RecruitingPhase 2NCT07592767

RESvEraTrol in Parkinson's Disease (RESET)

Multicenter, Randomized, Double Blind, Placebo-Controlled Phase 2a Study, to Evaluate Safety, Tolerability and Pharmacokinetics of Resveratrol (JOTROLTM) in Parkinson's Disease


Sponsor

Georgetown University

Enrollment

30 participants

Start Date

Sep 17, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 55 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Trans-Resveratrol for people with parkinson's disease. The study is currently recruiting participants at 1 location. People eligible for this study include aged 55 Years to 85 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTrans-Resveratrol

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.


Locations(1)

Georgetown University Hospital

Washington D.C., District of Columbia, United States

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NCT07592767


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