RESvEraTrol in Parkinson's Disease (RESET) (RESET)
2026年9月16日 更新者：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.
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (推定)
30
段階
- フェーズ2
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Luke Lovelace, BS, MBA
- 電話番号：757-802-5001
- メール：ll928@georgetown.edu
研究連絡先のバックアップ
- 名前：Michaeline Hebron, BA, MS
- 電話番号：570-677-4803
- メール：mlh88@georgetown.edu
研究場所
-
-
District of Columbia
-
Washington D.C.、District of Columbia、アメリカ、20007
- 募集
- Georgetown University Hospital
-
コンタクト：
- Luke Lovelace
- 電話番号：757-802-5001
- メール：ll928@georgetown.edu
-
コンタクト：
- Michaeline Hebron
- メール：mlh88@georgetown.edu
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：他の
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
プラセボコンパレーター：Placebo
Participants will resume taking 4 placebo capsules once a day from Week 1 through 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.
他の名前：
|
|
実験的：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.
他の名前：
|
|
実験的：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.
他の名前：
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
時間枠：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])
時間枠：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]
時間枠：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]
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Energy metabolism via blood levels of ATP
時間枠：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
時間枠：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
時間枠：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
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Alzheimer's Disease Assessment Scale-Cognitive Subscale 14 (ADAS-cog 14)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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)
時間枠：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
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Fernando Pagan, M.D.、Georgetown University
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年9月17日
一次修了 (推定)
2028年6月1日
研究の完了 (推定)
2029年6月1日
試験登録日
最初に提出
2026年5月1日
QC基準を満たした最初の提出物
2026年5月11日
最初の投稿 (実際)
2026年5月18日
学習記録の更新
投稿された最後の更新 (実際)
2026年9月18日
QC基準を満たした最後の更新が送信されました
2026年9月16日
最終確認日
2026年5月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- STUDY00009108
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
IPD プランの説明
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.
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
はい
米国FDA規制機器製品の研究
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。