RESvEraTrol in Parkinson's Disease (RESET)

NCT07592767 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: STUDY00009108
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (4)

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

  Evaluate the safety and tolerability of JotrolTM in individuals diagnosed with PD via Adverse Events (AEs) and Treatment Emergent AEs (TEAEs)

  12 weeks

• Incidence of abnormal Electrocardiogram (ECG) findings [Safety and Tolerability])

  Evaluate the safety and tolerability of JotrolTM in individuals diagnosed with PD via Electrocardiograms (ECG). ECGs with a QTc ≥500 ms and/or an increase of QTc ≥60 ms from baseline.

  Change from Baseline to Week-12

• Determination of Jotrol's safe and tolerable dose in plasma [Safety and Tolerability]

  Evaluate the PK of JotrolTM via measurement of its maximum concentration (Cmax) in plasma validated by the Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS) method

  Between 5 to 12 weeks

• Determination of Jotrol's safe and tolerable dose in Cerebral Spinal Fluid (CSF) [Safety and Tolerability]

  Evaluate the PK of JotrolTM via measurement of its maximum concentration (Cmax) in CSF validated by the Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS) method

  Between 5 to 12 weeks

Secondary Outcomes (3)

• Energy metabolism via blood levels of ATP

  Change from Baseline to Week-12

• Plasma biomarker analysis for the inflammatory profile

  Change from Baseline to Week-12

• Cerebral Spinal Fluid (CSF) biomarker analysis for the inflammatory profile

  Change from Baseline to Week-12

Other Outcomes (6)

• Alzheimer's Disease Assessment Scale-Cognitive Subscale 14 (ADAS-cog 14)

  Change from Baseline to Week-12

• Unified Parkinsons Disease Rating Scale Part 1, 2, and 3 (UPDRS 1, 2, and 3) (OFF)

  Change from Baseline to Week-12

• Montreal Cognitive Assessment (MoCA)

  Change from Baseline to Week-12

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Participants will resume taking 4 placebo capsules once a day from Week 1 through 12

Drug: Trans-Resveratrol

200mg JotrolTM

EXPERIMENTAL

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.

Drug: Trans-Resveratrol

400mg JotrolTM

EXPERIMENTAL

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.

Drug: Trans-Resveratrol

Interventions

Trans-Resveratrol DRUG

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.

Also known as: JOTROLTM, JNS115

200mg JotrolTM; 400mg JotrolTM; Placebo

Eligibility Criteria

• Age: 55 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Georgetown University: lead
• Jupiter Neuroscience Inc.: collaborator
• Medstar Health Research Institute: collaborator

MeSH Terms

Conditions

Parkinson Disease

Interventions

Resveratrol

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Stilbestrols; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polyphenols; Phenols

Study Officials

• Fernando Pagan, M.D.

  Georgetown University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Luke Lovelace, BS, MBA

CONTACT

757-802-5001; ll928@georgetown.edu

Michaeline Hebron, BA, MS

CONTACT

570-677-4803; mlh88@georgetown.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Movement Disorders Program

Study Record Dates

• First Submitted: May 1, 2026
• First Posted: May 18, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2029
• Last Updated: May 18, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share