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
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 55 Years to 85 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Time periods mentioned: 3 months, 1 year
- Procedures mentioned: Pills
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "Study drug will be titrated to reach a final maximal dose per group and will be administered orally once daily (QD) for 3 months."
- "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."
- "Duration of Study: Enrollment will be (competitive) open for 1 year and total study duration is 2 years."
- "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."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests two doses of resveratrol (Jotrol) against a placebo, a pill with no study drug, in adults ages 55–85 with Parkinson’s disease. Participants take pills once a day for 3 months. The study checks safety, side effects, how the body handles the drug, and its effects on the body.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Can give informed consent and follow study steps.
- Have been on a stable dose of levodopa and/or dopamine agonists, medicines for Parkinson’s, for at least 4 weeks.
- Have a confirmed diagnosis of Parkinson’s disease, with or without dementia, under the study’s rules.
- Score at least 18 on the MoCA, a test of memory and thinking.
- Have stage 2 or 3 Parkinson’s on the Hoehn and Yahr scale.
- Are 55–85 years old and medically stable.
- Speak English fluently.
Who can't join
- Have a known gene change linked to Parkinson’s, or signs of another brain or nerve disorder. A history of stroke, head injury, or brain inflammation also excludes you.
- Have mental health symptoms that could disrupt the study, or score 8 or higher on the Geriatric Depression Scale. Certain suicidal thoughts or actions in the past 6 months, or treatment or hospital care for suicidal behavior in the past 5 years, also exclude you.
- Have a history of liver, pancreas, stomach, bowel, kidney, or blood problems; important abnormal exam or test results; or other health problems that could affect safety or study tests.
- Have an immune system disease that is not well controlled or needs certain treatments that affect the immune system.
- Are taking blood-thinning medicines, or have taken nutritional or medicinal supplements within 6 weeks before joining.
- Are actively taking part in another clinical study, or plan surgery during this study that requires medicine to put you fully asleep.
- Have severe trouble seeing or hearing that would prevent accurate memory and thinking tests.
- Are a woman who could become pregnant, or are breastfeeding.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
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.
Study sites (1)
DC
- Georgetown University Hospital · Washington D.C., DC 20007Luke Lovelace · Study contact · 757-802-5001 · ll928@georgetown.eduMichaeline Hebron · Study contact · mlh88@georgetown.eduMore trials in Washington D.C.