Study to Evaluate the Safety, Tolerability and the Effect of BMS-241027 on Cerebrospinal Fluid Biomarkers in Subjects With Mild Alzheimer's Disease
NCT ID: NCT01492374
Last Updated: 2014-07-24
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
PHASE1
40 participants
INTERVENTIONAL
2012-02-29
2013-10-31
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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Arm 1: BMS-241027 (0.003 mg/kg)
BMS-241027
Intravenous (IV), 0.003 mg/kg, Once Weekly, 9 weeks
Arm 2: BMS-241027 (0.01 mg/kg)
BMS-241027
Intravenous (IV), 0.01 mg/kg, Once Weekly, 9 weeks
Arm 3: BMS-241027 (0.03 mg/kg)
BMS-241027
Intravenous (IV), 0.03 mg/kg, Once Weekly, 9 weeks
Arm 4: Placebo matching BMS-241027
Placebo matching BMS-241027
Intravenous (IV), 0.0 mg/kg, Once Weekly, 9 weeks
Interventions
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BMS-241027
Intravenous (IV), 0.003 mg/kg, Once Weekly, 9 weeks
BMS-241027
Intravenous (IV), 0.01 mg/kg, Once Weekly, 9 weeks
BMS-241027
Intravenous (IV), 0.03 mg/kg, Once Weekly, 9 weeks
Placebo matching BMS-241027
Intravenous (IV), 0.0 mg/kg, Once Weekly, 9 weeks
Eligibility Criteria
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Inclusion 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 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
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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Anaheim Clinical Trials Llc
Anaheim, California, United States
Long Beach, California, United States
Ucsf Memory And Aging Center
San Francisco, California, United States
Alpine Clinical Research Center, Inc.
Boulder, Colorado, United States
Associated Neurologists Of Southern Connecticut, P.C.
Fairfield, Connecticut, United States
Compass Research, Llc
Orlando, Florida, United States
Palm Beach Neurological Center Advanced Research Consultants
Palm Beach Gardens, Florida, United States
Alexian Brothers Neurosciences Institute Clinical Research
Elk Grove Village, Illinois, United States
Brigham And Women'S Hospital
Boston, Massachusetts, United States
Michigan State University
East Lansing, Michigan, United States
The Ohio State University
Columbus, Ohio, United States
The Clinical Trial Center, Llc
Jenkintown, Pennsylvania, United States
Hospital Of The University Of Pennsylvania
Philadelphia, Pennsylvania, United States
Penn Memory Center
Philadelphia, Pennsylvania, United States
Lifetree Clinical Research
Salt Lake City, Utah, United States
Local Institution
London, Ontario, Canada
Local Institution
Toronto, Ontario, Canada
Local Institution
Greenfield Park, Quebec, Canada
Local Institution
Toulouse, Cedex 9, France
Local Institution
Lille, , France
Local Institution
Paris, , France
Local Institution
Berlin, , Germany
Local Institution
Heidelberg, , Germany
Local Institution
Stockholm, , Sweden
Countries
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Related Links
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BMS clinical trial educational resource
Investigator Inquiry form
Other Identifiers
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2011-004065-33
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CN167-003
Identifier Type: -
Identifier Source: org_study_id
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