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

NCT03675282 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: 17110187401R01NS095562-01A1
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Parkinson Disease; REM Sleep Behavior Disorder; Healthy

Keywords

MRI; PET Scan

Outcome Measures

Primary Outcomes (1)

• Change in Sensitivity of QSM MR Imaging From Baseline MR Imaging to 24 Month MR Imaging

  Change in Sensitivity of QSM MR imaging as compared to R2\* from baseline MR imaging to 24 month MR imaging, as measured by Radiology reader agreements

  Baseline and 24 Months

Secondary Outcomes (2)

• Assess Clinical Changes in Disease Arm

  Baseline and 24 Months

• Assess Change in PE2i PET Scan or DaT Scan

  Baseline and 24 Months

Study Arms (6)

Parkinson Disease - Stage 1

EXPERIMENTAL

MRI Brain at Baseline and 24 Months PE2i PET Scan or DaT Scan at Baseline and 24 Months Office Visit at Baseline and 24 Months

Drug: (11C)PE2I; Drug: Ioflupane

Parkinson Disease - Stage 2

EXPERIMENTAL

MRI Brain at Baseline and 24 Months PE2i PET Scan or DaT Scan at Baseline and 24 Months Office Visit at Baseline and 24 Months

Drug: (11C)PE2I; Drug: Ioflupane

Parkinson Disease - Stage 3

EXPERIMENTAL

MRI Brain at Baseline and 24 Months PE2i PET Scan or DaT Scan at Baseline and 24 Months Office Visit at Baseline and 24 Months

Drug: (11C)PE2I; Drug: Ioflupane

Parkinson Disease - Stage 4

EXPERIMENTAL

MRI Brain at Baseline and 24 Months PE2i PET Scan or DaT Scan at Baseline and 24 Months Office Visit at Baseline and 24 Months

Drug: (11C)PE2I; Drug: Ioflupane

REM Sleep Behavior Disorder

EXPERIMENTAL

MRI Brain at Baseline and 24 Months PE2i PET Scan or DaT Scan at Baseline and 24 Months Office Visit at Baseline and 24 Months

Drug: (11C)PE2I; Drug: Ioflupane

Healthy Controls

EXPERIMENTAL

MRI Brain at Baseline and 24 Months PE2i PET Scan or DaT Scan at Baseline and 24 Months Office Visit at Baseline and 24 Months

Drug: (11C)PE2I; Drug: Ioflupane

Interventions

(11C)PE2I DRUG

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

Also known as: PET Scan

Healthy Controls; Parkinson Disease - Stage 1; Parkinson Disease - Stage 2; Parkinson Disease - Stage 3; Parkinson Disease - Stage 4; REM Sleep Behavior Disorder

Ioflupane DRUG

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

Also known as: DaT scan

Healthy Controls; Parkinson Disease - Stage 1; Parkinson Disease - Stage 2; Parkinson Disease - Stage 3; Parkinson Disease - Stage 4; REM Sleep Behavior Disorder

Eligibility Criteria

• Age: 20 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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 \< V (if PD)
• \. For PD subjects only: Receiving an optimized dopaminergic regimen (i.e., either MAO-B inhibitor, a dopamine agonist and/or low doses of L-dopa, with dose change no more frequent than every 6-month in the course of the study); or medications naive
• \. No overt anemia, iron deficiency, or other hematological disorders
• \. Deemed healthy and able to undergo MRI and PE2i PET imaging by the Site Investigator, based on screening assessments-- medical history, physical examination 5. For Controls \& REM Sleep Behavior Disorder Subjects Only: Age 20-80; willing to undergo multiple imaging sessions 6. Signed informed consent form

You may not qualify if:

• \. Patient with atypical parkinsonism (such as suspected Progressive Supranuclear Palsy, Multiple System Atrophy) and secondary parkinsonism (such as normal pressure hydrocephalus, drug-induced, or vascular parkinsonism)
• \. Patients with uncertainty as to having classical Parkinson's disease, such as those who might have scans without evidence of dopaminergic deficits (SWEDDs)
• \. Presence of a medical or psychiatric comorbidity that can compromise participation in the study
• \. Patients with clinically significant depression as determined by the Beck depression score \> 15
• \. History of exposure to typical or atypical neuroleptics or any dopamine blocking agent within 6 months prior to enrollment
• \. Patients with psychosis/active hallucinations and memory difficulty pre-dating the onset of motor symptoms
• \. History of brain surgery for PD
• \. History of thyroid disease
• \. History of stroke or cerebral vascular disease
• \. History of drug abuse
• \. History of repeated head injury or encephalitis
• \. Positive dementia by DSM IV-R
• \. 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
• \. Participation in other investigational drug trials within 30 days prior to screening
• \. 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

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (1)

Hospital for Special Surgery

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Parkinson Disease; REM Sleep Behavior Disorder

Interventions

N-(3-iodoprop-2-enyl)-2-beta-carbomethoxy-3-(4-methylphenyl)nortropane; Magnetic Resonance Spectroscopy; ioflupane

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; REM Sleep Parasomnias; Parasomnias; Sleep Wake Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Results Point of Contact

• Title: Carly Skudin; Research Program Manager
• Organization: Weill Cornell Medicine

cas4010@med.cornell.edu

212-746-2003

Study Officials

• Alexander Shtilbans, MD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2018
• First Posted: September 18, 2018
• Study Start: August 14, 2018
• Primary Completion: April 23, 2024
• Study Completion: April 23, 2024
• Last Updated: March 12, 2025
• Results First Posted: March 12, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)