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Home » Clinical Trials » Alzheimer's Disease

Clinical Trial Details

Overview

Research Study Summary

Patients are needed to participate in a clinical research study evaluating BMS-241027 and Placebo matching BMS-241027 for the treatment of Alzheimer's Disease

Research Study Title

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

Purpose

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

To Learn more
Phase

1

Gender

Both Male and Female

Age

50 to 90 Years

Overall Status

Recruiting

Lead Sponsor

Bristol-Myers Squibb

Duration

32 Months

Facility Type

N/A

Eligibility

Both Male and Female ages 50 Years to 90 Years

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

Site Locations (22)

Country State City Zip Facility and Contact
United States California Garden Grove 90806 Collaborative Neuroscience Network, Inc.
Omid Omidvar, Site 009
714-799-7799
United States California San Francisco 94158 Ucsf Memory And Aging Center
Adam Boxer, Site 035
United States Colorado Boulder 80304 Alpine Clinical Research Center, Inc.
Paul Brownstone, Site 034
303-443-7229 ext. 101
United States Connecticut Fairfield 06824 Associated Neurologists Of Southern Connecticut, P.C.
Peter Mcallister, Site 027
United States Florida Orlando 32806 Compass Research, Llc
Craig T Curtis, Site 025
407-426-9299
United States Florida Palm Beach Gardens 33410 Palm Beach Neurological Center Advanced Research Consultants
Michael M Tuchman, Site 024
United States Illinois Elk Grove Village 60007 Alexian Brothers Neurosciences Institute Clinical Research
Concetta Forchetti, Site 032
847-228-6646
United States Massachusetts Boston 02115 Brigham And Women'S Hospital
Scott Mcginnis, Site 049
617-732-6984
United States Michigan Lansing 48824 Michigan State University
Andrea C Bozoki, Site 040
517-364-5591
United States Ohio Columbus 43210 The Ohio State University
Douglas W Scharre, Site 033
United States Pennsylvania Jenkintown 19046 The Clinical Trial Center, Llc
Marvin Kalafer, Site 015
215-884-1700
United States Pennsylvania Philadelphia 19104 Penn Memory Center
Steven Arnold, Site 041
United States Pennsylvania Philadelphia 19104 Hospital Of The University Of Pennsylvania
Murray Grossman, Site 029
215-662-3460
United States Utah Salt Lake City 84106 Lifetree Clinical Research
Miroslav Backonja, Site 003
801-269-8200
Canada Ontario London N6C 5J1 Local Institution
Site 045
Canada Ontario Toronto M3B 2S7 Local Institution
Site 046
Canada Quebec Greenfield Park J4V 2J2 Local Institution
Site 047
France Lille Cedex 59037 Local Institution
Site 030
France Toulouse Cedex 09 31059 Local Institution
Site 022
Germany Berlin 14050 Local Institution
Site 039
Germany Heidelberg 69115 Local Institution
Site 038
Sweden Stockholm 141 86 Local Institution
Site 023

Contact

For participation information at a USA site use a phone number below. For site information outside the USA please email:

If you would like to learn more about participating in this research study, please email the trial contact using the form below.

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NCT ID: NCT01492374

Date Last Changed: October 1, 2013

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