Status:
COMPLETED
Rosiglitazone (Extended Release Tablets) As Monotherapy In Subjects With Mild To Moderate Alzheimer's Disease
Lead Sponsor:
GlaxoSmithKline
Conditions:
Alzheimer's Disease
Eligibility:
All Genders
50-90 years
Phase:
PHASE3
Brief Summary
Rosiglitazone (RSG) has been tested and is approved as a treatment for type II diabetes mellitus, a disease that occurs when the body ineffectively uses glucose. RSG XR, the investigational drug, is a...
Detailed Description
A 24-week, double-blind, double-dummy, randomized, parallel-group study to investigate the effects of rosiglitazone (extended release tablets), donepezil, and placebo as monotherapy on cognition and o...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Clinical diagnosis of probable Alzheimer's Disease (AD).
- MMSE score 10 to 23
- Has not taken an approved AD therapy in last 30 days.
- No previous hypersensitivity/intolerance to AChEIs
- Have a regular caregiver.
- Exclusion criteria:
- Diagnosis of vascular dementia.
- Type I or secondary diabetes mellitus.
- Type II diabetes mellitus treated with insulin, sulfonylurea or glipizide.
- History or evidence of congestive heart failure, clinically significant peripheral edema or anemia.
- History of significant psychiatric illness, major depressive disorder or current depression needing initiation of treatment.
Exclusion
Key Trial Info
Start Date :
February 27 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 5 2008
Estimated Enrollment :
862 Patients enrolled
Trial Details
Trial ID
NCT00428090
Start Date
February 27 2007
End Date
September 5 2008
Last Update
May 19 2017
Active Locations (138)
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1
GSK Investigational Site
Phoenix, Arizona, United States, 85004
2
GSK Investigational Site
Los Angeles, California, United States, 90036
3
GSK Investigational Site
Newport Beach, California, United States, 92660
4
GSK Investigational Site
Palo Alto, California, United States, 94305