Imaging Biomarkers of Progression of Mobility Impairment in Parkinson Disease

Completed

• Conditions: Parkinson's Disease

• Registration Number: NCT01106976
• Lead Sponsor: VA Office of Research and Development

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.

Study Timeline

• Study First Submitted: 2010-04-14
• Study First Submitted QC: 2010-04-19
• Study First Posted: 2010-04-20
• Study Start: 2010-05
• Primary Completion: 2014-09
• Study Completion: 2015-03
• Results First Submitted: 2015-11-06
• Status Verified: 2015-12
• Results First Submitted QC: 2015-12-23
• Last Update Submitted: 2015-12-23
• Results First Posted: 2016-02-01
• Last Update Posted: 2016-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 67

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
AChE PET Neuroimaging	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.

Trial Locations

Locations (1)

VA Ann Arbor Healthcare System, Ann Arbor, MI; 🇺🇸 Ann Arbor, Michigan, United States