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 |
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
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
Compass Research LLC Compass Research is a clinical research company dedicated to testing new medications...
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Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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3400 Spruce St
Philadelphia, Pennsylvania 19104
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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Anaheim Clinical Trials, LLC Anaheim Clinical Trials (ACT) is a research center of excellence for...
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Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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