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

Completed · Phase 1 · Has a placebo group

Conditions studied: Alzheimer's Disease

In brief

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

Key facts

Study ID

NCT01492374

Run by

Bristol-Myers Squibb

People needed

40

Starts

2012-02-01

Expected to finish

2013-10-01

Last updated by the study team

2014-07-24

Who can join

Age: 50 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Anaheim Clinical Trials Llc — Anaheim, California, United States
• Study site — 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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.