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RESvEraTrol in Parkinson's Disease (RESET) (RESET)

11 maggio 2026 aggiornato da: Fernando Pagan MD, Georgetown University

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

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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

30

Fase

  • Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Altro
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Quadruplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore placebo: Placebo
Participants will resume taking 4 placebo capsules once a day from Week 1 through 12
Droga: 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.
Altri nomi:
  • JOTROLTM
  • JNS115
Sperimentale: 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.
Droga: 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.
Altri nomi:
  • JOTROLTM
  • JNS115
Sperimentale: 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.
Droga: 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.
Altri nomi:
  • JOTROLTM
  • JNS115

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Lasso di tempo: 12 weeks
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])
Lasso di tempo: Change from Baseline to Week-12
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]
Lasso di tempo: Between 5 to 12 weeks
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]
Lasso di tempo: Between 5 to 12 weeks
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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Energy metabolism via blood levels of ATP
Lasso di tempo: Change from Baseline to Week-12
Evaluate the effects of JotrolTM energy metabolism via blood levels of ATP
Change from Baseline to Week-12
Plasma biomarker analysis for the inflammatory profile
Lasso di tempo: Change from Baseline to Week-12
Evaluate the effects of JotrolTM in plasma on markers of inflammation, including but not limited to Triggering Receptor Expressed on Myeloid Cells (TREM)-2, matrix metalloproteases (MMPs) interleukins (IL)- 1α&β, 2, 3, 4, 5, 6, 7, 8 , 9, 10, 12, 13, 15, 17 α, chemokines (e.g. CXCL10, CCL2, CL7, CCL22, CCL3, CCL4), platelet-derived growth factor (PDGF)-AA, PDGF-AB/BB, CCL5, CX3CL1, Tumor necrosis growth factor (TNF)-α, transforming growth factor (TGF)-α, and vascular endothelial growth factor (VEGF), neurofilaments, glial fibrillary acidic protein (GFAP).
Change from Baseline to Week-12
Cerebral Spinal Fluid (CSF) biomarker analysis for the inflammatory profile
Lasso di tempo: Change from Baseline to Week-12
Evaluate the effects of JotrolTM in CSF on markers of inflammation, including but not limited to Triggering Receptor Expressed on Myeloid Cells (TREM)-2, matrix metalloproteases (MMPs) interleukins (IL)- 1α&β, 2, 3, 4, 5, 6, 7, 8 , 9, 10, 12, 13, 15, 17 α, chemokines (e.g. CXCL10, CCL2, CL7, CCL22, CCL3, CCL4), platelet-derived growth factor (PDGF)-AA, PDGF-AB/BB, CCL5, CX3CL1, Tumor necrosis growth factor (TNF)-α, transforming growth factor (TGF)-α, and vascular endothelial growth factor (VEGF), neurofilaments, glial fibrillary acidic protein (GFAP).
Change from Baseline to Week-12

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Alzheimer's Disease Assessment Scale-Cognitive Subscale 14 (ADAS-cog 14)
Lasso di tempo: Change from Baseline to Week-12
Evaluate the effects of JotrolTM on ADAS-cog 14 by measuring the change from Baseline to WK-12
Change from Baseline to Week-12
Unified Parkinsons Disease Rating Scale Part 1, 2, and 3 (UPDRS 1, 2, and 3) (OFF)
Lasso di tempo: Change from Baseline to Week-12
Evaluate the effects of JotrolTM on UPDRS 1, 2, and 3 by measuring the change from Baseline to WK-12
Change from Baseline to Week-12
Montreal Cognitive Assessment (MoCA)
Lasso di tempo: Change from Baseline to Week-12
Evaluate the effects of JotrolTM on MoCA by measuring the change from Baseline to WK-12
Change from Baseline to Week-12
Neuropsychiatric Inventory (NIP)
Lasso di tempo: Change from Baseline to Week-12
Evaluate the effects of JotrolTM on NIP by measuring the change from Baseline to WK-12
Change from Baseline to Week-12
Parkinsons' disease questionnaire (PDQ)-39
Lasso di tempo: Change from Baseline to Week-12
Evaluate the effects of JotrolTM on PDQ-39 by measuring the change from Baseline to WK-12
Change from Baseline to Week-12
Timed up and Go (TUG)
Lasso di tempo: Change from Baseline to Week-12
Evaluate the effects of JotrolTM on TUG by measuring the change from Baseline to WK-12
Change from Baseline to Week-12

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Georgetown University

Collaboratori

Medstar Health Research Institute
Jupiter Neuroscience Inc.

Investigatori

  • Investigatore principale: Fernando Pagan, M.D., Georgetown University

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 giugno 2026

Completamento primario (Stimato)

1 giugno 2028

Completamento dello studio (Stimato)

1 giugno 2029

Date di iscrizione allo studio

Primo inviato

1 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

11 maggio 2026

Primo Inserito (Effettivo)

18 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

18 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

11 maggio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • STUDY00009108

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

Data collected in this study will be presented using summary tables, participant data listings, and figures. Continuous variables will be summarized using descriptive statistics, specifically the mean, median, standard deviation, minimum, and maximum (and geometric means and coefficient of variation for the PK parameters). Frequencies and percentages will summarize categorical variables.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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