Longitudinal changes in Parkinson’s disease (PD) via positron emission tomography (PET)

The purpose of this research study is to evaluate neuronal density and dopamine in Parkinson’s Disease using Positron Emission Tomography (PET) scans. We will use radioactive compounds (or radiotracers) called [11C]APP311 and/or [18F] FE-PE2I. The first of which attaches to the SV2A protein in the brain, a marker of synaptic density, the second a measure of the Dopamine Transporter (DAT) in the brain.

This study has 2 parts:

• Aim 1: One [11C]APP311 scan and/or one [18F] FE-PE2I scan;
• Aim 2: One longitudinal [11C]APP311 scan and/or one longitudinal [18F] FE-PE2I scan).

If you complete Aim 1, you will be asked to return one to four years later for additional PET scans (Aim 2). This will allow us to look at differences between the scans to see how your synaptic density and dopamine transporter has changed over time. The PET study procedures for Aims 1 & 2 are the same.

Study procedures will include a screening appointment, a magnetic resonance imaging (MRI) scan, and one positron emission tomography (PET) scanning session for each of the above radiotracers

Inclusion Criteria:

1) Age 40-80 years

2) Voluntary, written, informed consent

3) Physically healthy by medical history, physical, ECG and laboratory examinations

4) For females, non‐lactating, no longer of child-bearing potential or agree to practice effective contraception during the study, as well as a negative serum pregnancy (β-HCG) test at screening, and negative urine pregnancy on PET scanning days.

5) For Parkinson’s patients, clinical diagnosis of PD, able to consent and tolerate PET scanning procedures

Exclusion Criteria:

1) A history of substance dependence (e.g., alcohol, nicotine, opiates, sedative hypnotics, etc.), except for nicotine (confirmed by self-report)

2) A significant DSM-5 psychiatric disorder (as determined by the psychiatric exam or Structured Clinical Interview for DSM-IV or SCID)

3) A history of significant medical (e.g., cardiovascular, renal) or neurological (e.g., cerebrovascular, seizure, traumatic brain injury) illness other than PD that is unstable and/or might effect the study objectives.

4) Subjects with history of prior radiation exposure for research purposes within the past year such that participation in this study would place them over FDA limits for annual radiation exposure. This guideline is an effective dose of 5 rem received per year.

5) Subjects with current, past or anticipated exposure to radiation in the workplace within one year of proposed research PET scans that in combination with the study tracer would result in a cumulative exposure that exceeds recommended exposure limits.

6) Medical contraindications to participation in a magnetic resonance imaging procedure (e.g., ferromagnetic implants/foreign bodies, claustrophobia, cardiac pacemaker, prosthetic valve, otologic implant, etc.)

7) History of a bleeding disorder or are currently taking anticoagulants (such as Coumadin, Heparin, Pradaxa, Xarelto).