RESvEraTrol in Parkinson's Disease (RESET)

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age55-85
SponsorGeorgetown University

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Trans-Resveratrol

Treatment groups

30 Participants
are divided into 3 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

Georgetown University

Lead sponsor

Jupiter Neuroscience Inc.

Collaborator

Medstar Health Research Institute

Collaborator