What is it and what does it include?
This phase II placebo-controlled, randomized, proof-of-concept clinical trial applied [¹⁸F]FDG-PET to evaluate the effects of rosiglitazone on functional brain activity and cognition in patients with mild to moderate Alzheimer's Disease (AD). In this study, investigators contrasted effects of 12 months treatment with the PPARγ agonist Rosiglitazone XR versus placebo in 80 mild to moderate AD patients across 14 centers in 3 countries (Canada, United Kingdom, and United States).
This Phase IIb study was a supportive study for the Phase III development program (Open-Label Extension Assessing Long-Term Safety Of Rosiglitazone In Subjects With Mild To Moderate Alzheimer's Disease) evaluating RSG in AD.
How can I use this dataset to advance my research?
This dataset is ideal if:
- you’re studying the effects of donepezil, rivastigmine, or galantamine and/or Rosiglitazone (Avandia) versus placebo on cerebral glucose metabolism or cognitive performance on patients with positive and negative APOE ε4 status.
- you’re studying the effects of a PPARγ agonist on functional brain activity and cognition in patients with mild to moderate Alzheimer's Disease (AD).
- you’re studying the ability of a PPARγ agonist to modify cerebral glucose uptake.
- you’re investigating volumetric changes in the brain in patients undergoing treatment with a PPARγ agonist and who had a diagnosis of probably AD.
Has this dataset helped researchers understand Alzheimer’s and other dementias better?
Of course!
- AD & Pharmacokinetics:
In 2011, researchers demonstrated the feasibility of using [18F]FDG-PET as part of a multi-center therapeutics trial. Specifically, their study suggested that Rosiglitazone, a PPARγ agonist, is associated with an early increase in whole brain glucose metabolism, but not with any biological or clinical evidence for slowing progression over a 1 year follow up in the symptomatic stages of AD. Their results point at future work using more CNS penetrant metabolic modulators, potentially applied in patients for longer periods and at even earlier stages in the disease. January 2011 – DOI: 10.3233/JAD-2010-100939