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

Clinical Trial Details

The purpose of the IRONMAN study is to establish a noninvasive accurate imaging method for measuring and quantifying iron changes in the brain of subjects with Parkinson’s disease or REM Sleep Behavior Disorder. We will evaluate the rate of iron accumulation throughout different stages of Parkinson’s Disease and compare it to REM Sleep Behavior Disorder patients and healthy volunteers, over a period of 24 months. Thus, we will be able to see if iron starts to accumulate in those patients, long 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.

Subjects will receive $100 for the first PET scan, $100 for the second PET scan, and $25 for the second MRI. Subjects who are eligible and complete all research visits will receive a total of $225 over the course of the two years of enrollment. We also can reimburse for travel expenses to the study site.

Key Eligibility: 
    • Men and women ages ~45 to 80
    • People with Parkinson’s Disease, REM Sleep Behavior Disorder, and Healthy Volunteers
    • Able and willing to undergo MRI and PET imaging

Detailed eligibility criteria will be reviewed upon contacting the study team.

Study contact by location

Upper East Side - Manhattan

Contact(s)

Carly Skudin
(212) 746-2003
cas4010@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

1711018740

ClinicalTrials.gov:

NCT03675282

Status

Open to Enrollment

Age Group

Adult

Sponsor