Imaging Biomarkers of Progression of Mobility Impairment in Parkinson Disease

This study has been completed.
Sponsor:
Collaborator:
University of Michigan
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT01106976
First received: April 14, 2010
Last updated: December 23, 2015
Last verified: December 2015
  Purpose
The purpose of this research is to evaluate changes in cholinergic brain activity over time in subjects with Parkinson disease.

Condition
Parkinson's Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Imaging Biomarkers of Progression of Mobility Impairment in Parkinson Disease

Resource links provided by NLM:


Further study details as provided by VA Office of Research and Development:

Primary Outcome Measures:
  • AChE PET Neuroimaging [ Time Frame: 4 yr ] [ Designated as safety issue: No ]
    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.


Biospecimen Retention:   None Retained
Saliva

Enrollment: 67
Study Start Date: May 2010
Study Completion Date: March 2015
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Group 1 Parkinson disease subjects
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.

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.
  Eligibility

Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Recruited in previous study
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01106976

Locations
United States, Michigan
VA Ann Arbor Healthcare System, Ann Arbor, MI
Ann Arbor, Michigan, United States, 48105
Sponsors and Collaborators
VA Office of Research and Development
University of Michigan
Investigators
Principal Investigator: Nicolaas I Bohnen, MD PhD VA Ann Arbor Healthcare System, Ann Arbor, MI
  More Information

Publications:
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01106976     History of Changes
Other Study ID Numbers: E7285-R 
Study First Received: April 14, 2010
Results First Received: November 6, 2015
Last Updated: December 23, 2015
Health Authority: United States: Federal Government

Keywords provided by VA Office of Research and Development:
PET
acetylcholine

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on August 24, 2016