Study to Evaluate the Safety, Tolerability and the Effect of BMS-241027 on Cerebrospinal Fluid Biomarkers in Subjects With Mild Alzheimer's Disease



Status:Completed
Conditions:Alzheimer Disease
Therapuetic Areas:Neurology
Healthy:No
Age Range:50 - 90
Updated:5/5/2014
Start Date:February 2012
End Date:October 2014
Contact:For participation information at a USA site use a phone number below. For site information outside the USA please email:
Email:Clinical.Trials@bms.com

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A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability and the Effect of BMS-241027 on Cerebrospinal Fluid Biomarkers in Subjects With Mild Alzheimer's Disease

The purpose of the study is to evaluate safety and the pharmacodynamic effects of BMS-241027
on cerebrospinal fluid (CSF) Tau, connectivity magnetic resonance imaging (MRI), and
computerized cognitive tests in mild Alzheimer's disease (AD) subjects, following 9 weekly
intravenous (IV) infusions of BMS-241027


Inclusion Criteria:

- Mild AD Subjects meeting National Institute of Neurological Disorders and Stroke -
Alzheimer's Disease Related Disorders Association(NINCDS-ADRDA) and Diagnostic and
Statistical Manual of Mental Disorders-Forth Edition, Text Revision (DSM-IV-TR)
criteria

- Mini-Mental State Exam (MMSE) Score between 20 & 26 (inclusive)

- CSF consistent with AD pathology

- Screening brain MRI - normal - commensurate with age or demonstrate atrophy
consistent with AD diagnosis (dx); reveal no more than mild white matter disease; up
to 2 lacunar infarcts acceptable except in anterior thalamus, genu of internal
capsule or basal forebrain; reveal no cortical infarcts; reveal no more than 4
microbleeds; reveal no focal asymmetric lobar atrophy or other findings suggesting
primary cause of dementia is attributed to a cause other than AD; reveal no
macrohemorrhages (>10 mm)

- Subjects must have reliable study partners

- Men and Women of Non Child Bearing Potentia (WONCBP), ages 50-90 years

Exclusion Criteria:

- Subjects with any other medical condition other than mild AD that could explain
subjects' memory or cognitive deficits

- Subjects diagnosed with moderate or severe AD per DSM-IV criteria

- Subjects with a history (hx) of stroke

- Subjects with a hx of GI illnesses

- Subjects with Vitamin B12 or folate deficiency

- Subjects with any unstable cardiovascular (CV), pulmonary, Gastrointestinal (GI) or
hepatic disease within 30 days prior to screening

- Subjects with active liver dx or history of hepatic intolerance

- Subjects with a Geriatric Depression Scale score of ≥ 6 at screening

- Subjects treated for or have had a diagnosis of schizophrenia

- Subjects treated for or have had a diagnosis of bipolar disease within 3 years prior
to screening

- Subjects with a history of generalized peripheral neuropathy
We found this trial at
17
sites
3838 South 700 East
Salt Lake City, Utah 84106
801-269-8200
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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...
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1000 Alpine
Boulder, Colorado 80304
303-443-7229
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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...
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3400 Spruce St
Philadelphia, Pennsylvania 19104
 (215) 662-4000
Hospital of the University of Pennsylvania The Hospital of the University of Pennsylvania (HUP) is...
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1085 N Harbor Blvd
Anaheim, California 92801
(714) 774-7777
Anaheim Clinical Trials, LLC Anaheim Clinical Trials (ACT) is a research center of excellence for...
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Atlanta, Georgia 30342
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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...
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Fairfield, CT
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Garden Grove, California 92845
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Jenkintown, Pennsylvania 19046
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409 West Circle Drive
Lansing, Michigan 48910
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Philadelphia, Pennsylvania 19104
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San Francisco, California 94143
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Tucson, Arizona 85724
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