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Brain Iron Mapping for Parkinson's Disease
Phase 1 & 2
Waitlist Available
Led By Alexander Shtilbans, MD
Research Sponsored by Weill Medical College of Cornell University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 24 months
Awards & highlights
Study Summary
This trial is testing whether a new method of mapping iron in the brain is more accurate than the current method, in order to eventually use the new method in clinical trials for Parkinson's Disease and REM Sleep Behavior Disorder.
Who is the study for?
This study is for people with Parkinson's Disease stages I-IV, those with REM Sleep Behavior Disorder, and healthy volunteers aged 20-100. Participants should not have anemia or other blood disorders, severe mental health issues, a history of drug abuse or certain medical conditions that could affect the trial. People with Parkinson's must be on stable medication regimens.Check my eligibility
What is being tested?
The trial is testing new brain imaging techniques to measure iron levels in a part of the brain called the substantia nigra. Researchers are comparing current R2* methods to Quantitative Susceptibility Mapping (QSM) in hopes of improving diagnosis and tracking of Parkinson's Disease.See study design
What are the potential side effects?
There may be minimal side effects from the imaging agents used ((11C)PE2I and Ioflupane), such as allergic reactions or discomfort at injection site. MRI scans are generally safe but can cause discomfort for those with claustrophobia or specific implants.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Sensitivity of QSM MR imaging from baseline MR imaging to 24 month MR imaging
Secondary outcome measures
Assess change in PE2i PET scan or DaT scan
Assess clinical changes in disease arm
Trial Design
6Treatment groups
Experimental Treatment
Group I: REM Sleep Behavior DisorderExperimental Treatment2 Interventions
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
Group II: Parkinson Disease - Stage 4Experimental Treatment2 Interventions
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
Group III: Parkinson Disease - Stage 3Experimental Treatment2 Interventions
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
Group IV: Parkinson Disease - Stage 2Experimental Treatment2 Interventions
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
Group V: Parkinson Disease - Stage 1Experimental Treatment2 Interventions
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
Group VI: Healthy ControlsExperimental Treatment2 Interventions
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
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,339 Previous Clinical Trials
649,308 Total Patients Enrolled
Weill Medical College of Cornell UniversityLead Sponsor
1,054 Previous Clinical Trials
1,316,446 Total Patients Enrolled
Alexander Shtilbans, MDPrincipal InvestigatorWeill Medical College of Cornell University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had thyroid problems in the past.You have a history of using drugs in a way that is not prescribed by a doctor.People with Parkinson's disease or REM sleep behavior disorder without signs of Parkinson's disease, and normal healthy individuals.People diagnosed with Parkinson's disease must be between 30 and 100 years old.You have severe depression based on a specific score.You do not have severe anemia, low iron levels, or other blood-related problems.You have had multiple head injuries or encephalitis in the past.You have atypical or secondary forms of Parkinson's disease.You are not sure if you have Parkinson's disease, and your scans do not show certain brain changes related to the condition.- You have Parkinson's Disease with specific symptoms and age criteria.
- You have REM Sleep Behavior Disorder without signs of Parkinson's Disease.
- You are a healthy control without any symptoms.You don't have severe anemia, low iron levels, or other blood problems.You have Parkinson's disease that is less severe than stage 5 according to the Hoehn & Yahr scale.You are currently taking specific medications for Parkinson's disease, or you have never taken any Parkinson's medications before.You cannot have an MRI because you have a pacemaker, certain metal implants, severe fear of small spaces, history of bad reaction to contrast dye, or kidney problems.If you don't have tremors, your symptoms should start on one side of your body and stay uneven.You have been diagnosed with dementia according to DSM IV-R.You have had surgery on your brain for Parkinson's disease.You have taken certain types of medications that affect dopamine within the past 6 months.You have a history of experiencing hallucinations and memory problems before having motor symptoms.You have had a stroke or other brain blood vessel disease in the past.If you have Parkinson's disease, you are currently taking certain medications for it, or you have never taken any medication for it.1. You have Parkinson's disease or REM sleep behavior disorder without signs of Parkinsonism, or you are a healthy individual without any symptoms of these conditions.
2. If you have Parkinson's disease, you were diagnosed after the age of 30 and are no older than 100, and your symptoms are not too severe.
Research Study Groups:
This trial has the following groups:- Group 1: Parkinson Disease - Stage 2
- Group 2: REM Sleep Behavior Disorder
- Group 3: Parkinson Disease - Stage 1
- Group 4: Healthy Controls
- Group 5: Parkinson Disease - Stage 4
- Group 6: Parkinson Disease - Stage 3
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this investigation extend to participants aged sixty or over?
"Per the requirements for enrollment, potential participants should be between 20 and 100 years old."
Answered by AI
Is there currently an opportunity for individuals to join this investigation?
"At the moment, clinicaltrials.gov lists this medical trial as inactive. The study was initially posted on August 14th 2018 and most recently modified on January 26th 2022; however, other trials are still recruiting participants - amounting to 1671 in total."
Answered by AI
Is there any eligibility criteria for joining this clinical trial?
"At present, this clinical trial is enlisting 82 individuals with REM Sleep Behaviour Disorder between the ages of 20 and 100. Notably, those participating must meet a range of criteria: 1) diagnosis of idiopathic Parkinson's disease or lack thereof; 2) optimised dopaminergic drug regimen if applicable; 3) no overt anemia/iron deficiency etc.; 4) deemed healthy to undergo MRI and PET imaging assessments; 5) age ranging from 20-80 for control subjects & RBD patients only; 6) signed consent form."
Answered by AI
Who else is applying?
What state do they live in?
New York
New Jersey
How old are they?
18 - 65
What site did they apply to?
Hospital for Special Surgery
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
I like help 👌.
PatientReceived 1 prior treatment
How responsive is this trial?
Most responsive sites:
- Hospital for Special Surgery: < 24 hours
Typically responds via
Email
Average response time
- < 1 Day
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