NCT07592767RecruitingPhase 2
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
Source: ClinicalTrials.gov · Last updated 18 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 1 May 2026
- Start date
- 17 Sept 2026
- Primary completion date
- 1 Jun 2028
- Lead sponsor
- Georgetown University
- Diseases
- Parkinson disease
- NCT number
- NCT07592767
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 30
- From 17 Sept 2026 to the primary completion date, 1 Jun 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- 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.
- Must not be on any nutritional or medicinal supplements at least 6 weeks prior to enrollment.
Other illness
- 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
- Severe visual or hearing impairment that would prevent the subject from performing psychometric tests accurately.
Lab values
- 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.
Other
- Known PD-linked gene mutations e.g. PINK-1, DJ-1, parkin, LRRK2 etc.
- Enrolled as an active participant in another clinical study
- Geriatric Depression Scale (GDS) score greater than or equal to 8 at Screening.
- Women of Childbearing Potential (WCBP) or lactating.
Who the study is looking for
- 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
Age in the registry: 55 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Georgetown University Hospital Coordinator of this site? Confirm its status | Washington D.C. | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.