Rosiglitazone (Extended Release Tablets) As Monotherapy In Subjects With Mild To Moderate Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Intervention: Rosiglitazone
Intervention description: XR (extended release) oral tablets
Intervention MeSH terms: Rosiglitazone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 862.0
Sex: All
Minimum age: 50 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: apolipoprotein E; monotherapy; cognition; mild; rosiglitazone; Alzheimer's disease; moderate

Summary:

      Rosiglitazone (RSG) has been tested and is approved as a treatment for type II diabetes
      mellitus, a disease that occurs when the body ineffectively uses glucose. RSG XR, the
      investigational drug, is an extended-release form of RSG. This study tests whether RSG XR
      safely provides benefit to people with mild to moderate Alzheimer's disease (AD). RSG XR is a
      new approach to AD therapy and this study tests whether one's genes alter the effectiveness
      of RSG XR. Glucose is used by cells to make energy that they need to live. Changes in the
      ability of cells to use of glucose can lead to diseases like diabetes. Glucose levels may be
      lower in the brains of AD patients, and their brain cells may also use glucose less well than
      in unaffected people. The proper function of brain cells may be critical to memory and
      thought. If brain cells use glucose poorly, this might impact AD. Drugs that help brain cells
      properly use glucose may help a person maintain normal memory and thinking. Data suggesting
      that RSG may help AD patients was first seen in a small study at the Univ. of Washington and
      then from a larger international GSK study. In the first study, those receiving RSG once
      daily for 6 months scored better on 3 tests of memory and thought than those who did not
      receive RSG. In the GSK study, those that benefited most from therapy with RSG XR had a
      specific genetic pattern. They lacked the gene that caused them to produce 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 from one parent. Subjects with one copy of the APOE e4 gene remained
      fairly stable while those with two copies of APOE e4 continued to worsen during the 6-month
      treatment. This study will directly test the effect of RSG XR on people who either have or
      lack the APOE e4 gene.
    

Eligibility criteria:

        Inclusion criteria:

          -  Clinical diagnosis of probable Alzheimer's Disease (AD).

          -  MMSE score 10 to 23

          -  Has not taken an approved AD therapy in last 30 days.

          -  No previous hypersensitivity/intolerance to AChEIs

          -  Have a regular caregiver.

        Exclusion criteria:

          -  Diagnosis of vascular dementia.

          -  Type I or secondary diabetes mellitus.

          -  Type II diabetes mellitus treated with insulin, sulfonylurea or glipizide.

          -  History or evidence of congestive heart failure, clinically significant peripheral
             edema or anemia.

          -  History of significant psychiatric illness, major depressive disorder or current
             depression needing initiation of treatment.