An Open-label Extension to Study AVA102670 and AVA102672, to Assess the Long-term Safety and Efficacy of Rosiglitazone (Extended Release Tablets) as Adjunctive Therapy on Cognition in Subjects With Mild to Moderate Alzheimer's Disease.
An Open-label Extension to Study AVA102670 and AVA102672, to Assess the Long-term Safety and Efficacy of Rosiglitazone (Extended Release Tablets) as Adjunctive Therapy on Cognition in Subjects With Mild to Moderate Alzheimer's Disease.
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.
Inclusion criteria:
Exclusion criteria:
Ciudad Autónoma de Buenos Aires, Buenos Aires C1192AAW, Argentina
Ciudad Autónoma de Buenos Aires, Buenos Aires C1419HDN, Argentina
Ciudad de Buenos Aires, Buenos Aires C1431FWO, Argentina
Providencia / Santiago, Región Metro de Santiago 7500710, Chile
San Felice A Cancello Caserta, Campania 81027, Italy
Torrette (AN), The Marches 60020, Italy
Loeventstein, 7530, South Africa
Waverley, Bloemfontein, 9301, South Africa
Willows, X14, Pretoria, 0040, South Africa