Rosiglitazone (Extended Release Tablets) As Adjunctive Therapy For Subjects With Mild To Moderate Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional

Summary: 
      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 the currently approved AD medication,
      Aricept (donepezil). 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 their 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.
    

Detailed description: 
      A 54-week, double-blind, randomized, placebo-controlled, parallel-group study to investigate
      the effects of rosiglitazone (extended release tablets) as adjunctive therapy to donepezil on
      cognition and overall clinical response in APOE e4-stratified subjects with mild to moderate
      Alzheimer's disease (REFLECT-2)
    

Intervention name(s): Rosiglitazone Extended Release 2mg; Rosiglitazone Extended Release 8mg; Placebo; Donepezil
Intervention type(s): Drug; Drug; Other; Other
Intervention description(s): Rosiglitazone Extended Release 2mg OD; Rosiglitazone Extended Release 8mg OD; Placebo; Donepezil (At least 6 months of ongoing donepezil therapy for Alzheimer's disease, with stable dosing for at least the last 2 months (and with no intent to change for the duration of the study).
Other intervention name(s): Aricept
Intervention MeSH terms: Rosiglitazone; Donepezil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: apolipoprotein E; Alzheimer's disease; cognition; rosiglitazone; adjunctive therapy