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NCT00348309 · ClinicalTrials.gov registry record · NA
Rosiglitazone (Extended Release Tablets) As Adjunctive Therapy For Subjects With Mild To Moderate Alzheimer's Disease
A NA study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- NA
- Development phase
- 1,496
- Enrollment target
NCT00348309 is a NA study that has completed, run by GlaxoSmithKline. The registered enrollment target is 1,496 participants.
The verdict
NCT00348309, a NA study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- NA
- Development phase
- 1,496 participants
- Enrollment target
Study 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.
Interventions
- OTHER Placebo
- OTHER Donepezil
- DRUG Rosiglitazone Extended Release 2mg
- DRUG Rosiglitazone Extended Release 8mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,496 participants |
| Start Date | 2006-07-06 |
| Est. Completion | 2009-01-28 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00348309
The ClinicalTrials.gov registry entry for NCT00348309 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 1,496 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT00348309 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00348309 about?
NCT00348309 is a clinical study titled "Rosiglitazone (Extended Release Tablets) As Adjunctive Therapy For Subjects With Mild To Moderate Alzheimer's Disease". 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 st...
What is the current status of trial NCT00348309?
This trial is currently completed. It is a NA study. The enrollment target is 1,496 participants. The study started on 2006-07-06. Estimated completion is 2009-01-28.
What interventions are being tested in trial NCT00348309?
The interventions under investigation include: Placebo (OTHER), Donepezil (OTHER), Rosiglitazone Extended Release 2mg (DRUG), Rosiglitazone Extended Release 8mg (DRUG).
Who is sponsoring clinical trial NCT00348309?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
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