Phase 2 N=82 Other

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

Parkinson Disease · REM Sleep Behavior Disorder · Healthy

Bottom Line

View on ClinicalTrials.gov: NCT03675282 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2025

Primary outcome: Primary: Change in Sensitivity of QSM MR Imaging From Baseline MR Imaging to 24 Month MR Imaging — 379.5896; 314.1832; 561.1894; 288.1832 ppb — p=0.66

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: (11C)PE2I (Drug); Ioflupane (Drug)
Age: Adult, Older Adult · 20+ yrs
Sex: All
Sponsor: Weill Medical College of Cornell University
Primary completion: Apr 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Sensitivity of QSM MR Imaging From Baseline MR Imaging to 24 Month MR Imaging	379.5896; 314.1832; 561.1894; 288.1832; 261.6498; 359.7905	0.66
SECONDARY Assess Clinical Changes in Disease Arm	2.25; 1.88; 5; 1.67; 0.91; 6.11	0.40
SECONDARY Assess Change in PE2i PET Scan or DaT Scan	3.47; 3.10; 2.33; 3.87; 3.58; 3.07	0.30

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.

Eligibility Criteria

Inclusion Criteria

1. Idiopathic Parkinson's Disease, REM Sleep Behavior Disorder subjects without signs of Parkinsonism and normal healthy controls a. If tremor is not present, subjects must have unilateral onset and persistent asymmetry of the symptoms. b. For PD Subjects only: Age > 30 years at time of diagnosis of PD with a maximum age of 100 years old c. Hoehn & Yahr stage 15
5. History of exposure to typical or atypical neuroleptics or any dopamine blocking agent within 6 months prior to enrollment
6. Patients with psychosis/active hallucinations and memory difficulty pre-dating the onset of motor symptoms
7. History of brain surgery for PD
8. History of thyroid disease
9. History of stroke or cerebral vascular disease
10. History of drug abuse
11. History of repeated head injury or encephalitis
12. Positive dementia by DSM IV-R
13. Women of childbearing potential who are not surgically sterilized have to use a reliable measure of contraception and have a negative urine pregnancy test at the screening
14. Participation in other investigational drug trials within 30 days prior to screening
15. Contraindication for receiving MRI imaging such as presence of pacemakers, certain types of metallic implants, severe claustrophobia, history of reaction to contrast material, or renal insufficiency

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03675282). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.