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| Sponsored by: |
GlaxoSmithKline |
|---|---|
| Information provided by: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00490568 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Mild-to-Moderate Alzheimers Disease |
Drug: Rosiglitazone XR |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | 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 Alzheimers Disease (REFLECT-4). |
| Enrollment: | 1517 |
| Study Start Date: | August 2007 |
| Study Completion Date: | April 2009 |
| Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Arm 1: Experimental |
Drug: Rosiglitazone XR
Experimental drug
|
Eligibility| Ages Eligible for Study: | 51 Years to 91 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion criteria:
SAE, clinically significant laboratory abnormality or significant cardiovascular event during prior study.
Contacts and Locations
Show 272 Study Locations| Study Director: | GSK Clinical Trials | GlaxoSmithKline |
More Information
| Responsible Party: | GSK ( Study Director ) |
| Study ID Numbers: | AVA102675 |
| Study First Received: | June 21, 2007 |
| Last Updated: | April 24, 2009 |
| ClinicalTrials.gov Identifier: | NCT00490568 History of Changes |
| Health Authority: | United States: Food and Drug Administration; United States: Food and Drug Administration |
|
Rosiglitazone extended-release (XR) BRL-049653 Alzheimer's disease adjunctive therapy |
cognition safety tolerability open-label extension |
|
Neurotransmitter Agents Alzheimer Disease Central Nervous System Diseases Brain Diseases Neurodegenerative Diseases Cholinergic Agents Cognition Disorders |
Cholinesterase Inhibitors Hypoglycemic Agents Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Dementia Rosiglitazone Delirium |
|
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Alzheimer Disease Nervous System Diseases Central Nervous System Diseases Enzyme Inhibitors Cholinergic Agents Brain Diseases |
Neurodegenerative Diseases Pharmacologic Actions Cholinesterase Inhibitors Hypoglycemic Agents Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Dementia Tauopathies Rosiglitazone |
