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

• Register: ClinicalTrials.gov
• Last refreshed on: 1 April 2024
• Main ID: NCT03675282
• Date of registration: 05/09/2018
• Prospective Registration: No
• Primary sponsor: Weill Medical College of Cornell University
• Public title: Quantitative Mapping of Substantia Nigra Iron in Parkinson's Disease (Stages I-IV, REM Sleep Behavior Disorder) and Controls
• Scientific title: Quantitative Mapping of Substantia Nigra Iron in Parkinson's Disease and Controls
• Date of first enrolment: August 14, 2018
• Target sample size: 82
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT03675282
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Other. Masking: None (Open Label).
• Phase: Phase 1/Phase 2

Countries of recruitment

United States

Contacts

• Name: Alexander Shtilbans, MD
• Affiliation: Weill Medical College of Cornell University

Key inclusion & exclusion 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 < V (if PD)

- 2. 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

- 3. No overt anemia, iron deficiency, or other hematological disorders

- 4. 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

Exclusion Criteria:

- 1. 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)

- 2. Patients with uncertainty as to having classical Parkinson's disease, such as those
who might have scans without evidence of dopaminergic deficits (SWEDDs)

- 3. Presence of a medical or psychiatric comorbidity that can compromise participation
in the study

- 4. Patients with clinically significant depression as determined by the Beck
depression score > 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



Age minimum: 20 Years
Age maximum: 100 Years
Gender: All

Health Condition(s) or Problem(s) studied

Healthy

REM Sleep Behavior Disorder

Parkinson Disease

Intervention(s)

Drug: (11C)PE2I

Drug: Ioflupane

Primary Outcome(s)

Change in Sensitivity of QSM MR imaging from baseline MR imaging to 24 month MR imaging [Time Frame: Baseline and 24 Months]

Secondary Outcome(s)

Assess clinical changes in disease arm [Time Frame: Baseline and 24 Months]

Assess change in PE2i PET scan or DaT scan [Time Frame: Baseline and 24 Months]

Secondary ID(s)

1711018740

1R01NS095562-01A1

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Institute of Neurological Disorders and Stroke (NINDS)