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

16 września 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Rekrutacyjny

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

30

Faza

  • Faza 2

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Kopia zapasowa kontaktu do badania

Lokalizacje studiów

  • Stany Zjednoczone
    • District of Columbia
      • Washington D.C., District of Columbia, Stany Zjednoczone, 20007

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Inny
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Poczwórny

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Komparator placebo: Placebo
Participants will resume taking 4 placebo capsules once a day from Week 1 through 12
Lek: 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.
Inne nazwy:
  • JOTROLTM
  • JNS115
Eksperymentalny: 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.
Lek: 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.
Inne nazwy:
  • JOTROLTM
  • JNS115
Eksperymentalny: 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.
Lek: 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.
Inne nazwy:
  • JOTROLTM
  • JNS115

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Ramy czasowe: 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])
Ramy czasowe: 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]
Ramy czasowe: 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]
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Energy metabolism via blood levels of ATP
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Inne miary wyników

Miara wyniku
Opis środka
Ramy czasowe
Alzheimer's Disease Assessment Scale-Cognitive Subscale 14 (ADAS-cog 14)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Georgetown University

Współpracownicy

Medstar Health Research Institute
Jupiter Neuroscience Inc.

Śledczy

  • Główny śledczy: Fernando Pagan, M.D., Georgetown University

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

17 września 2026

Zakończenie podstawowe (Szacowany)

1 czerwca 2028

Ukończenie studiów (Szacowany)

1 czerwca 2029

Daty rejestracji na studia

Pierwszy przesłany

1 maja 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

11 maja 2026

Pierwszy wysłany (Rzeczywisty)

18 maja 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

18 września 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

16 września 2026

Ostatnia weryfikacja

1 maja 2026

Więcej informacji

Terminy związane z tym badaniem

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • STUDY00009108

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Opis planu 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.

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Tak

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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