CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 82 enrolled
Drug / intervention
(11C)PE2I +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03675282
NCT03675282Phase 2Completed

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

Weill Medical College of Cornell University·interventional·Posted Sep 18, 2018·Updated Mar 12, 2025

In Brief

A Phase 2 clinical trial evaluating (11C)PE2I and Ioflupane for Parkinson Disease and 2 related conditions. Completed, enrolled 82 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedSep 18, 2018
Enrollment StartAug 14, 2018
Primary CompletionApr 23, 2024
TodayJul 2, 2026
Enrollment to primary: 5.7 yearsPosted 7.8 years ago

Interventions

(11C)PE2Idrug

Subjects will received (11C)PE2I PET Scans at Baseline and 24 Month Visits

Ioflupanedrug

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