A Phase II, Multicenter, Double Blind, Placebo-Controlled Safety, Tolerability Study of BMS-708163 in Patients With Mild to Moderate Alzheimer's Disease
NCT ID: NCT00810147
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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COMPLETED
PHASE2
209 participants
INTERVENTIONAL
2009-02-28
2010-06-30
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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A1
BMS-708163
Capsules, Oral, 25 mg, once daily, 24 weeks
A2
BMS-708163
Capsules, Oral, 50 mg, once daily, 24 weeks
A3
BMS-708163
Capsules, Oral, 100 mg, once daily, 24 weeks
A4
BMS-708163
Capsules, Oral, 125 mg, once daily, 24 weeks
A5
Placebo
Capsules, Oral, 0 mg, once daily, 24 weeks
Interventions
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BMS-708163
Capsules, Oral, 25 mg, once daily, 24 weeks
BMS-708163
Capsules, Oral, 50 mg, once daily, 24 weeks
BMS-708163
Capsules, Oral, 100 mg, once daily, 24 weeks
BMS-708163
Capsules, Oral, 125 mg, once daily, 24 weeks
Placebo
Capsules, Oral, 0 mg, once daily, 24 weeks
Eligibility Criteria
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Inclusion Criteria
* 6 Month cognitive decline
* Stable marketed AD therapy x2 months or additional marketed AD therapy during study
* Score of \<=4 on the Modified Hachinski Ischemia Scale
* CT results consistent with Alzheimer's disease
* Medically stable
* 6 years education
* Reliable study partner (caregiver)
* Must be able to swallow capsules
Exclusion Criteria
* Dementia due to other causes than Alzheimer's disease
* 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
* Alzheimer's disease modification experimental therapy with 12 months of study entry
* 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
50 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
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.
Garden Grove, California, United States
Pacific Institute For Medical Research, Inc.
Los Angeles, California, United States
Mary S. Easton Center
Los Angeles, California, United States
Pacific Research Network, Inc
San Diego, California, United States
California Neuroscience Research Medical Group, Inc.
Sherman Oaks, California, 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
Miami Research Associates
South Miami, Florida, United States
Usf Suncoast Alzheimer'S And Gerontology Center
Tampa, Florida, United States
Center For Clinical Trials
Venice, Florida, United States
Indiana University Medical Center
Indianapolis, Indiana, United States
Four Rivers Clinical Research, Inc
Paducah, Kentucky, United States
Memory Enhancement Center Of Amercia, Inc.
Eatontown, New Jersey, United States
Global Medical Institutes, Llc
Princeton, New Jersey, United States
Columbia University
New York, New York, United States
University Of Rochester
Rochester, New York, United States
Richard H. Weisler, Md, Pa & Associates
Raleigh, 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
Professional Neurological Associates, Pc
Dunmore, Pennsylvania, United States
The Clinical Trial Center Llc
Jenkintown, Pennsylvania, United States
R.I. Mood & Memory Research Institute
East Providence, Rhode Island, United States
Butler Hospital
Providence, Rhode Island, United States
The University Of Texas
Dallas, Texas, United States
Dean Foundation For Health Research & Education
Middleton, Wisconsin, United States
Local Institution
Odense, , Denmark
Local Institution
Kuopio, , Finland
Local Institution
Turku, , Finland
Local Institution
Malmo, , Sweden
Local Institution
Mölndal, , Sweden
Local Institution
Stockholm, , Sweden
Countries
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References
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Coric V, van Dyck CH, Salloway S, Andreasen N, Brody M, Richter RW, Soininen H, Thein S, Shiovitz T, Pilcher G, Colby S, Rollin L, Dockens R, Pachai C, Portelius E, Andreasson U, Blennow K, Soares H, Albright C, Feldman HH, Berman RM. Safety and tolerability of the gamma-secretase inhibitor avagacestat in a phase 2 study of mild to moderate Alzheimer disease. Arch Neurol. 2012 Nov;69(11):1430-40. doi: 10.1001/archneurol.2012.2194.
Related Links
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Investigator Inquiry form
Other Identifiers
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EUDRACT: 2008-005929-11
Identifier Type: -
Identifier Source: secondary_id
CN156-013
Identifier Type: -
Identifier Source: org_study_id
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