Alzheimer's Disease Education and Referral Center

Effect of BMS-241027 on Cerebrospinal Fluid Biomarkers in Mild Alzheimer's Disease

Effect of BMS-241027 on Cerebrospinal Fluid Biomarkers in Mild Alzheimer's Disease

Overall Status: 
Completed
Brief Description: 

This Phase I clinical trial will evaluate the safety and pharmacodynamic effects of the experimental drug BMS-241027 in people with mild Alzheimer's disease.

Patient Qualifications: 
Min AgeMax AgeGenderHealthy Volunteers
50 Years
90 Years
Both
No
Inclusion Criteria: 
    • Mild Alzheimer's disease
    • Mini-Mental State Examination score of 20-26 inclusive
    • Cerebrospinal fluid laboratory results consistent with Alzheimer's pathology
    • Magnetic resonance brain imaging results showing atrophy consistent with Alzheimer's diagnosis; no more than mild white matter disease; up to two lacunar infarcts acceptable except in anterior thalamus, genu of internal capsule, or basal forebrain; no cortical infarcts; no more than four microbleeds; no focal asymmetric lobar atrophy or other findings suggesting primary cause of dementia other than Alzheimer's; no macrohemorrhages (>10 mm)
    • Reliable study partner
    • Non-childbearing potential
Exclusion Criteria: 
    • Medical condition other than mild Alzheimer's disease that could explain memory or cognitive deficits
    • History of stroke, gastrointestinal illness, or generalized peripheral neuropathy
    • Vitamin B12 or folate deficiency
    • Unstable cardiovascular, pulmonary, gastrointestinal, or hepatic disease within 30 days prior to screening
    • Active liver disease or history of hepatic intolerance
    • Geriatric Depression Scale score of ≥ 6 at screening
    • Diagnosis of or treatment for schizophrenia or bipolar disease within 3 years prior to screening
Detailed Description: 

Participants will receive one of three doses of BMS-241027 or a placebo for 9 weeks. Investigators will then assess the drug's effect on levels of the protein tau in cerebrospinal fluid, results of magnetic resonance brain imaging, and results of computerized cognitive tests. BMS-241027 will be given once a week as an intravenous infusion. BMS-241027, also known as Epothilone D, is a microtubule stabilizing agent that also has effects on tau protein in animal models of Alzheimer’s disease.

Central Contact Information: 

For information about U.S. sites, please call the telephone numbers in the chart below. For information about a site outside the United States, e-mail Clinical.Trials@bms.com. The first line of the e-mail must contain the clinical trials identifying number, NCT01492374, and the site number listed below. Only trial sites that are recruiting have contact information at this time.

Locations: 
Map Marker CityStateZip CodeStatusPrimary Contact

Geolocation is 33.8469812, -117.9541894

Site
Anaheim
California
92801
Name:
Phone:

Geolocation is 33.8065036, -118.1912538

Site
Long Beach
California
90806
Name:
Phone:

Geolocation is 37.7748363, -122.3872576

Site
San Francisco
California
94158
Name:
Phone:

Geolocation is 40.0454736, -105.2838511

Site
Boulder
Colorado
80304
Name:
Phone:

Geolocation is 41.1948222, -73.28833

Site
Fairfield
Connecticut
06824
Name:
Phone:

Geolocation is 28.5085825, -81.3564411

Site
Orlando
Florida
32806
Name:
Phone:

Geolocation is 26.8598894, -80.0870155

Site
Palm Beach Gardens
Florida
33410
Name:
Phone:

Geolocation is 42.0039178, -87.9703461

Site
Elk Grove Village
Illinois
60007
Name:
Phone:

Geolocation is 42.339904, -71.0898892

Site
Boston
Massachusetts
02115
Name:
Phone:

Geolocation is 42.7247832, -84.4832117

Site
East Lansing
Michigan
48824
Name:
Phone:

Geolocation is 39.9990626, -83.0173386

Site
Columbus
Ohio
43210
Name:
Phone:

Geolocation is 40.0959438, -75.1251743

Site
Jenkintown
Pennsylvania
19046
Name:
Phone:

Geolocation is 39.9583587, -75.1953934

Site
Philadelphia
Pennsylvania
19104
Name:
Phone:

Geolocation is 39.9583587, -75.1953934

Site
Philadelphia
Pennsylvania
19104
Name:
Phone:

Geolocation is 40.7078639, -111.8508966

Site
Salt Lake City
Utah
84106
Name:
Phone:

Geolocation is 42.9555117, -81.2257216

Site
London
Ontario
N6C 5J1
Name:
Phone:

Geolocation is 43.7585342, -79.3535081

Site
Toronto
Ontario
M3B 2S7
Name:
Phone:

Geolocation is 45.4808565, -73.4666522

Site
Greenfield Park
Quebec
J4V 2J2
Name:
Phone:
Lead Sponsor: 
Agency
Bristol-Myers Squibb
Collaborator Sponsor: 
Facility Investigators: 
NameRoleAffiliation
Bristol-Myers Squibb
Study Director
Bristol-Myers Squibb
Study Contact: 
NameEmail
Bristol-Myers Squibb
Locations
 
 
ClinicalTrials.gov ID 
NCT01492374 (follow link to view full record on ct.gov in new window)
Official 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
Study Start Date: 
February 2012
Study End Date: 
October 2014
Disease Stage: 
Early
Enrollment: 
100