Recruiting
Phase 2

JotrolTM

Sponsor:

Georgetown University

Code:

NCT07592767

Conditions

Parkinson's Disease

Eligibility Criteria

Sex: All

Age: 55 - 70+

Healthy Volunteers: Not accepted

Interventions

Trans-Resveratrol

Study Details

Brief summary:

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.

Conditions

Parkinson's Disease

Study ID

NCT07592767

Start date

Sep 17, 2026

Status verified date

May, 2026

Completion date

Jun 1, 2029

Anticipated

Primary completion date

Jun 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 55 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

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.

Interventions

Trans-Resveratrol

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.

Primary outcome measure

  • Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [ Time Frame: 12 weeks ]
  • Incidence of abnormal Electrocardiogram (ECG) findings [Safety and Tolerability]) [ Time Frame: Change from Baseline to Week-12 ]
  • Determination of Jotrol's safe and tolerable dose in plasma [Safety and Tolerability] [ Time Frame: Between 5 to 12 weeks ]
  • Determination of Jotrol's safe and tolerable dose in Cerebral Spinal Fluid (CSF) [Safety and Tolerability] [ Time Frame: Between 5 to 12 weeks ]

Central Contacts and Locations

Central contacts

Luke Lovelace, BS, MBA

757-802-5001ll928@georgetown.edu

Michaeline Hebron, BA, MS

570-677-4803mlh88@georgetown.edu

Locations

Georgetown University Hospital

Recruiting

Washington D.C., District of Columbia, United States, 20007

Contacts

Luke Lovelace

757-802-5001ll928@georgetown.edu

Michaeline Hebron

mlh88@georgetown.edu

More Information

Sponsor

Georgetown University

Last update posted

Sep 18, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-23. This information was provided to ClinicalTrials.gov by Georgetown University on 2026-09-18.