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

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.

Inclusion Criteria:

- 1. Idiopathic Parkinson's Disease, REM Sleep Behavior Disorder subjects without signs
of Parkinsonism and normal healthy controls a. If tremor is not present, subjects must
have unilateral onset and persistent asymmetry of the symptoms. b. For PD Subjects
only: Age > 30 years at time of diagnosis of PD with a maximum age of 100 years old c.
Hoehn & Yahr stage < V (if PD)

- 2. For PD subjects only: Receiving an optimized dopaminergic regimen (i.e., either
MAO-B inhibitor, a dopamine agonist and/or low doses of L-dopa, with dose change no
more frequent than every 6-month in the course of the study); or medications naive

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

- 4. Deemed healthy and able to undergo MRI and PE2i PET imaging by the Site
Investigator, based on screening assessments-- medical history, physical examination
5. For Controls & REM Sleep Behavior Disorder Subjects Only: Age 20-80; willing to
undergo multiple imaging sessions 6. Signed informed consent form

Exclusion Criteria:

- 1. Patient with atypical parkinsonism (such as suspected Progressive Supranuclear
Palsy, Multiple System Atrophy) and secondary parkinsonism (such as normal pressure
hydrocephalus, drug-induced, or vascular parkinsonism)

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

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

- 4. Patients with clinically significant depression as determined by the Beck
depression score > 15

- 5. History of exposure to typical or atypical neuroleptics or any dopamine blocking
agent within 6 months prior to enrollment

- 6. Patients with psychosis/active hallucinations and memory difficulty pre-dating the
onset of motor symptoms

- 7. History of brain surgery for PD

- 8. History of thyroid disease

- 9. History of stroke or cerebral vascular disease

- 10. History of drug abuse

- 11. History of repeated head injury or encephalitis

- 12. Positive dementia by DSM IV-R

- 13. Women of childbearing potential who are not surgically sterilized have to use a
reliable measure of contraception and have a negative urine pregnancy test at the
screening

- 14. Participation in other investigational drug trials within 30 days prior to
screening

- 15. Contraindication for receiving MRI imaging such as presence of pacemakers, certain
types of metallic implants, severe claustrophobia, history of reaction to contrast
material, or renal insufficiency