Parkinson DiseasePhase 1/2NCT03675282

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

A Phase 1/2 study testing (11C)PE2I and Ioflupane in people with Parkinson Disease and REM Sleep Behavior Disorder, run by Weill Medical College of Cornell University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 20 to 100 yearsHealthy volunteers can take part
Conditions the study is for: Parkinson Disease, REM Sleep Behavior Disorder, Healthy
What is being tested?: (11C)PE2I and Ioflupane
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 82 participants
Where: 1 siteUnited States
Study dates: 14 Aug 2018to 23 Apr 2024
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 to 100 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 15Show fewer

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Hospital for Special Surgery
New York, New York, 10021

Other trials in United States

About this study

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

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.

Read the detailed description

This study will evaluate the rate of iron accumulation throughout different stages of the disease and compare it to controls Thus, the investigators will be able to see if iron starts to accumulate in those patients, way 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.

Conditions: Parkinson Disease, REM Sleep Behavior Disorder, Healthy
Being tested: (11C)PE2I, Ioflupane
Keywords: MRI, PET Scan
Medical subject headings: Parkinson Disease, REM Sleep Behavior Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

(11C)PE2IDrug
Also called PET Scan
Subjects will received (11C)PE2I PET Scans at Baseline and 24 Month Visits
IoflupaneDrug
Also called DaT scan
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

Study groups in NCT03675282
Study group	Role	What they receive
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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: Drug: (11C)PE2I; Drug: Ioflupane

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: Baseline and 24 Months

Secondary outcomes (2)

Assess Clinical Changes in Disease Arm
Assess clinical changes in disease arm, as measured by changes in unified Parkinson's disease rating scale (UPDRS) scale assessments at baseline and 24 Month visits. The UPDRS is used to follow the longitudinal course of Parkinson's disease.
The UPDRS is made up of 42 questions grouped into 4 sections:
Part I: evaluation of mentation, behavior, and mood Part II: self-evaluation of the activities of daily life (ADLs) including speech, swallowing, handwriting, dressing, hygiene, falling, salivating, turning in bed, walking, and cutting food Part III: clinician-scored monitored motor evaluation Part IV: complications of therapy
score for part I range is: 0-16 score for part II range is:0- 52 score for part III range is: 0-108 score for part IV range is: 0-23
The higher the score value, the worse symptoms are.
Measured: Baseline and 24 Months
Assess Change in PE2i PET Scan or DaT Scan
Assess changes in dopamine depletion as measured by the baseline PE2i PET scan or DaT scan compared to the 24 month PE2i PET scan or DaT scan
Measured: Baseline and 24 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Aug 201823 Apr 2024

First posted18 Sep 2018
Study start14 Aug 2018
Primary completion23 Apr 2024
Study completion23 Apr 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Other
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 82 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03675282
Sponsor's protocol ID: 1711018740
Other IDs: 1R01NS095562-01A1
Status last verified: Feb 2025
First submitted: 5 Sep 2018
Last updated: 12 Mar 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Quantitative Mapping of Substantia Nigra Iron in Parkinson's Disease and Controls
ClinicalTrials.gov ID: NCT03675282
Acronym / sponsor ID: 1711018740
Conditions: Parkinson Disease, REM Sleep Behavior Disorder, Healthy
Keywords: MRI, PET Scan
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 82 participants (actual)
Lead sponsor: Weill Medical College of Cornell UniversityUniversity, hospital or other
Collaborators: National Institute of Neurological Disorders and Stroke (NINDS)
Study start: 14 Aug 2018 (actual)
Primary completion: 23 Apr 2024 (actual)
Study completion: 23 Apr 2024 (actual)
First posted: 18 Sep 2018 (actual)
Results: Posted 12 Mar 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Other
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 6

Arm	Type	Receives
Parkinson Disease - Stage 1	Experimental	Drug: (11C)PE2I, Drug: IoflupaneMRI Brain at Baseline and 24 Months PE2i PET Scan or DaT Scan at Baseline and 24 Months Office Visit at Baseline and 24 Months
Parkinson Disease - Stage 2	Experimental	Drug: (11C)PE2I, Drug: IoflupaneMRI Brain at Baseline and 24 Months PE2i PET Scan or DaT Scan at Baseline and 24 Months Office Visit at Baseline and 24 Months
Parkinson Disease - Stage 3	Experimental	Drug: (11C)PE2I, Drug: IoflupaneMRI Brain at Baseline and 24 Months PE2i PET Scan or DaT Scan at Baseline and 24 Months Office Visit at Baseline and 24 Months
Parkinson Disease - Stage 4	Experimental	Drug: (11C)PE2I, Drug: IoflupaneMRI Brain at Baseline and 24 Months PE2i PET Scan or DaT Scan at Baseline and 24 Months Office Visit at Baseline and 24 Months
REM Sleep Behavior Disorder	Experimental	Drug: (11C)PE2I, Drug: IoflupaneMRI Brain at Baseline and 24 Months PE2i PET Scan or DaT Scan at Baseline and 24 Months Office Visit at Baseline and 24 Months
Healthy Controls	Experimental	Drug: (11C)PE2I, Drug: IoflupaneMRI Brain at Baseline and 24 Months PE2i PET Scan or DaT Scan at Baseline and 24 Months Office Visit at Baseline and 24 Months

Who may qualify

Ages: 20 to 100 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (15 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
(11C)PE2IAlso: PET ScanSubjects will received (11C)PE2I PET Scans at Baseline and 24 Month Visits	Drug	Healthy Controls, Parkinson Disease - Stage 1, Parkinson Disease - Stage 2, Parkinson Disease - Stage 3, Parkinson Disease - Stage 4, REM Sleep Behavior Disorder
IoflupaneAlso: DaT scanSubjects 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	Drug	Healthy Controls, Parkinson Disease - Stage 1, Parkinson Disease - Stage 2, Parkinson Disease - Stage 3, Parkinson Disease - Stage 4, REM Sleep Behavior Disorder

Primary outcome

Change in Sensitivity of QSM MR Imaging From Baseline MR Imaging to 24 Month MR Imaging
Time frame: Baseline and 24 Months
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

2 secondary outcomes

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

Results and safety

Results posted to the registry on 12 Mar 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Parkinson Disease - Stage 1	20	15
Parkinson Disease - Stage 2	27	17
Parkinson Disease - Stage 3	2	1
Parkinson Disease - Stage 4	0	0
REM Sleep Behavior Disorder	9	7
Healthy Controls	24	17

Primary outcome: Change in Sensitivity of QSM MR Imaging From Baseline MR Imaging to 24 Month MR Imaging

Time frame: Baseline and 24 Months. Mean (Standard Deviation). Unit: ppb

Measure	Parkinson Disease - Stage 1 n = 15	Parkinson Disease - Stage 2 n = 17	Parkinson Disease - Stage 3 n = 1	Parkinson Disease - Stage 4 n = 0	REM Sleep Behavior Disorder n = 7	Healthy Controls n = 17
Baseline	379.5896 (84.4375)	314.1832 (138.1896)	561.1894 (0)	–	288.1832 (122.8809)	261.6498 (72.7075)
24 Months	359.7905 (152.2746)	335.4785 (117.6937)	0.0 (0.0)	–	287.3132 (141.0688)	250.1543 (80.9845)

Parkinson Disease - Stage 1: Mean Difference (Final Values): 19.8, p = 0.66, paired t-test
Parkinson Disease - Stage 2: Mean Difference (Final Values): -21.3, p = 0.63, paired t-test
REM Sleep Behavior Disorder: Mean Difference (Final Values): 0.87, p = 0.99, paired t-test

Population analysed: This analysis population included Parkinson's disease patients, stages I-III, REM Sleep behavior disorder patients, and healthy controls who completed the study. One Stage III Parkinson's disease patient was excluded because their MRI protocol did not include T1, and we were therefore unable to get QSM values. 0 subjects were analyzed for the PD Stage 4 arm because no Stage 4 patients were enrolled.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data were collected over the course of the study per participant which was 2 years ± 2 months.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Parkinson's Disease Stage 1	0 of 20 (0%)	0 of 20 (0%)	0 of 20
Parkinson's Disease Stage 2	0 of 27 (0%)	0 of 27 (0%)	0 of 27
Parkinson's Disease Stage 3	0 of 2 (0%)	0 of 2 (0%)	0 of 2
Parkinson's Disease Stage 4	0 of 0	0 of 0	0
REM Sleep Behavior Disorder	0 of 9 (0%)	0 of 9 (0%)	0 of 9
Healthy Controls	0 of 24 (0%)	0 of 24 (0%)	0 of 24

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Alexander Shtilbans, MD principal investigator

Weill Medical College of Cornell University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing (11C)PE2I and Ioflupane in people with Parkinson Disease and REM Sleep Behavior Disorder, run by Weill Medical College of Cornell University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Sensitivity of QSM MR Imaging From Baseline MR Imaging to 24 Month MR Imaging (time frame: Baseline and 24 Months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03675282.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2025.