Evaluation of Tau-Pathology in Sporadic and LRRK2 Parkinson's Disease

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age45-85
SponsorMichael J. Fox Foundation for Parkinson's Research

About this trial

The study aims to evaluate the burden of tau pathology in people with Sporadic and LRRK2 PD via in vivo imaging using the tau tracer, \[18F\]PI-2620, and a high resolution PET camera, NeuroEXPLORER.

Eligibility criteria

Qualifiers

Ability to comply with the study procedures and attend follow-up visits.

Written informed consent from the participant or legal guardian.

Male or Female between 45 years and 85 years of age (Females must meet additional criteria specified below, as applicable) a. Females must be of non-childbearing potential or using a highly effective method of birth control 14 days prior to until at least 24 hours after injection of [18F]PI-2620 or DaTscan.

Diagnosis of progressive supranuclear palsy (PSP) based on the Clinical diagnosis of progressive supranuclear palsy: The movement disorder society criteria (Höglinger et al., 2017).

Disqualifiers

Any other medical or psychiatric condition or lab abnormality, which in the opinion of the investigator might preclude participation.

Received any of the following drugs: dopamine receptor blockers (neuroleptics), metoclopramide and reserpine, within 6 months of Screening Visit for non-PPMI participants or within 6 months of Baseline Visit for PPMI participants.

Any structural abnormality or finding on previously obtained or screening brain MRI suggestive of clinically significant neurological disorders other than the diseases of interest (in the opinion of the investigator).

Any other reason that in the opinion of the investigator, including abnormal labs, that could interfere with the safety with radiotracer injection, would render the participant unsuitable for the study enrollment.

Trial design

Treatments tested in this trial

  • [18F]PI-2620

Treatment groups

60 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Michael J. Fox Foundation for Parkinson's Research

Lead sponsor

Institute for Neurodegenerative Disorders

Collaborator