Resveratrol for Parkinson's Disease
(RESET Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Who Is on the Research Team?
Fernando Pagan, M.D.
Principal Investigator
Georgetown University
Are You a Good Fit for This Trial?
This trial is for people aged 55-85 with Parkinson's Disease (including those with mild dementia), who are medically stable, can speak English, and have been on a steady dose of their main Parkinson’s medications for at least 4 weeks.Inclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Trans-Resveratrol
Trial Overview
The study tests two different doses of an oral resveratrol product (JotrolTM) versus a placebo. Participants are randomly assigned to one of three groups and take the study drug once daily for 3 months to assess safety and how the body processes the drug.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Placebo Group
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 If the TEAE recurs in the same patient with a lower dose, the participant will be withdrawn from the study.
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.
Participants will resume taking 4 placebo capsules once a day from Week 1 through 12
Find a Clinic Near You
Who Is Running the Clinical Trial?
Georgetown University
Lead Sponsor
Medstar Health Research Institute
Collaborator
Jupiter Neuroscience Inc.
Collaborator
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