Imaging Biomarkers of Progression of Mobility Impairment in Parkinson Disease
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Parkinson's Disease
- Sponsor
- VA Office of Research and Development
- Enrollment
- 67
- Locations
- 1
- Primary Endpoint
- AChE PET Neuroimaging
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
The purpose of this research is to evaluate changes in cholinergic brain activity over time in subjects with Parkinson disease.
Detailed 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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
AChE PET Neuroimaging
Time Frame: 4 yr
AChE PMP PET hydrolysis rate outcome measure. AChE \[11C\]PMP hydrolysis rates (k3) were estimated using the striatal volume of interest (defined by manual tracing on the MRI scan of the putamen and caudate nucleus) as the tissue reference for the integral of the precursor delivery. This measure is a proxy measure for the count of cholinergic nerve terminals in the basal forebrain innervation the cortical mantle.