RECRUITING

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

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Evaluation of Tau-Pathology in Sporadic and LRRK2 Parkinson's Disease Using [18F]PI-2620: A High-resolution PET Imaging Study Using NeuroEXPLORER (NX PI-2160 in PD)

Quick Facts

Study Start:2025-05-12

Study Completion:2027-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07020026

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:45 Years to 85 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Ability to comply with the study procedures and attend follow-up visits. 2. Written informed consent from the participant or legal guardian. 3. 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.	1. Any other medical or psychiatric condition or lab abnormality, which in the opinion of the investigator might preclude participation. 2. For those receiving Screening DaTscan: 3. 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. 4. 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). 5. 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.

Inclusion Criteria

Exclusion Criteria

1. Ability to comply with the study procedures and attend follow-up visits.
2. Written informed consent from the participant or legal guardian.
3. 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.

1. Any other medical or psychiatric condition or lab abnormality, which in the opinion of the investigator might preclude participation.
2. For those receiving Screening DaTscan:
3. 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.
4. 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).
5. 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.

Contacts and Locations

Study Contact

Ashley Romano, RN

CONTACT

475-318-8232

info_XI001@xingimaging.com

Principal Investigator

Ken Marek, MD

STUDY_CHAIR

Institute for Neurodegenerative Disorders

Study Locations (Sites)

Institute for Neurodegenerative Disorders / XingImaging, LLC

New Haven, Connecticut, 06510

United States

Collaborators and Investigators

Sponsor: Michael J. Fox Foundation for Parkinson's Research

Ken Marek, MD, STUDY_CHAIR, Institute for Neurodegenerative Disorders

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05-12

Study Completion Date2027-06

Study Record Updates

Study Start Date2025-05-12

Study Completion Date2027-06

Terms related to this study

Additional Relevant MeSH Terms

Parkinson's Disease