A Multicenter, Double Blind, Placebo-Controlled, Safety and Tolerability Study of BMS-708163 in Patients With Prodromal Alzheimer's Disease



Status:Terminated
Conditions:Alzheimer Disease
Therapuetic Areas:Neurology
Healthy:No
Age Range:45 - 90
Updated:4/21/2016
Start Date:May 2009
End Date:July 2013

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Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Tolerability, Pharmacodynamic and Pharmacokinetic Effects of BMS-708163 in the Treatment of Patients With Prodromal Alzheimer's Disease

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.


Inclusion Criteria:

- 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 Criteria:

- 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
We found this trial at
51
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Long Beach, California 90806
1171
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
1444
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Boston, MA
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911 E. Hallandale Beach Blvd
Hallandale Beach, Florida 33009
954-455-5757
1313
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Hallandale Beach, FL
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116th St and Broadway
New York, New York 10027
(212) 854-1754
Columbia University In 1897, the university moved from Forty-ninth Street and Madison Avenue, where it...
1290
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New York, NY
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100 West Gore St # 202
Orlando, Florida 32806
(407) 426-9299
Compass Research LLC Compass Research is a clinical research company dedicated to testing new medications...
1141
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Orlando, FL
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
1383
mi
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Portland, OR
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601 Elmwood Avenue
Rochester, New York 14642
(585) 275-2100
Univ of Rochester Medical Center One of the nation's top academic medical centers, the University...
1121
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Rochester, NY
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1000 Regency Court
Toledo, Ohio 43623
419-841-7369
800
mi
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Toledo, OH
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511
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Austin, TX
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Brooklyn, New York 11235
1290
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Brooksville, Florida
1093
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Brooksville, FL
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Calgary, Alberta
1214
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Calgary,
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281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
810
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Dallas, Texas 75235
356
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Dallas, TX
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Delray Beach, Florida 33445
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Denver, Colorado 80239
402
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Denver, CO
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
1052
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Durham, NC
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Eatontown, New Jersey 07724
1284
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Eatontown, NJ
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Fresno, California 93720
1204
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Fresno, CA
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545 Barnhill Dr
Indianapolis, Indiana 46201
(317) 274-8157
Indiana University Medical Center Indiana University Health is Indiana
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Indianapolis, IN
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961
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Las Vegas, NV
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Los Angeles, California 90095
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Los Angeles, CA
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572
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Middleton, WI
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Milwaukee, Wisconsin 53226
630
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New Brunswick, New Jersey 08903
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333 Cedar St
New Haven, Connecticut 06504
(203) 432-4771
Yale University School of Medicine Founded in 1810, the Yale School of Medicine is a...
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New York, New York 10016
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Newport Beach, California 92660
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Norwich, Connecticut 06360
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Orange, California 92868
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Paducah, Kentucky 42003
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Peoria, Arizona 85381
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Phoenix, Arizona 85004
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Phoenix, Arizona 85006
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Portland, OR
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Princeton, New Jersey 08540
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Princeton, NJ
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345 Blackstone Blvd
Providence, Rhode Island 02906
(401) 455-6200
Butler Hospital Founded in 1844, Butler Hospital is the state's only non-profit, free-standing psychiatric hospital...
1424
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Providence, RI
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Raleigh, North Carolina 27607
1064
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Raleigh, NC
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Raleigh, North Carolina 27609
1068
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Saint Louis, Missouri 63110
415
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San Diego, California 92103
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San Diego, California 92108
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San Diego, California 92093
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1178
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Sherman Oaks, CA
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St. Louis, Missouri 63108
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Sun City, Arizona 85351
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Toms River, New Jersey 08755
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Tulsa, Oklahoma 74104
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Winston Salem, North Carolina 27103
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Winston-Salem, North Carolina 26157
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