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Imaging Biomarkers of Progression of Mobility Impairment in Parkinson Disease

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ClinicalTrials.gov Identifier: NCT01106976
Recruitment Status : Completed
First Posted : April 20, 2010
Results First Posted : February 1, 2016
Last Update Posted : February 1, 2016
Sponsor:
Collaborator:
Information provided by (Responsible Party):

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

Condition or disease
Parkinson's 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 Design

Study Type : Observational
Actual Enrollment : 67 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Imaging Biomarkers of Progression of Mobility Impairment in Parkinson Disease
Study Start Date : May 2010
Primary Completion Date : September 2014
Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
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.


Outcome Measures

Primary Outcome Measures :
  1. 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.


Biospecimen Retention:   None Retained
Saliva

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Posted: April 20, 2010    Key Record Dates
Results First Posted: February 1, 2016
Last Update Posted: February 1, 2016
Last Verified: December 2015

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