NCT03675282

Quantitative Mapping of Substantia Nigra Iron in Parkinson's Disease (Stages I-IV, REM Sleep Behavior Disorder) and Controls

Quantitative Mapping of Substantia Nigra Iron in Parkinson's Disease and Controls

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 82 (actual)
• Sponsor: Weill Medical College of Cornell University · Academic / Other
• Sex: All
• Age: 20 Years – 100 Years
• Healthy volunteers: Accepted

Summary

Prospective, single center study to determine whether the current R2\* iron mapping method for measuring nigral iron changes in the brain can be significantly improved by using the Quantitative Susceptibility Mapping (QSM) based iron mapping techniques with the goal of validating QSM for potential use in later clinical trials. Subjects with a diagnosis of Parkinson's Disease, Rapid Eye Movement (REM) Sleep Behavior Disorder, and Normal Volunteers who meet the inclusion and exclusion criteria will be eligible for participation in this study.

Detailed description

This study will evaluate the rate of iron accumulation throughout different stages of the disease and compare it to controls Thus, the investigators will be able to see if iron starts to accumulate in those patients, way before motor symptoms of Parkinson disease develop. Hypothetically, an iron chelator drug could remove excessive iron from the brain and slow down process of neurodegeneration. A precise technique to measure iron in the brain and to detect small changes therefore is needed as a radiological marker of disease progression and/or therapeutic effect in clinical trials.

Conditions

• Parkinson Disease
• REM Sleep Behavior Disorder
• Healthy

Interventions

Type	Name	Description
DRUG	(11C)PE2I	Subjects will received (11C)PE2I PET Scans at Baseline and 24 Month Visits
DRUG	Ioflupane	Subjects will receive a DaT scan at baseline and 24 month visits if they don't receive a PE2I PET scan at baseline and 24 month visits

Timeline

• Start date: 2018-08-14
• Primary completion: 2024-04-23
• Completion: 2024-04-23
• First posted: 2018-09-18
• Last updated: 2025-03-12
• Results posted: 2025-03-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study