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Testing two doses of resveratrol

Researchers compare two doses of a resveratrol product with an inactive treatment in people with Parkinson’s, with a focus on safety.

Testing a treatment or activity · Study reference: NCT07592767

Plain-language introduction written with AI from the registry; not independently checked by a clinician. Read the original details below ↓

Open the official registry record ↗

Who can join?

Ages 55 years to 85 years · Does not accept healthy volunteers

These are starting points, not the full rules. The research team can tell you whether the study is right for your situation.

Read all the rules for taking part

Sex eligibility reported by registry: all

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), corticobasal degeneration (CBD), supranuclear gaze palsy, multiple system atrophy (MSA), chronic traumatic encephalopathy (CTE), frontal dementia, history of stroke, head injury or encephalitis, cerebellar signs, early severe autonomic involvement * Any psychiatric diagnosis or symptoms, (e.g., hallucinations and suicidality, major depression, or delusions) that could interfere with study procedures * Medical history of liver or pancreatic disease, GI, ulcers and Chron's disease, kidney, or blood problems. Any other clinically significant abnormalities in physical examination, vital signs, laboratory tests, or ECG at Screening or Baseline. Any other medical conditions (e.g., cardiac, respiratory, GI, renal disease) which are not adequately controlled, or which in the opinion of the investigator(s) could affect the subject's safety or interfere with the study assessments and are below grade 3 criteria as outlined in table 2. * Enrolled as an active participant in another clinical study * Anti-coagulant medications, including Coumadin, heparin, enoxaparin, fondaparinux etc. * Any immunological disease which is not adequately controlled, or which requires treatment with immunoglobulins, systemic monoclonal antibodies (or derivatives of monoclonal antibodies), systemic immunosuppressant's, or plasmapheresis during the * Geriatric Depression Scale (GDS) score greater than or equal to 8 at Screening. * Answer "yes" to C-SSRS suicidal ideation Type 4 or 5, or any suicidal behavior assessment within 6 months before Screening, at Screening, or at the Baseline Visit, or has been hospitalized or treated for suicidal behavior in the past 5 years before Screening. * Planned surgery which requires general anesthesia that would take place during the study. * Severe visual or hearing impairment that would prevent the subject from performing psychometric tests accurately. * Women of Childbearing Potential (WCBP) or lactating. * Must not be on any nutritional or medicinal supplements at least 6 weeks prior to enrollment.
Full study name & original research details

Official study title

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

Short title used by the registry

RESvEraTrol in Parkinson's Disease (RESET)

Original description

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.

Further description from the registry

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, QD, for 3 months. Participants will be in the study for a total period of 4-5 months. Duration of Study: Enrollment will be (competitive) open for 1 year and total study duration is 2 years. Screening period: Consent and enrollment will take 4 weeks to determine eligibility and stabilize all participants on the standard of care (SOC). Eligible patients will be randomized into Arm A (Placebo), B (200mg JotrolTM) and C (400mg JotrolTM). Titration: Participants in Arm A will resume taking 4 placebo capsules from Week 1 through Participants in Arm B 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 in Arm C 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.

Conditions reported: Parkinson's Disease

Study type
Interventional
Interventions
Trans-Resveratrol
Phases
PHASE2
Sponsor
Georgetown University
Start date reported by registry
2026-09-17 (estimated)

Registry updated: 2026-09-18 · Status last verified by the registry submitter: 2026-05

Registry records retrieved 2026-10-11 (UTC). Individual records may have older updates. Recruitment and eligibility must be confirmed with the study team.

Contact the research team

Public study contacts supplied to the registry. Ask whether recruitment is still open and what participation involves.

Luke Lovelace, BS, MBA · 757-802-5001 · ll928@georgetown.edu

Michaeline Hebron, BA, MS · 570-677-4803 · mlh88@georgetown.edu

Study locations

Site status can differ from overall study status. “Status not reported” means local availability needs confirmation. Remote participation and travel arrangements must be checked with the team.

Georgetown University Hospital

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

Recruiting

Luke Lovelace · 757-802-5001 · ll928@georgetown.edu

Michaeline Hebron · mlh88@georgetown.edu

The original descriptions and participation rules come from the registry. Participation is voluntary and does not guarantee benefit.