Georgetown University
This is an exploratory phase 2a study to investigate two doses of resveratrol (JotrolTM) vs placebo in individuals diagnosed with Parkinson's Disease (PD). Participants (n=30) will be randomized 1:1:1 into 3 groups and will receive oral JotrolTM vs placebo. Study drug will be titrated to reach a final maximal dose per group and will be administered orally once daily (QD) for 3 months. The study will primarily evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics (PK/PD) of JotrolTM.
Core Study. JotrolTM in subjects with PD is a 3-month treatment (Core Study). A total of 30 subjects will be randomized 1:1:1 across JotrolTM, 200mg or 400mg versus placebo. Biomarker Sub-study (Optional). There will be an additional sub-study, including cerebrospinal fluid (CSF) biomarkers assessments. Participation in this sub study is optional and will require specific consent that will not affect enrollment or treatment in the Core Study. Number of Centers: Approximately 3 centers US-Wide Duration of Treatment: Participants will take the study drug (JotrolTM or matching placebo) orally,…
Inclusion Criteria: * Capable of providing informed consent (IC) and complying with study procedures * Stable on Levodopa and/or DA agonists for at least 4 weeks before enrollment * Clinical diagnosis of PD according to UK Brain Bank criteria and/or PD with Dementia (PDD) by MDS criteria (53-55). * MoCA≥18. * Hohn and Yahr stage 2 and 3 * Age of 55-85 years, medically stable * English Fluency Exclusion Criteria: * Known PD-linked gene mutations e.g. PINK-1, DJ-1, parkin, LRRK2 etc. * Clinical signs indicating syndromes or disorders other than PD including, Alzheimer's Disease (AD), corticob…
Resveratrol (RSV) - or Trans-resveratrol- is polyphenolic compound in many plants, including grape, peanut, and berries. Biologically, RSV is a Sirtuin (SIRT) 1 activator that stimulates mitochondrial biogenesis; and regulates mitochondrial dynamics via autophagy (referred to as mitophagy). RSV plays a role in parkin-related mitophagy, which is necessary for mitochondrial dynamics but it is deficient in neurodegenerative diseases, including PD. RSV inhibits the activation of the NLRP3 (nucleotide-binding domain, leucine-rich repeat, and pyrin domain-containing protein 3) inflammasome, thereby lowering inflammation. The parallel roles of RSV to inhibit the NLRP3 inflammasome, increase autophagy and maintain mitochondrial integrity indicate that RSV is a therapeutic candidate that has strong neuroprotective effects via autophagy and inhibition of the NLRP3 inflammasome.
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