Imaging Biomarkers of Progression of Mobility Impairment in Parkinson Disease

VA Office of Research and Development

Status: Completed

Conditions: Parkinson's Disease

Study type: Observational

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT01106976

E7285-R

Details and patient eligibility

About

The purpose of this research is to evaluate changes in cholinergic brain activity over time in subjects with Parkinson disease.

Full description

The project will apply positron emission tomography (PET) of acetylcholinesterase to study non-dopaminergic (i.e. cholinergic) brain changes over time in subjects with Parkinson disease. Acetylcholinesterase PET imaging was used to assess cholinergic changes over time in this study. Acetylcholinesterase PET imaging is a diagnostic test as the investigator does not assign specific interventions to the subjects of the study based on the acetylcholinesterase PET. Therefore, this is an observational study as defined as following: studies in human beings in which biomedical and/or health outcomes are assessed in pre-defined groups of individuals. Subjects in the study may receive diagnostic, therapeutic, or other interventions, but the investigator does not assign specific interventions to the subjects of the study.

Enrollment: 67 patients

Sex: All

Ages: 50+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients who meet the UK Parkinson's Disease Society Brain Bank Research Center clinical diagnostic criteria for PD.
• Hoehn and Yahr stages 1-2.5 at initial recruitment in baseline study.
• Absence of dementia confirmed by neuropsychological testing at initial recruitment in baseline study.

Exclusion criteria

• contra-indication for magnetic resonance study
• Pregnancy or breastfeeding

Trial design

67 participants in 1 patient group

Group 1 Parkinson disease subjects

Description:

Subjects with Parkinson disease who previously participate in a motor and brain PET (brain positron emission tomography) imaging study who were invited for a longitudinal observational study.