.2015.0607.
Related Links
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BMS clinical trial educational resource
Investigator Inquiry form
Other Identifiers
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2009-010067-16
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CN156-018
Identifier Type: -
Identifier Source: org_study_id
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