Clinical trial NCT03675282
Conditions: Parkinson Disease REM Sleep Behavior Disorder Healthy
Keywords: MRI PET Scan
Sponsor: Weill Medical College of Cornell University
Start date: 2018-08-14; Completion date: 2024-04-23
Enrollment: 82 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

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.

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.

Arms: arm 1: 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 arm 2: 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 arm 3: 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 arm 4: 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 arm 5: 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 arm 6: 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
Interventions: intervention 1: (11C)PE2I intervention 2: Ioflupane
Intervention descriptions: intervention 1: Subjects will received (11C)PE2I PET Scans at Baseline and 24 Month Visits intervention 2: 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

Protocol documents:
Prot_SAP_001.pdf: 
1 
 
PROTOCOL TITLE: Quantitative Mapping of Substantia Nigra Iron in Parkinson’s Disease (Stages I-IV, REM 
sleep behavior disorder) and Controls 
 
PRINCIPAL INVESTIGATOR: Dr. Alexander Shtilbans, MD, PhD, Weill Cornell Medicine 
IRB Protocol #: 1711018740 
ClinicalTrials.gov Identifier: NCT03675282 
 
Current Version: September 10, 2021 
 
Prior Version Dates: 
Version September 10, 2021 
Version August 4, 2021 
Version May 11, 2021 
Version September 9, 2019 
Version February 2, 2019 
Version November 28, 2018 
Version October 25, 2018 
Version September 26, 2018 
Version June 29, 2018 
Version November 9, 2017 
 
 
 
 
 
 
 
 
 
 
 
 
 


2 
 
 
 
 
 
BACKGROUND 
To help the development of  iron chelation as a potential therapy for Parkinson's  Disease  (PD),   
this   study is  designed  to  establish  an  accurate and sensitive Quantitative Susceptibility Mapping 
(QSM)-based Substantia Nigra (SN) iron mapping method. Furthermore, should  trials  of   iron   
chelation   therapy in PD prove that this intervention has clinical effectiveness, an improved 
method to measure SN iron concentration (such as QSM as proposed  herein)  could  become a 
companion Radiological Biomarker for triage and response assessment; and potentially for dose 
modulation to prevent potential over-treatment. We propose a study to assess SN iron changes 
to test the hypothesis that the QSM based iron mapping technique is more sensitive than the 
current R2* method for monitoring nigral iron change in PD patients. Prooxidant iron accumulation 
in the substantia nigra pars compacta  (SNc)  in  the  midbrain  is  one possible reason for SNc 
vulnerable to neurodegeneration. Increased iron in SN of PD patients have been evaluated by 
various MRI methods to be correlated with disease severity, duration, and other patient 
assessments. Longitudinal studies show that iron estimated by MRI progressively increase in PD 
subjects but not in controls. Iron elevation can  cause cell death mediated by oxidative stress. The 
increased iron is located within individual dopaminergic neurons in the PD SNc, which leads to 
the following consequences: 1) The interaction of ferrous iron (Fe(II)) with oxygen (hydrogen 
peroxide) readily generates highly toxic hydroxyl radicals (HO¿) via Fenton chemistry. Post 
mortem PD-affected brains display increased lipid peroxidation, oxidative damage to DNA, and 
lowered levels  of  the  reduced  form of glutathione, which all reflect oxidative stress. 2) Iron can 
impact the aggregation of alfa-synuclein, the major component of Lewy bodies in PD. Alfa-synuclein 
binds to iron, which accelerates its aggregation into fibrils and is consistent with pathological finding 
of enriched iron in Lewy bodies. Alfa-synuclein has also been shown to directly generate hydrogen 
peroxide when  it  aggregates and, in the presence of iron, produces toxic hydroxyl radicals. 3) 
The aggregation of alfa-synuclein in PD can proliferate microglia, and iron can polarize microglia 
to the  pro-inflammatory  M1  phenotype that produces cytotoxic  cytokines,  which is observed in 
the advanced dopaminergic degeneration in symptomatic PD. While noninvasive MRI is sensitive to 
the presence of iron  that  is  paramagnetic,  current MRI methods to quantify iron are highly 
problematic. A commonly used method is the signal decay rate R2*, to be precise, the decay rate 
of the magnitude signal along the data sampling echo time TE in the commonly used gradient 
echo sequence. We have found that R2* suffers from various problems including 1) dependences 
on imaging parameters including voxel size and field strength, 2) blooming artifacts, which are 
particularly  strong at  SNc  that is near the nasal cavity air-tissue interface of strong magnetic 
susceptibility difference, and 3) interfering effects from cellular contents such as membranes, 
proteins (neuromelanin, alpha-synuclein, etc). Our investigations have lead to the physics insight 
to model MRI  signal  dependence on paramagnetic iron, which is the so called forward problem 
from iron to MRI signal phase or field. Accordingly, we have innovated the inverse solution from 
field to iron source, which is termed as quantitative susceptibility mapping (QSM). We are 
performing ex vivo studies to demonstrate that QSM is much more accurate that R2* for measuring 


3 
 
iron by comparing with elemental analysis, the gold standard. This in vivo patient project is designed 
to demonstrate that QSM will provide much better image quality and higher sensitivity than R2* 
quantitatively mapping iron in SNc. 
 
STUDY DESIGN 
Prospective, single center trial to determine whether the current R2* iron mapping method for 
measuring nigral iron changes in Parkinson's Disease (PD) 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. This study will include six cohorts - 
Parkinson's Disease (PD) Stage I (20 subjects), PD Stage II (20 subjects), PD Stage III (20 subjects), 
PD Stage IV (20 subjects), REM Sleep Behavior Disorder (RBD) (10 subjects), and healthy controls (10 
subjects). Subjects who meet the inclusion and exclusion criteria and whom sign an informed 
consent form will be eligible for participation in this  study and will undergo the following 
assessments regardless of cohort stratification. Screening and Baseline: Subjects will be  seen  in the 
Movement Disorder Clinic within the Department of Neurology at Weill Cornell Medicine, or at 
HSS, or at Cornell Ithaca (other recruiting sites) for an in-office visit which will include review of 
medical history, concomitant medication review, physical exam, urine pregnancy test (females of 
childbearing potential age) and completion of clinical surveys. This visit may be a standard  of  care,  
office  visit, or may be an office visit performed for research purposes. If standard of care, in-office 
neurological assessments have already been performed within three months of study imaging, this 
may be used to satisfy the study baseline/screening and 24 month in office assessments. All subjects, 
whether recruited at WCM or HSS, will receive either a PE2i Positron Emission Tomography (PET) scan 
or DaT single photon emission computed tomogrpahy (SPECT) scan, and Magnetic Resonance Imaging 
(MRI) scan of the brain at WCM. If the subject received a standard of care MRI scan of the brain within 
1 month of  screening, this exam will be utilized to satisfy the baseline requirement for an MRI of 
the brain. However, if a standard of care MRI of the brain was performed either at an outside 
facility or at New York Presbyterian-Weill Cornell Medicine outside the required 1 month window 
to enrollment, the  MRI  of the brain will be repeated at Baseline as performed for research 
purposes. Month 24 (+/- 2 Months): Subjects will  be  seen  in the Movement Disorder Clinic within 
the Department of Neurology at Weill Cornell Medicine, or at HSS for an in-office visit (either 
as a standard of care office visit, or may be an office visit for research purposes) which will include 
review of medical history, review concomitant medications, physical exam,  urine  pregnancy   test   
(females of childbearing potential age), complete surveys; and subjects will receive a repeat PE2i 
PET scan or DaT scan and MRI of the brain at WCM. The following  outlines which procedures are 
considered performed for research purposes vs. performed for standard of care purposes for PD and 
RBD Cohorts: Performed for Research Purposes: PE2i PET Scan or DaT scan performed at Baseline 
and Month 24 visit; MRI of the brain performed at Baseline (only if repeated for research purposes 
as outlined above) and Month 24 visit; Urine pregnancy test for female subjects of child-bearing 
potential age  performed  at  baseline  and  Month 24 visit. Performed for  Standard of Care 
Purposes: Office visit performed at Baseline and Month 24 visit (unless subjects are asked to return 
for an office visit performed for research purposes with the Neurology team at WCM or HSS); 
MRI of the brain performed at Baseline visit; Completion of clinical neurological surveys (e.g. 
UPDRS). Subjects recruited at Cornell Ithaca will have the MRI at the Cornell MRI Facility and may or 
may not have a PE2i PET scan or DaT scan at WCM. Subjects who receive the DaT scan will have to 
take Lugol’s solution before scanning to protect their thyroid. 


4 
 
Our primary objective is to establish that Quantitative Susceptibility Mapping (QSM) is more sensitive 
than R2* for nigral iron mapping in monitoring PD iron overload.  
 
Our secondary objective is to evaluate rate of iron accumulation throughout different disease stages. 
1. Unified Parkinson’s Disease Rating Scale (UPDRS) scores to monitor for clinical changes. 2. 
Quantitative PE2i PET scan estimations to monitor for dopaminergic degeneration. 
 
INCLUSION AND 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-months in the course of the study); or medications naïve 
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 and 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  


5 
 
7.  History of brain surgery for PD  
8.  Untreated 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. 
 
 
DATA AND SAFETY MONITORING PLAN 
To assess both safety and efficacy of PE2i study procedures, intra-imaging monitoring will be performed 
to assess subject safety. In addition, subjects will return for in-office physician visits at designated time 
points (baseline and 24 months) where physical exam, vital check, and adverse events will be assessed 
and tabulated. 
There are no defined stopping rules however,  in  the  event  that  the  FDA, IRB, or other regulatory 
agencies request stoppage, all study activities would be immediately halted. The goal of the study 
is to to establish an accurate and sensitive QSM-based SNc iron mapping method through 
observation only so there is no therapeutic intent and, thus no defined stopping rules. 
Circumstances for subject termination/dropout due to study-related adverse events are highlighted 
in the adverse events-related termination section listed below. 
Adverse events that may cause termination/dropout of a subject: generally, inability to tolerate the 
study procedures, imaging: claustrophobia during imaging studies or inability to obtain venous access. 
Anticipated adverse events and risks of study interventions: 
1. Pe2i scans. Subjects may experience discomfort from lying still on their back for each scan; 
Some people feel claustrophobic in  the  PET  scanner.  If   this   happens the scan will stop 
immediately. PE2i-PET scans are experimental studies  that  may be conducted only for 
medical research purposes. PE2i-PET involves exposure to radiation, and that exposure 
is increased the more often such tests are done. Radiation exposure at certain doses can 
potentially cause cancer. The PE2i tracers are radioactive because one of the atoms 
(Carbon-11) that make up the drug has been man-made in such a way that it will 
spontaneously decompose. When it does, it will give off a type of  radiation  in  the form 
of rays. These special type of rays are a form of radiation that cannot be seen with the 
human eye, but the PET camera has sensors that can detect where it is coming from inside 
your body. These rays will be used to make pictures of the subject's brain. The total amount 


6 
 
of radiation that subjects will be exposed to from the PET scans in this study is  a  little  
less  than the amount of radiation exposure allowed for occupational workers over a 
period of one year. There are always theoretical risks associated with exposure to radiation 
of any kind, including the risks of developing cancer and hardening of the arteries. These 
risks are considered within acceptable limits for human subjects who will not personally 
benefit from their participation in the research study.  
2. Allergic reactions. With any drug (radioactive chemical substance used in PE2i PET 
scans), there is a possibility of an allergic reaction. Allergic reactions  most  commonly  
are  mild  such as a rash, cough, dizziness, or fainting, hives, itching, chest tightness, 
shortness of breath or wheezing. Rarely, a more severe and possibly even life-threatening 
reaction can occur, such  as  anaphylaxis (a reaction which may involve shortness of 
breath, swelling or closing of the airway and/or drop in blood pressure). In the event of 
an allergic reaction, medical treatment will be immediately available from the study 
staff. The risks of an allergic reaction from imaging exams in this study are very low. 
3. IV catheter. Before each PE2i PET scan study begins, a catheter will be placed in the 
subject's forearm. Catheter placement may cause bleeding, bruising, redness, swelling 
discomfort, and/or pain at the needle site or dizziness and fainting. The bruising and 
discoloration at the areas where the venous catheters are inserted may last for several 
days after the study. On rare occasions, they may cause clot formation and infection. The 
subject will be instructed to notify the study physician right away if symptoms are 
caused from the IV catheter.  
4. MRI scans. There are no known risks or adverse effects resulting directly from 
exposure to magnetic fields and radiofrequency signals used  in  the  MRI  imaging   other   
than the potential risks  associated with the scanning procedure summarized below: A. 
Claustrophobia. Some subjects may feel claustrophobic in the MR scanner. If this 
happens the study team will stop the scan immediately. B. Metallic Foreign Body Risks. 
Subjects may not be able to undergo MRI scanning if they have pacemaker, or certain 
other implanted electronic or metallic devices. Subjects will be screened for MRI 
contraindications during the screening visit.  
5. DaT scans. The most common side effects of DaT imaging are headache, increased appetite, 
and dizziness. However, it is important for you to know that the injection of DaTscan may 
include risks that cannot be predicted, although for the purposes of this study, it is being used 
in accordance with its FDA approved usage. The insertion of the IV may feel uncomfortable and 
may leave a bruise. You will need to lie very still under the camera for up to 1 hour, which may 
be uncomfortable. The DaT scan included in this study is employed routinely in the care of 
patients with medical conditions. It involves exposure to radiation and that exposure is 
increased the more often such tests are done. Radiation exposure at certain doses can 
potentially cause cancer. Any possible increase in cancer risk associated with participation in 
this study is within acceptable limits for human research subjects. 
 
In order to immediately recognize the adverse events that do occur, appropriate screening will be 
performed, including -physical exam, vitals signs, urine pregnancy test to verify eligibility before 
initiating any study related procedures. On the day of PE2i PET or DaT scan imaging, subject's vital 
signs will be taken and injection-site tolerance will be assessed after the injection of radioactive 
material. Any assessment of adverse events will be documented and reported as necessary. 


7 
 
To minimize any negative impact on subjects resulting from study closure or a subject being 
terminated from the study: in the event of premature discontinuation, subjects will receive adequate 
clinical follow-up from their treating physicians in accordance with standard of care follow up 
guidelines. 
 
Appropriate screening will be performed, including physical exam, vital signs, urine pregnancy test to 
verify eligibility before initiating any study related procedures. On the day of PE2i PET or DaT scan 
imaging, subject’s vital signs will be taken and injection-site tolerance will be assessed after the 
injection of radioactive material. Any assessment of adverse events will be documented and reported 
as necessary. 
 
In the event of premature discontinuation, subjects will receive adequate clinical follow-up from their 
treating physicians in accordance with standard of card follow up guidelines.  
Adverse events will be graded on severity, attribution, and expectedness. All AEs whether related 
or not, anticipated or not, will be reported to the IRB. Severity defined as: Mild: the subjects is 
aware of the sign or symptom, but it does not interfere with his/her usual daily activities and/or  
it  is of no clinical consequence. Moderate: the AE interferes with the usual daily activities of the 
subject of it is of some clinical consequence. Severe: the subject is unable to work normally or to carry 
out his/her usual daily activities, and/or AE is of definite clinical consequence. AE's will be reported 
to the WCMC IRB as they occur. According to local requirements, the study team will communicate 
relevant safety information to the appropriate agency(ies), IRB, and/or all active investigators as it 
becomes available. 
 
We will be using a medical monitor. The monitor will be affiliated with WCMC-NYP and is a part of the 
research study. 
 
STATISTICAL ANALYSIS PLAN 
Clinical outcome assessments: The six subject cohorts will be compared to assess differences in 
their clinical evaluations and MRI iron measurements obtained in this study. MRI iron measurements 
will be correlated with clinical evaluations to estimate iron overload effects at baseline visit and 
month 24 visit after enrollment. Also, these MRI iron measurements will be correlated with rate of 
dopaminergic loss if detected by PE2i PET or DaT scan imaging. Statistical analyses: All analyses will 
be performed using a statistical software (SPSS, Chicago, IL). The kappa test will be used to assess 
reader agreements, and covariance analysis (adjusted for baseline differences) to estimate clinical 
outcomes as measured by UPDRS at baseline and 24 Months, and PE2i PET or DaT scans at baseline 
and 24 Months. For non-normally distributed data, the robustness will be checked after log 
transformation. The analysis of variance assumption will be validated by residual analysis, and the 
size   effect will be adjusted for baseline differences. Correlation and logistic regression will be 
performed among various MRI and PE2i PET or DaT scan measurements and other clinical data. The 
longitudinal data will be modeled using the generalized estimating equation (GEE) to assess 
significant change. Paired t-test and ROC curve comparison will be performed to assess differences 
between QSM and R2*. 
 


8 
 
 

ICF_000.pdf: 
WCM IRB #1711018740 
NCT03675282 
Quantitative Mapping of Substantia Nigra Iron in Parkinson’s Disease (Stages I-IV, REM Sleep Behavior 
Disorder) and Controls 
PI: Alexander Shtilbans, MD, PhD 
Approved for use: 12/06/2021 – 12/05/2022 


1 
WEILL CORNELL MEDICAL COLLEGE 
 
 
IRB Protocol # 
1711018740 
Consent version date:  
11/30/2021 
 
Rev 10-2014 
WEILL CORNELL MEDICAL COLLEGE 
 
Informed Consent and HIPAA Authorization for Clinical Investigation 
 
 
Project Title: Quantitative Mapping of Substantia Nigra Iron in Parkinson's Disease (Stages I-
IV, REM sleep behavior disorder) and Controls_______________________________________ 
Project #:   1711018740 
 
 
 
 
 
 
 
Principal Investigator: Alexander Shtilbans, MD___ 
 
 
 
 
______ 
Subject Name/Number: _________________________________________________________ 
MRN: ________________________________________________________________________ 
 
INSTITUTION: Weill Cornell Medical College 
                             Hospital for Special Surgery 
    
INTRODUCTION 
 
You are invited to consider participating in a research study. You were selected as a possible 
participant in this study because you have either Parkinson’s disease (Stages 1 through 4) or REM 
Sleep Behavior Disorder (RBD).  
 
Please take your time to make your decision.  It is important that you read and understand several 
general principles that apply to all who take part in our studies: 
 
(a) Taking part in the study is entirely voluntary.    
(b) Personal benefit to you may or may not result from taking part in the study, but knowledge 
gained from your participation may benefit others.  
(c) You may decide not to participate in the study or you may decide to stop participating in the 
study at any time without loss of any benefits to which you are entitled.   
The purpose and nature of the study, possible benefits, risks, and discomforts, other options, your 
rights as a participant, and other information about the study are discussed below. Any new 
information discovered which might affect your decision to participate or remain in the study will be 
provided to you while you are a participant in this study.  You are urged to ask any questions you have 
about this study with members of the research team. You should take whatever time you need to 
discuss the study with your physician and family.  The decision to participate or not to participate is 
yours.  If you decide to participate, please sign and date where indicated at the end of this form.   
06-Dec-2021 -
05-Dec-2022


2 
WEILL CORNELL MEDICAL COLLEGE 
 
 
IRB Protocol # 
1711018740 
Consent version date:  
11/30/2021 
 
Rev 10-2014 
 
The research study is being funded by the National Institute of Neurological Disorders and 
Stroke. 
 
Alexander Shtilbans, MD is the principal investigator from Department of Neurology and primary 
contact for your participation and progress while on study. 
 
The study baseline/screening visit will take place at the Weill Cornell Parkinson’s Disease & 
Movement Disorder Institute, 428 East 72nd Street, Suite 400, New York NY 10021, or at 
Hospital for Special Surgery. 
 
Some portions of this study may take place at:   
Weill Cornell Citigroup Biomedical Imaging Center, 516 E72nd Street, New York NY 10021 
Weill Cornell Imaging at NewYork-Presbyterian 
Nuclear Medicine, New York Presbyterian Hospital, 525 East 68th Street, STARR 2, New York 
NY 10065 
Cornell University - Ithaca Magnetic Resonance Imaging Facility (CMRIF), Martha Van 
Rensselaer Hall, 116 Reservoir Ave, Ithaca, NY 14853 
 
 
WHY IS THE STUDY BEING DONE? 
 
The purpose of this study is to establish a noninvasive accurate imaging method for measuring 
and quantifying iron changes in the brain of subjects with Parkinson’s disease or REM Sleep 
Behavior Disorder (a condition which could start many years prior to the onset of the motor 
symptoms in Parkinson’s Disease). This study will evaluate the rate of iron accumulation 
throughout different stages of the disease and compare it to controls (group of individuals who 
do not have Parkinson’s Disease or REM Sleep Behavior Disorder who are participating in this 
study). Thus, we will be able to see if iron starts to accumulate in patients with Parkinson’s 
Disease or REM Sleep Behavior Disorder, potentially before motor symptoms develop. 
 
In this study we hope to monitor you over a period of 24 months to observe any long-term 
changes in your imaging (MRI) test results and clinical symptoms. Subjects who are enrolled 
with either Parkinson’s Disease or REM Sleep Behavior Disorder will undergo the same clinical 
and imaging assessments. For a detailed description of the different assessments please refer to 
the schedule of activities in the “What’s Involved in the Study?” section. 
 
HOW MANY PEOPLE WILL TAKE PART IN THE STUDY? 
Participants in the study are referred to as subjects. 
About 100 subjects will take part in this study.  There will be six groups of participants based on 
diagnosis, these groups include:   
Parkinson’s Disease Stage 1 (20 subjects) 
Parkinson’s Disease Stage 2 (20 subjects) 


3 
WEILL CORNELL MEDICAL COLLEGE 
 
 
IRB Protocol # 
1711018740 
Consent version date:  
11/30/2021 
 
Rev 10-2014 
Parkinson’s Disease Stage 3 (20 subjects) 
Parkinson’s Disease Stage 4 (20 subjects) 
REM Sleep Behavior Disorder (10 subjects) 
Healthy Controls (10 subjects)  
 
All of the subjects will be recruited here at Weill Cornell Medicine or Hospital for Special Surgery. 
 
 
 
 
WHAT IS INVOLVED IN THE STUDY? 
 
If you decide to participate in this study, you will be asked to sign this consent form and you will 
undergo a Screening/Baseline visit to make sure that you meet the criteria to be in the study.  
   
Questionnaires: At each study visit, you will complete paper-based questionnaires about your 
general health, physical activity, and your ability to complete daily activities. These 
questionnaires are being administered for research purposes only. 
 
Magnetic Resonance Imaging (MRI) - Brain Imaging: MRI is a commonly performed 
medical procedure. In fact, about 30 million MRI scans are performed in the United States each 
year. It takes about 45 minutes to obtain these pictures. You will need to lie still inside a big 
machine. The machine will make noise, but otherwise you will not feel anything. The machine 
will use magnets and radio signals to gather information about your brain. This information will 
be used to construct a picture of how your brain looks, how much blood is flowing to different 
parts of your brain, and how much some parts of your brain are communicating with each other. 
You will undergo a MRI exam at Screening/Baseline and 24 Months. If you receive a baseline 
MRI exam as part of your standard of care imaging for your disease, this MRI exam will be used 
to satisfy the MRI screening/baseline requirement and will be considered performed for standard 
of care purposes and billable to you/your insurance company. If a baseline MRI exam needs to 
be performed for the purposes of this research study only (i.e. you have previously received an 
MRI for standard of care purposes outside the screening window and the exam must be repeated 
for research purposes or if you do not have an MRI exam on file within the screening window 
and this exam must be performed for the purposes of this study only) it will be billable to the 
study. The subsequent MRI exam performed at 24 Months is considered performed for research 
purposes only and billable to the study. 
 
PE2i Positron Emission Tomography (PET) Scan - Brain Imaging: The PE2i PET procedure 
will begin by placing an intravenous (IV) catheter in a vein in one of your forearms. A small 
amount of a specialized PET chemical (drug) will be injected into your blood stream through an 
IV catheter. The chemical has a radioactive atom on it that gives off radiation. This radiation, 
cannot be seen with the human eye, but it can be seen by PET camera. The radiation makes it 
possible for the PET camera to watch where ever the chemical goes, and see how it interacts with 
your brain. The chemical, called “PE2i” helps us see how your dopamine system is working and 


4 
WEILL CORNELL MEDICAL COLLEGE 
 
 
IRB Protocol # 
1711018740 
Consent version date:  
11/30/2021 
 
Rev 10-2014 
will bind to dopamine transporters (DaT) on the neuron. PE2i is an investigational chemical. 
This means that it has not been approved by US Food and Drug Administration (FDA) for 
general use. It has only been approved for use in research studies like this one. 
 
DaT (iuflopane) Single Photo Emission Computed Tomogrpahy (SPECT) Scan – Brain 
Imaging: The DaTSCAN procedure will begin by placing an intravenous (IV) catheter in a vein 
in one of your forearms. A small amount of a specialized SPECT chemical (drug) will be 
injected into your blood stream through an IV catheter. The chemical has a radioactive atom on it 
that gives off radiation. This radiation, cannot be seen with the human eye, but it can be seen by 
SPECT camera. The radiation makes it possible for the SPECT camera to watch where ever the 
chemical goes, and see how it interacts with your brain. The chemical, called “iuflopane” helps 
us see how your dopamine system is working. This scan has been approved by US Food and 
Drug Administration (FDA) for the indication it is being used for in this study. 
 
Lugol’s Solution: If you are receiving the DaT scan, before the scan occurs subjects will ingest 
a small amount of Lugol’s solution which is a saturated solution of potassium iodide. The 
purpose of Lugol’s before a DaT scan is to protect the thyroid from radioactive iodine. 
 
You will undergo either a PE2i PET Scan with PE2i or DaT scan at Screening/Baseline and 24 
Months. The PE2i PET scan or DaT scan performed as part of this study will be performed for 
research purposes only. 
 
Please see the schedule of events below for a summary of what to expect at each study visit: 
Screening/ Baseline Visit: 
 
During this visit we will:  
 
• Review the study, answer any questions you may have and ask you to sign this 
consent document if you wish to be a part of the study  
• Give you a subject identification number  
 
If you meet all of the requirements of the study, the tasks listed below will be done: 
• Review your medical history including your age, sex, major health events (e.g. 
hospital admissions)  
• Review your current medication use, including over the counter medications and 
herbals  
• Perform a physical and neurological exam  
• Ask you to fill out questionnaires about quality of life and other PD symptoms 
• Ask you to complete a Montreal Cognitive assessment (MoCA) test 
• If you are a woman who can get pregnant, a pregnancy test will be done using a 
urine sample.  
• Perform MRI of the brain 


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• Perform PE2i PET scan of the brain with PE2i or DaT scan with iuflopane 
 
24 Month Visit: 
• Review your current medication use, including over the counter medications and 
herbals  
• Perform a physical and neurological exam  
• Assess/Monitor your PD symptoms using various rating scales. 
• Ask you to fill out questionnaires about quality of life and other PD symptoms 
• Ask you to complete a Montreal Cognitive assessment (MoCA) test 
• If you are a woman who can get pregnant, a pregnancy test will be done using a 
urine sample.  
• Perform MRI of the brain 
• Perform PE2i PET scan of the brain with PE2i or DaT scan with iuflopane 
 
During the period of time between your screening/baseline visit and the 24 Month visit, you may 
return to the clinic for monitoring of your disease as part of your standard of care follow up 
prescribed by your treating physician.  As part of this research study, we will collect clinical 
information relating to your diagnosis which is located in your medical record.  This is called a 
research chart review, clinical information which will be collected for research purposes may 
include new medications prescribed, imaging results, and information relating to disease 
progression. 
 
HOW LONG WILL I BE IN THE STUDY? 
We think you will be in the study for 24 Months. 
 
You can stop participating at any time.  However, if you decide to stop participating in the study, we 
encourage you to talk to the study team first. 
 
If you choose to not participate in the study or to leave the study, your regular care will not be affected 
nor will your relations with WCMC, New York-Presbyterian Hospital, your physicians, or other 
personnel. In addition, you will not lose any of the benefits to which you are entitled. 
 
Withdrawal by investigator, physician, or sponsor 
 
The investigators, physicians or sponsors may stop the study or take you out of the study at any 
time should they judge that it is in your best interest to do so, if you experience a study-related 
injury, if you need additional or different medication, or if you do not comply with the study 
plan. They may remove you from the study for various other administrative and medical reasons. 
They can do this without your consent. 
 
WHAT ARE THE RISKS OF THE STUDY? 


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Risks and discomforts include: 
 
1. PE2i PET scans:  You may experience discomfort from lying still on your back for each 
scan; some people feel claustrophobic in the PET scanner. If this happens we would stop 
the scan immediately.  PE2i-PET scans are experimental studies that may be conducted 
only for medical research purposes.  PE2i-PET involves exposure to radiation, and that 
exposure is increased the more often such imaging tests are done. The PE2i tracers are 
radioactive because one of the atoms (Carbon-11) that make up the drugs has been man-
made in such a way that it will spontaneously decompose.  When it does, it will give off a 
type of radiation in the form of rays.  These special type of rays are a form of radiation that 
cannot be seen with the human eye, but the camera has sensors that can detect where it is 
coming from inside your body.  These rays will be used to make pictures of your brain. In 
this study, you may have either 2 PET scans over a 24 Month period. The total amount of 
radiation that you will be exposed to from the PET scans in this study is a little less than 
the amount of radiation exposure allowed for occupational workers over a period of one 
year.  There are always theoretical risks associated with exposure to radiation of any 
kind.  These risks are considered within acceptable limits for human subjects who will not 
personally benefit from their participation in the research study.  Tell the study doctors if 
you have participated in other research this past year that involved exposure to radiation.  
 
2. Radiation Exposure. Tests included in this study, PET (positron emission tomography) or 
SPECT (single photo emission computed tomography) nuclear medicine scans, are 
employed routinely in the care of patients with medical conditions. They involve exposure 
to radiation and that exposure is increased the more often such tests are done. Radiation 
exposure at certain doses can potentially cause cancer. Any possible increase in cancer risk 
associated with participation in this study is within acceptable limits for human research 
subjects. 
 
3. Allergic reactions.   
With any drug (radioactive chemical substance used in PE2I PET scans or DaT scans), there 
is a possibility of an allergic reaction.  Allergic reactions most commonly are mild such as a 
rash, cough, dizziness or fainting, hives, itching, chest tightness, shortness of breath, or 
wheezing.  Rarely, a more severe and possibly even life-threatening reaction can occur, such 
as anaphylaxis (a reaction which may involve shortness of breath, swelling or closing of the 
airway and/or drop in blood pressure).  In the event of an allergic reaction, medical treatment 
will be immediately available from the study staff.  The risks of an allergic reaction from 
imaging exams in this study are very low.   
 
4. IV catheter.  Before each PE2i PET scan or DaT scan study begins, a catheter will be placed 
in a vein of your forearm.  Catheter placement may cause bleeding, bruising, redness, 
swelling discomfort, and/or pain at the needle site or dizziness and fainting.  The bruising 
and discoloration at the areas where the venous catheters are inserted may last for several 
days after the study.  On rare occasions, they may cause clot formation and infection.  You 


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should discuss these risks with your study doctor.  You must notify the study physician right 
away if you have any symptoms from the catheter in your arm. 
 
5. DaT scans. The most common side effects of DaT imaging are headache, increased appetite, 
and dizziness. However, it is important for you to know that the injection of DaTscan may 
include risks that cannot be predicted, although for the purposes of this study, it is being used 
in accordance with its FDA approved usage. The insertion of the IV may feel uncomfortable 
and may leave a bruise. You will need to lie very still under the camera for up to 1 hour, 
which may be uncomfortable. The DaT scan included in this study is employed routinely in 
the care of patients with medical conditions. It involves exposure to radiation and that 
exposure is increased the more often such tests are done. Radiation exposure at certain doses 
can potentially cause cancer. Any possible increase in cancer risk associated with 
participation in this study is within acceptable limits for human research subjects. 
 
6. Lugol's Solution. Lugol's Solution is 10 drops of saturated solution of potassium iodide. You 
may experience a metallic or bitter taste in your mouth from iodine. If you have allergies to 
iodine, you must inform your study doctor. Patients with iodine allergies may experience 
itching, a rash, bloating, severe blood pressure changes (shock), or death if given iodine. If 
you are allergic to iodine, you will be administered potassium perchlorate instead of Lugol's 
solution. 
 
7. MRI scans. The MRI scan involves the use of a magnet and radiofrequency waves (much 
like an ordinary shortwave radio.) There are no known risks or adverse effects resulting 
directly from exposure to magnetic fields and radiofrequency signals used in this study, other 
than the potential risks associated with the scanning procedure summarized below: 
A. Claustrophobia. Some people feel claustrophobic in the MR scanner. If this happens we 
would stop the scan immediately. 
B. Metallic Foreign Body Risks. You may not be able to undergo MRI scanning if you have 
a pacemaker, an implanted defibrillator or certain other implanted electronic or metallic 
devices. It is important for you to advise the MRI staff if you have had brain surgery for a 
cerebral aneurysm, or if you have implanted medical or metallic devices, shrapnel, or other 
metal fragments or objects in your body, such as metal in your eye 
 
8. There may be unforeseen risks that cannot be anticipated. 
 
9. Incidental Findings. The PET or DaT scans and the MRI scans will be interpreted by a 
WCMC Department of Radiology faculty radiologist.  The report of the findings will be 
provided to the study PI.  The PET scans, DaT scans, or the MRI scans could show 
unexpected findings that seem unusual.  These findings could suggest that we have 
accidentally discovered a disease that you didn’t know you had.  If this situation occurs, we 
might recommend that you have these findings investigated in collaboration with a physician 
who is not involved in this study.  This could result in anxiety, risks unrelated to the research 


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procedures, and health care costs.  These costs are not covered by the study or WCMC, and 
therefore are the sole responsibility of the subject and or the subject’s insurance company. 
 
10. Frustration and Anxiety during clinical testing: You may feel frustrated while completing 
the study questionnaires. You are free to stop a test at any time if you feel frustrated, 
embarrassed, or if you choose not to continue.  
 
11. Loss of Confidentiality: Participation in this research carries a small risk of loss of 
confidentiality.  We will code the information we collect from you rather than using your 
name or other information that can directly identify you. Every effort will be made to 
maintain your confidential information and protect personal information obtained as a result 
of this study.  Therefore the possibility of someone obtaining your confidential information 
is low. 
 
12. Risks related to pregnancy: Women who are pregnant or nursing will not be included in the 
study. Women who can get pregnant must confirm to the best of their knowledge that they 
are not pregnant or intending to become pregnant during this study. Women who can get 
pregnant will have a pregnancy test before the start of the study.  If the test is positive during 
your Screening/Baseline visit, you will be excluded from the study.   The risk associated with 
undergoing a PE2i PET or DaT scan while pregnant are unknown. There are no known risks 
from MRI imaging during pregnancy. However, there may be risks that are currently 
unknown. Therefore, the study team will take all precautions to verify that you are not 
pregnant at the time of undergoing this imaging test. If you decide you wish to become 
pregnant you must notify the study team immediately. 
 
ARE THERE ANY BENEFITS TO TAKING PART IN THE STUDY? 
 
We cannot and do not guarantee that you will receive any benefits from the study. We hope the 
information learned from this study will benefit other patients with Parkinson’s disease and 
RBD and improve inclusion criteria for future clinical trials. 
 
WHAT OTHER OPTIONS ARE THERE? 
Instead of being in this study, you have these options: 
You may choose not to participate. Choosing not to participate will not impact your care at New York 
Presbyterian Weill Cornell Medicine. 
WHAT ABOUT CONFIDENTIALITY? 
Efforts will be made to protect your medical records and other personal information to the extent 
allowed by law. However, we cannot guarantee absolute confidentiality.  Records of study participants 
are stored and kept according to legal requirements and may be part of your medical record. You will 
not be identified personally in any reports or publications resulting from this study. Organizations that 
may request to inspect and/or copy your research and medical records for quality assurance and data 
analysis include groups such as: 


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• Weill Cornell Medical College and New York-Presbyterian Hospital 
• Hospital for Special Surgery 
• The Institutional Review Board (IRB) 
• The Office of Human Research Protection (OHRP) 
• Department of Health and Human Services and National Institutes of Health 
• The Food and Drug Administration (FDA) and/or their representatives  
• National Institutes of Health (NIH) 
 
By signing this consent form, you authorize access to this confidential information.  You also 
authorize the release of your medical records to Weill Cornell Medical College and New York-
Presbyterian Hospital by any other hospitals or institutions where you might receive medical care 
of any kind while you are participating in this study.   
If information about your participation in this study is stored in a computer, we will take 
precautions to protect it from unauthorized disclosure, tampering, or damage by requiring a 
unique ID and password to log into the database. Each participant will have a personal folder 
containing all relevant documents (consent forms, contact information, etc.), which will be stored 
locked in the Department of Radiology offices. Data will be entered into a dedicated study research 
database that is password protected. In addition, only personnel who are associated with the study 
will have access to the study specific records in the database. 
Please also note that your MRI and PET or SPECT imaging that are done as part of this study 
will be read and interpreted by a WCMC Department of Radiology radiologist and the report will 
be provided to the Principal Investigator.  If there are any unsuspected, incidental findings that 
you should know about, the Principal Investigator will share the findings with you or a physician 
who you may designate. Incidental findings noted on the MRI and PET or SPECT studies might 
or might not have clinical significance and might or might not lead to further medical tests or 
treatments.  It will be up to you and your designated physician to determine if any further testing 
or treatment is necessary on the basis of this information. 
 
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by 
U.S. Law. This website will not include information that can identify you.  At most, the website will 
include a summary of the results.  You can search this website at any time. 
 
 
HIPAA AUTHORIZATION TO USE or DISCLOSE PROTECTED HEALTH 
INFORMATION FOR RESEARCH 
Purposes for Using or Sharing Protected Health Information: If you decide to join this study, 
WCMC researchers need your permission to use your protected health information.  If you give 
permission, Weill Cornell Medical College (WCMC) and/or New York-Presbyterian Hospital 


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(NYPH) researchers may use your information or share (disclose) information about you for their 
research that is considered to be protected health information.  
Voluntary Choice: The choice to give WCMC and/or NYPH researcher’s permission to use or 
share your protected health information for their research is voluntary.  It is completely up to you.  
No one can force you to give permission.  However, you must give permission for WCMC and/or 
NYPH researchers to use or share your protected health information if you want to participate in 
the study. If you decline to sign this form, you cannot participate in this study, because the 
researchers will not be able to obtain and/or use the information they need in order to conduct 
their research. Refusing to give permission will not affect your ability to get usual treatment, or 
health care from WCMC and/or NYPH. 
Protected Health Information To Be Used or Shared:  Government rules require that 
researchers get your permission (authorization) to use or share your protected health information. 
Your medical information may be disclosed to authorized public health or government officials 
for public health activities when required or authorized by law. If you give permission, the 
researchers could use or share with the entities identified above any protected health information 
related to this research study from your medical records and from any test results, which includes 
the results of MRI and PET or SPECT scanning. 
 
Other Use and Sharing of Protected Health Information: If you give permission, the 
researchers could also use your protected health information to develop new procedures or 
commercial products. They could share your protected health information with the WCMC 
Institutional Review Board, inspectors who check the research, government agencies and 
research study staff. The information that may be shared with the sponsor and/or government 
agencies could include your medical record and your research record related to this study. They 
may not be considered covered entities under the Privacy Rule and your information would not 
be subject to protections under the Privacy Rule.  
 
Future Research   
You may agree to allow your data to be used for future research either within or outside WCMC 
and/or NYPH. If information goes to an outside entity then the privacy rule may not apply.  
    
RESEARCH REPOSITORY  
What is a Research Repository?  A research repository (database) is a collection of information 
from the health and medical records of many individuals. The repository (database) may share the 
information with researchers who study medical conditions and diseases.  
The repository (database) includes codes that identify each person whose information is collected.  
However, the repository does not share information with researchers unless the researchers 
promise to keep the information confidential. 


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RESEARCH PARTICIPANT: Please check the boxes below that describe your wishes: 
 
   The WCMC Repository may keep my protected health information and share it with 
qualified researchers studying the research described above.  If information goes to an 
outside entity then the Privacy Rule may not apply.  
 
    The WCMC Repository may not keep my protected health information for a research 
repository. If you do not allow your PHI to be stored in a repository, you are not eligible 
for this study.  Your health care will not be adversely impacted in any way. 
 
CANCELING AUTHORIZATION  
Canceling Permission:  If you give the WCMC and/or NYPH researchers’ permission to use or 
share your protected health information, you have the right to cancel your permission whenever 
you want. However, canceling your permission will not apply to information that the 
researchers have already used or shared. 
 
If you wish to cancel your permission, you may do so at any time by writing to: 
 
Privacy Officer 
1300 York Avenue, Box 303 
New York, NY 10065 
 
If you have questions about this, call: (646) 962-6930 or e-mail: privacy@med.cornell.edu 
End of Permission: Unless you cancel it, permission for WCMC and/or NYPH researchers to 
use or share your protected health information for their research will never end. 
 
ACCESS TO RESEARCH RECORDS During the course of this study, you will have access to 
see or copy your protected health information as described in this authorization form in 
accordance with Weill Cornell Medical College (WCMC) and/or New York-Presbyterian 
Hospital (NYPH) policies. During your participation in this study, you will have access to your 
research record and any study information that is part of that record. You will have access to 
your clinical medical record, which is kept as part of your health record within the hospital’s 
electronic medical records systems. 
WHAT ARE THE COSTS? 
You or your insurance company will have to pay for in-office physician visits performed at Baseline, 
and 24 Months if these visits are performed as standard of care. If the study Baseline/screening in-
office visit or the study 24 Month in-office visit does not coincide with a standard of care office visit, 
these visits will be billable to the study.  If you receive a baseline MRI exam as part of your 
standard of care imaging for your disease within the screening window, this MRI exam will be 
used to satisfy the MRI screening/baseline requirement and will be considered performed for 
standard of care purposes and billable to you/your insurance company.  If a baseline MRI exam 


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needs to be performed for the purposes of this research study only (i.e. you have previously 
received an MRI for standard of care purposes outside the screening window and the exam must 
be repeated for research purposes or if you do not have an MRI exam on file within the screening 
window and this exam must be performed for the purposes of this study only) it will be billable 
to the study.   
 
The following procedures are considered performed for research purposes and will be provided 
at no cost to you:  PE2i PET Brain Scan or DaT scan performed at Baseline, and Month 24 visit; 
MRI Brain performed at Baseline (see above exception for standard of care MRI exams 
performed at screening/baseline), 24 Month visits.  
 
 If unsuspected, incidental findings are noted in the review of the MRI and PET or SPECT 
studies and further medical tests and/or treatments are considered, such tests and/or treatments 
are no longer considered part of the study and therefore would be billed to you or your insurer. 
You should expect no compensation or reimbursement for these costs or any risks and anxieties 
associated with any such follow up care.  You or your insurance company will also be charged 
for any continuing medical care and/or hospitalization that are not a part of the study. 
The Policy and Procedure for Weill Cornell Medical College are as follows: 
We are obligated to inform you about WCMC’s policy in the event injury occurs.  If, as a result of 
your participation, you experience injury from known or unknown risks of the research procedures as 
described, immediate medical care and treatment, including hospitalization, if necessary, will be 
available at the usual charge for such treatment.  No monetary compensation is available from 
WCMC or New York-Presbyterian Hospital.  Further information can be obtained by calling the 
Institutional Review Board at (646) 962-8200. 
COMPENSATION FOR PARTICIPATION 
You will receive compensation for participating in this study.  
You will receive $25 dollars at the MRI scanning appointment performed at 24 Months. If you are 
asked to undergo a repeat research MRI at baseline visit, you will not be provided with 
compensation for this baseline MRI visit. You will receive $100 dollars at each PE2I PET or DaT 
scanning appointment performed at screening/baseline and 24 Months. The total compensation for 
participation in this study is up to amount of $225 dollars. 
 
You may be eligible to receive some reimbursement for your travel expenses, depending on the 
distance you travel to come to the study site. You will be required to obtain approval in advance, and 
provide the study coordinator with receipts of your travel expenses. Please ask the researchers for 
additional information. 
You should not expect anyone to pay you for pain, worry, lost income, or non-medical care costs that 
occur from taking part in this research study. 
COMMERCIAL INTEREST The Cornell Center for Technology Licensing has a patent on the 
MRI methods being used in this study.  Dr. Wang is a named inventor on the patent.   


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Dr. Wang is a named inventor on the patent on the MRI methods being used in this study. The related 
QSM technology patents are owned by Cornell University and have been licensed to 
Medimagemetric. Dr. Wang holds equity in Medimagemetric. Cornell also owns equity in 
Medimagemetric and thus has a financial interest in the outcome of this study. Dr. Kelly Gillen is a 
paid consultant for MedImageMetric. 
If you have any questions or would like additional information about the financial interests described 
in this paragraph, please contact Weill Cornell Medical College’s Office of Research Integrity at (646) 
962-8200. 
WHAT ARE MY RIGHTS AS A PARTICIPANT? 
Taking part in this study is voluntary. You may choose to not take part in the study or to leave the 
study at any time. If you choose to not participate in the study or to leave the study, your regular care 
will not be affected nor will your relations with the Weill Cornell Medical College, New York-
Presbyterian Hospital, your physicians, or other personnel.  In addition, you will not lose any of the 
benefits to which you are entitled.   
We will tell you about new information that may affect your health, welfare, or participation in this 
study. 
WHOM DO I CALL IF I HAVE QUESTIONS OR PROBLEMS? 
For questions about the study, a research-related injury, any problems, unexpected physical or 
psychological discomforts, or if you think that something unusual or unexpected is happening, call Dr. 
Alexander Shtilbans at 212-746-2474 or the Department of Neurology. Be sure to inform the 
physician of your participation in this study. 
If you have questions about your rights as a research participant, contact the WCMC IRB 
Office.  Direct your questions to:  
 
Institutional Review Board at: 
 
Address:  1300 York Avenue  
 
 
 
Box 89 
New York, New York 10065  
              
 
 
 
      Telephone:  (646) 962-8200 
Consent for Follow-Up Contact 
We would like permission to contact you annually to update your contact information. We may 
contact you in the future should we decide that it is important to continue following your 
progress or if we open a new study to follow-up on people who take part in this study. Any new 
studies would go through ethics review (just like this one) and would have a new consent form 
for you to sign. You can decide at that time whether or not you would like to participate in any 
additional studies. 
 
Please check Yes or No to indicate your preference: 


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       Yes, I give my consent to be contacted in the future. 
 
       No, I do not want to be contacted in the future. 


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Consent for Research Study 
Project Title: Quantitative Mapping of Substantia Nigra Iron in Parkinson's Disease (Stages I-
IV, REM sleep behavior disorder) and Controls 
 
Principal Investigators:  
Alexander Shtilbans, MD (Department of Neurology) 
 
RESEARCHER’S STATEMENT 
I have fully explained this study to the subject.  As a representative of this study, I have explained the 
purpose, the procedures, the benefits and risks that are involved in this research study. Any questions 
that have been raised have been answered to the individual’s satisfaction. 
 
Signature of person obtaining the consent 
Print Name of Person  
                Date 
(Principal Investigator or Co-investigator) 
 
SUBJECT’S STATEMENT 
I, the undersigned, have been informed about this study’s purpose, procedures, possible benefits and 
risks, and I have received a copy of this consent. I have been given the opportunity to ask questions 
before I sign, and I have been told that I can ask other questions at any time. I voluntarily agree to 
participate in this study. I am free to withdraw from the study at any time without need to justify my 
decision. This withdrawal will not in any way affect my future treatment or medical management and 
I will not lose any benefits to which I otherwise am entitled. I agree to cooperate with Dr. Alexander 
Shtilbans and the research staff and to inform them immediately if I experience any unexpected or 
unusual symptoms. 
 
Signature of Subject                                                    Print Name of Subject 
 
Date