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A Multi-Center, Double-Blind, Placebo-Controlled Phase II Study of Pioglitazone in Early Parkinson’s Disease (FS-ZONE).
The purpose of this study is to compare the effects, good and/or bad, of pioglitazone (Actos®) taken once daily. We will compare two doses of pioglitazone: 15 and 45 milligrams, with a placebo to find out how it effects the progression of PD over 44 weeks. Recent studies show that pioglitazone may help protect nerve cells in neurological disorders such as Parkinson’s disease. This study will evaluate whether pioglitazone is safe and well tolerated in patients with PD.
This study will also explore the effect of pioglitazone on cognitive function, mood, and biomarkers from samples of blood and urine. Biomarkers are biological characteristics or features that can provide information on how the disease changes over time and may be useful in developing new treatments and improving clinical care in the future.
*Study information also listed on ClinicalTrials.gov, here.