Imaging the Dopamine Transporter in Parkinson's Disease
- Study HIC#:2000023896
- Last Updated:07/15/2021
You are invited to participate in a research study designed to evaluate neuronal density and dopamine in Parkinson’s Disease and in healthy subjects using PET scans. You have been asked to participate because you are between the ages of 40-70 and have been diagnosed with Parkinson’s Disease. Up to 30 people will be asked to participate in this study.
- Age40 years and older
- Start Date03/11/2019
- End Date12/31/2020
Trial Purpose and Description
We propose to use positron emission tomography (PET) imaging to examine in vivo measurement of the dopamine transporter (DAT), a marker of presynaptic nigrostriatal dopaminergic terminal degeneration, in Parkinson s Disease (PD) and Healthy Control (HC) subjects.
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
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 work place 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).