AVA102675 : Open-Label Extension Study Of Rosiglitazone XR As Adjunctive Therapy In Subjects With Mild-to-Moderate Alzheimers
Phase 3
- Conditions
- Health Condition 1: null- Alzheimers Dementia
- Registration Number
- CTRI/2009/091/000497
- Lead Sponsor
- GlaxoSmithKline Pharmaceuticals Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other (Terminated)
- Sex
- Not specified
- Target Recruitment
- 1800
Inclusion Criteria
Successful completion of AVA102670 or AVA102672 without safety or tolerability issues. Regular caregiver.
Exclusion Criteria
Congestive Heart Failure (NYHA 1-4), clinically significant peripheral edema, other neurological conditions that might disqualify participation.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence and severity of Adverse Events.Timepoint: Time Frame: 52 weeks
- Secondary Outcome Measures
Name Time Method ADAS-cog, CDR-SB, MMSE, DAD and NPI total scores as a function of APOE e4 status. Incidence and severity of SAEs, percentage of subjects with edema, change from baseline in vital signs, weight, non-fasting measures of lipid metabolism.Timepoint: Time Frame: 52 weeks