Measuring Parkinson's Disease Progression

• Status: Completed
• Trial end date: 2019-10-19
• Target enrollment: 0
• Participant gender: All

Summary

The Measuring Parkinson's Disease Progression study aims to use MRI scans and a controlled dose of levodopa to find a biomarker (objective measurement) of Parkinson's disease (PD). Biomarkers would help determine the effectiveness of therapies in slowing or stopping PD progression, and accelerate the pace of research.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kevin J. Black, MD
• Collaborator: The Michael J. Fox Foundation for Parkinson's Research
• Treatments: Carbidopa; Levodopa

Criteria

Inclusion Criteria:

• Age 40-79 at screening

• Meet accepted diagnostic criteria for Parkinson disease

Exclusion Criteria: Key exclusion criteria:

• Deep brain stimulator (DBS)

• Pregnancy

• Patients taking a dopamine antagonist (like quetiapine) or dopamine partial agonist (like aripiprazole)

• Metal in the head or eye, or other contraindication to MRI

• Claustrophobia

• Serious neurologic disease other than PD

• Head trauma with loss of consciousness for more than 5 minutes

• Severe or unstable systemic illness

• Certain psychiatric illnesses (dementia, psychosis, current major depression)

• Current alcohol use disorder

• Subjects who feel that going without nicotine for 3-4 hours would be uncomfortable

• Currently taking an extended-release formulation of a dopamine agonist (like Mirapex ER or Requip XL)