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:
Recruiting
Brief Description:
The purpose of this study is to evaluate the safety and pharmacodynamic effects of the experimental drug BMS-241027 (microtubule stabilizer) on levels of the protein tau in cerebrospinal fluid and on results of magnetic resonance imaging (MRI) and computerized cognitive tests in people with mild Alzheimer's disease. Participants will be given nine weekly intravenous infusions of BMS-241027 or a placebo treatment.
Patient Qualifications:
| Min Age | Max Age | Gender | Healthy Volunteers |
|---|---|---|---|
50 Years | 90 Years | Both | No |
Inclusion Criteria:
- Mild Alzheimer's disease
- Mini-Mental State Examination score between 20 and 26 (inclusive)
- Cerebrospinal fluid consistent with AD pathology
- Brain MRI that is normal and commensurate with age or that demonstrates shrinkage consistent with Alzheimer's diagnosis
- Reliable study partner
Exclusion Criteria:
- Medical condition other than mild Alzheimer's disease that could explain memory or cognitive deficits
- Diagnosis of moderate or severe Alzheimer's
- History of stroke or gastrointestinal illness
- 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
- Treatment for or have had diagnosis of schizophrenia or bipolar disease within past 3 years
- History of generalized peripheral neuropathy
Detailed Description:
None provided.
Central Contact Information:
For more information about this clinical trial or study sites, please contact Bristol-Myers Squibb at Clinical.Trials@bms.com. Reference NCT#01492374 and the site number in the chart below.
Locations:
| Map Marker | City | State | Zip Code | Status | Primary Contact | |
|---|---|---|---|---|---|---|
Geolocation is 32.2402988, -110.9454478 | Site 017 | Tucson | Arizona | 85724 | Not yet recruiting | |
Geolocation is 33.8469812, -117.9541894 | Site 026 | Anaheim | California | 92801 | Not yet recruiting | |
Geolocation is 33.7852683, -118.0273914 | Site 009 | Garden Grove | California | 92845 | Not yet recruiting | |
Geolocation is 37.7642093, -122.4571623 | Site 035 | San Francisco | California | 94143 | Not yet recruiting | |
Geolocation is 40.0454736, -105.2838511 | Site 034 | Boulder | Colorado | 80304 | Not yet recruiting | |
Geolocation is 41.063555241, -73.5368649 | Site 027 | Fairfield | Connecticut | 06430 | Not yet recruiting | |
Geolocation is 28.5085825, -81.3564411 | Compass Research | Orlando | Florida | 32806 | Recruiting | Craig T. Curtis 407-426-9299 |
Geolocation is 26.8233946, -80.1386547 | Site 024 | Palm Beach Gardens | Florida | 33418 | Not yet recruiting | |
Geolocation is 33.7980995, -84.3259367 | Site 013 | Atlanta | Georgia | 30322 | Not yet recruiting | |
Geolocation is 42.0039178, -87.9703461 | Site 032 | Elk Grove Village | Illinois | 60007 | Not yet recruiting | |
Geolocation is 42.7369792, -84.4838654 | Site 040 | East Lansing | Michigan | 48823 | Not yet recruiting | |
Geolocation is 40.74727, -73.9800645 | Site 043 | New York | New York | 10016 | Not yet recruiting | |
Geolocation is 39.9990626, -83.0173386 | Site 033 | Columbus | Ohio | 43210 | Not yet recruiting | |
Geolocation is 40.0959438, -75.1251743 | Site 015 | Jenkintown | Pennsylvania | 19046 | Not yet recruiting | |
Geolocation is 39.958358739, -75.1953934 | Site 029 | Philadelphia | Pennsylvania | 19104 | Not yet recruiting | |
Geolocation is 39.958358739, -75.1953934 | Site 041 | Philadelphia | Pennsylvania | 19104 | Not yet recruiting | |
Geolocation is 40.7078639, -111.8508966 | Site 003 | Salt Lake City | Utah | 84106 | Not yet recruiting | |
Geolocation is 42.9555117, -81.2257216 | Site 045 | London | Ontario | N6C 5J1 | Not yet recruiting | |
Geolocation is 43.7585342, -79.3535081 | Site 046 | Toronto | Ontario | M3B 2S7 | Not yet recruiting | |
Geolocation is 45.4808565, -73.4666522 | Site 047 | Greenfield Park | Quebec | J4V 2J2 | Not yet recruiting |
Lead Sponsor:
| Agency |
|---|
Bristol-Myers Squibb |
Collaborator Sponsor:
Facility Investigators:
| Name | Role | Affiliation |
|---|---|---|
Bristol-Myers Squibb | Study Director | Bristol-Myers Squibb |
Study Contact:
| Name | |
|---|---|
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:
December 2013
Disease Stage:
Early
Enrollment:
100
