RESvEraTrol in Parkinson's Disease (RESET)

Sponsor
Georgetown University
Study ID
NCT07592767
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
55 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Trans-Resveratrol — DRUG
    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.

Study Details

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.

Key Dates

First listed
May 18, 2026
Start date
Jun 1, 2026
Status verified
May 2026
Primary completion
Jun 1, 2028
Completion
Jun 1, 2029

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Placebo Comparator: Placebo
    Participants will resume taking 4 placebo capsules once a day from Week 1 through 12
  • Experimental: 200mg JotrolTM
    In the first month, study drug will be titrated in multiple ascending doses. Participants will receive a single daily dose of 100mg JotrolTM in Week 1, and this dose will be escalated to 200mg at Week 2. If no Treatment Emergent Adverse Event (TEAE) is observed, participants will continue treatment with 200mg until week-12.
  • Experimental: 400mg JotrolTM
    In the first month, study drug will be titrated in multiple ascending doses. Participants will receive a single daily dose of 100mg JotrolTM in week-1, and this dose will increase to 200mg JotrolTM at week-2, and 300mg at week-3 and 400mg at Week 4. If no TEAEs are observed, participants will continue 400mg JotrolTM through Week 12. If any TEAE is observed during the titration period, participants will receive the prior (reduced) dose and continue the study until week-12. If the TEAE recurs in the same patient with a lower dose, the participant will be withdrawn from the study.

Primary Outcome Measure

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [ Time Frame: 12 weeks ]

Central Contacts

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