Open-Label Extension Study Of Rosiglitazone XR As Adjunctive Therapy In Subjects With Mild-to-Moderate Alzheimers
Status: | Terminated |
---|---|
Conditions: | Alzheimer Disease |
Therapuetic Areas: | Neurology |
Healthy: | No |
Age Range: | 51 - 91 |
Updated: | 10/14/2017 |
Start Date: | August 2007 |
End Date: | June 2009 |
An Open-label Extension Study of the Long-term Safety and Efficacy of Rosiglitazone Extended-release (RSG XR) as Adjunctive Therapy to Acetylcholinesterase Inhibitors in Subjects With Mild-to-moderate Alzheimer's Disease (REFLECT-4).
This is a Phase III, multicenter, open-label extension, single-group study in male and female
outpatients with mild-to-moderate Alzheimer's disease (AD) who have completed either
AVA102670 or AVA102672. All subjects will receive rosiglitazone extended-release (RSG XR) 4mg
once daily for the first 4 weeks of the study followed by 8mg RSG XR as adjunctive therapy to
their existing dose of acetylcholinesterase inhibitor. Subject participation will last until
one of 5 conditions applies. After a 52-week open-label treatment phase, subjects will attend
a final Follow-Up Visit 6 weeks after the end of treatment. The primary objective of this
study is to evaluate the long-term safety and tolerability of RSG XR in subjects with
mild-to-moderate AD who have completed either AVA102670 or AVA102672. The secondary objective
of this study is to explore further the long-term efficacy of RSG XR in terms of cognitive
function and overall clinical response as a function of apolipoprotein E (APOE) e4 allele
status.
outpatients with mild-to-moderate Alzheimer's disease (AD) who have completed either
AVA102670 or AVA102672. All subjects will receive rosiglitazone extended-release (RSG XR) 4mg
once daily for the first 4 weeks of the study followed by 8mg RSG XR as adjunctive therapy to
their existing dose of acetylcholinesterase inhibitor. Subject participation will last until
one of 5 conditions applies. After a 52-week open-label treatment phase, subjects will attend
a final Follow-Up Visit 6 weeks after the end of treatment. The primary objective of this
study is to evaluate the long-term safety and tolerability of RSG XR in subjects with
mild-to-moderate AD who have completed either AVA102670 or AVA102672. The secondary objective
of this study is to explore further the long-term efficacy of RSG XR in terms of cognitive
function and overall clinical response as a function of apolipoprotein E (APOE) e4 allele
status.
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. SAE, clinically
significant laboratory abnormality or significant cardiovascular event during prior
study.
We found this trial at
42
sites
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