RESvEraTrol in Parkinson's Disease (RESET) (RESET)
2026년 9월 16일 업데이트: 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.
연구 개요
상세 설명
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.
연구 유형
중재적
등록 (추정된)
30
단계
- 2 단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Luke Lovelace, BS, MBA
- 전화번호: 757-802-5001
- 이메일: ll928@georgetown.edu
연구 연락처 백업
- 이름: Michaeline Hebron, BA, MS
- 전화번호: 570-677-4803
- 이메일: mlh88@georgetown.edu
연구 장소
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District of Columbia
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Washington D.C., District of Columbia, 미국, 20007
- 모병
- Georgetown University Hospital
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연락하다:
- Luke Lovelace
- 전화번호: 757-802-5001
- 이메일: ll928@georgetown.edu
-
연락하다:
- Michaeline Hebron
- 이메일: mlh88@georgetown.edu
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-
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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위약 비교기: Placebo
Participants will resume taking 4 placebo capsules once a day from Week 1 through 12
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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.
다른 이름들:
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실험적: 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.
|
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.
다른 이름들:
|
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실험적: 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.
|
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.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
기간: 12 weeks
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Evaluate the safety and tolerability of JotrolTM in individuals diagnosed with PD via Adverse Events (AEs) and Treatment Emergent AEs (TEAEs)
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12 weeks
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Incidence of abnormal Electrocardiogram (ECG) findings [Safety and Tolerability])
기간: Change from Baseline to Week-12
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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.
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Change from Baseline to Week-12
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Determination of Jotrol's safe and tolerable dose in plasma [Safety and Tolerability]
기간: Between 5 to 12 weeks
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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
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Between 5 to 12 weeks
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Determination of Jotrol's safe and tolerable dose in Cerebral Spinal Fluid (CSF) [Safety and Tolerability]
기간: Between 5 to 12 weeks
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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
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Between 5 to 12 weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Energy metabolism via blood levels of ATP
기간: Change from Baseline to Week-12
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Evaluate the effects of JotrolTM energy metabolism via blood levels of ATP
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Change from Baseline to Week-12
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Plasma biomarker analysis for the inflammatory profile
기간: Change from Baseline to Week-12
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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).
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Change from Baseline to Week-12
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Cerebral Spinal Fluid (CSF) biomarker analysis for the inflammatory profile
기간: Change from Baseline to Week-12
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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).
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Change from Baseline to Week-12
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Alzheimer's Disease Assessment Scale-Cognitive Subscale 14 (ADAS-cog 14)
기간: Change from Baseline to Week-12
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Evaluate the effects of JotrolTM on ADAS-cog 14 by measuring the change from Baseline to WK-12
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Change from Baseline to Week-12
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Unified Parkinsons Disease Rating Scale Part 1, 2, and 3 (UPDRS 1, 2, and 3) (OFF)
기간: Change from Baseline to Week-12
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Evaluate the effects of JotrolTM on UPDRS 1, 2, and 3 by measuring the change from Baseline to WK-12
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Change from Baseline to Week-12
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Montreal Cognitive Assessment (MoCA)
기간: Change from Baseline to Week-12
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Evaluate the effects of JotrolTM on MoCA by measuring the change from Baseline to WK-12
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Change from Baseline to Week-12
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Neuropsychiatric Inventory (NIP)
기간: Change from Baseline to Week-12
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Evaluate the effects of JotrolTM on NIP by measuring the change from Baseline to WK-12
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Change from Baseline to Week-12
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Parkinsons' disease questionnaire (PDQ)-39
기간: Change from Baseline to Week-12
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Evaluate the effects of JotrolTM on PDQ-39 by measuring the change from Baseline to WK-12
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Change from Baseline to Week-12
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Timed up and Go (TUG)
기간: Change from Baseline to Week-12
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Evaluate the effects of JotrolTM on TUG by measuring the change from Baseline to WK-12
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Change from Baseline to Week-12
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Fernando Pagan, M.D., Georgetown University
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 9월 17일
기본 완료 (추정된)
2028년 6월 1일
연구 완료 (추정된)
2029년 6월 1일
연구 등록 날짜
최초 제출
2026년 5월 1일
QC 기준을 충족하는 최초 제출
2026년 5월 11일
처음 게시됨 (실제)
2026년 5월 18일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 9월 18일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 9월 16일
마지막으로 확인됨
2026년 5월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- STUDY00009108
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
IPD 계획 설명
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.
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
예
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .