Alzheimer's Disease Clinical Trial
Official title:
A 54-week, Study to Investigate the Effects of Rosiglitazone (Extended Release Tablets) as Adjunctive Therapy to Acetylcholinesterase Inhibitors on Cognition and Overall Clinical Response in APOE e4-stratified Subjects With Mild to Moderate Alzheimer's Disease (REFLECT-3)
Rosiglitazone (RSG) has been tested in clinical studies and is approved by the FDA as a
treatment for type II diabetes mellitus, a disease that occurs when the body is unable to
effectively use glucose. RSG XR, the investigational drug used in this study, is an
extended-release form of RSG.
This study tests whether RSG XR safely provides clinical benefit to people with mild to
moderate Alzheimer's disease (AD) when combined with one of the currently approved AD
medications, Aricept®, Razadyne® or Exelon®. RSG XR is a new approach to AD therapy and this
study tests a new way to treat AD by testing whether one's genetic makeup affects the
response to the study drug. Clinical data suggesting that RSG may benefit AD patients was
first seen in a small study performed at the University of Washington and then from a larger
GSK study conducted in Europe and New Zealand. In the first study, subjects receiving RSG
once daily for 6 months scored significantly better on 3 tests of memory and thought than
those who did not receive RSG. In the GSK study, those that appeared to benefit most from
treatment with RSG XR had a specific genetic pattern. They did not have the gene that caused
them to produce the protein apolipoprotein E e4 (APOE e4). Subjects who have the APOE e4
gene may have two copies, one from each parent, or they may have only one APOE e4 gene
meaning that they inherited either the APOE e2 or APOE e3 version of the gene, instead of
APOE e4, from one of their parents. Subjects with one copy of the APOE e4 gene remained at
their same level of thinking ability while those with two copies of the APOE e4 gene,
continued to worsen during the 6-month treatment. The current study will more directly test
the effectiveness or RSG XR on people who either have or lack the APOE e4 gene.
A 54-week, double-blind, randomized, placebo-controlled, parallel-group study to investigate the effects of rosiglitazone (extended release tablets) as adjunctive therapy to acetylcholinesterase inhibitors on cognition and overall clinical response in APOE e4-stratified subjects with mild to moderate Alzheimer's disease (REFLECT-3) ;
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