PET Study of Non-Motor Symptoms of Parkinson Disease

Sponsor
University of Michigan (Other)
Overall Status
Completed
CT.gov ID
NCT01565473
Collaborator
(none)
242
1
69.9
3.5

Study Details

Study Description

Brief Summary

This research plan is focused on neurochemical positron emission tomography (PET) studies of Parkinson disease (PD). PD is the most common neurodegenerative movement disorder, and considerable progress has been made in understanding and treating the "typical" movement abnormalities of resting tremor, bradykinesia and rigidity. These cardinal PD features are all initially responsive to dopamine replacement therapy, and have been investigated intensively with respect to their relationships to degeneration of the nigrostriatal dopamine projection. More recently, increased attention has focused on the "non-motor" clinical aspects of PD, including cognitive, mood, chronobiological and peripheral autonomic defects. These clinical features are less reliably affected by dopaminergic therapy, and are likely to be associated with other, non-dopaminergic neural degenerations. Indeed, detailed postmortem assessments of PD brain reveal substantial neuronal losses in a variety of chemically-defined neurons, including brainstem serotonin and norepinephrine neurons and basal forebrain cholinergic neurons. Projects in the proposal will focus on dementia, depression, sleep-apnea and dysautonomia in PD patients, employing PET measures of presynaptic dopaminergic, serotoninergic and cholinergic CNS neurons and of peripheral sympathetic neurons. Results of the investigations may identify associations of non-motor PD signs and symptoms with the non-dopaminergic neuronal losses. These findings will establish additional therapeutic targets for symptomatic, but also for potential neuroprotective PD therapies. In addition, a majority of patients will be characterized with all 3 CNS PET measures. The availability of multiple markers of distinct neuronal populations involved in PD neurodegeneration will permit exploratory analyses to assess whether the degenerations are correlated (possibly manifestations of a common pathophysiology) or apparently independent (possibly a manifestation of multiple PD subtypes or pathophysiologies). Ultimately, better understanding of these non-motor features will be essential to developing future treatments that address the entire PD patient.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Participating subjects may be eligible for one or more of the sub-projects that may have a focus on cognition, mood, sleep or autonomic symptoms.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    242 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Cross-Sectional
    Official Title:
    PET Study of Biochemistry and Metabolism of the CNS: Parkinson Disease
    Study Start Date :
    Sep 1, 2008
    Actual Primary Completion Date :
    Jul 1, 2014
    Actual Study Completion Date :
    Jul 1, 2014

    Arms and Interventions

    Arm Intervention/Treatment
    Parkinson disease patients

    Healthy normal controls

    Outcome Measures

    Primary Outcome Measures

    1. To asses the non-motor aspects of PD [at initial visit and at 2 years for memory (PIB) and autonomic system symptoms (DTBZ and HED)]

      The non-motor aspects that were studied included, sleep disorders, depression, memory, and autonomic system symptom.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • age 50 and above (40 for Normal Control population)

    • diagnosed with PD

    • Hoehn & Yahr 1-4,

    Exclusion Criteria:
    • other disorders which may resemble PD

    • unstable medical conditions

    • significant neurological or psychiatric disorders

    • taking certain medications such as acetylcholinesterase inhibitors, neuroleptics, psychostimulants, tricyclic antidepressants,

    • contraindication to MRI (pacemakers, metal in eye, etc)

    • recent exposure to significant amount of ionizing radiation

    • pregnancy

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Michigan Health System Ann Arbor Michigan United States 48109

    Sponsors and Collaborators

    • University of Michigan

    Investigators

    • Study Director: Nicolaas Bohnen, M.D., Ph.D., University of Michigan
    • Principal Investigator: Kirk Frey, M.D., Ph.D., University of Michigan

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Nicolaas Bohnen, MD, PhD, M.D., Ph.D., University of Michigan
    ClinicalTrials.gov Identifier:
    NCT01565473
    Other Study ID Numbers:
    • P01NS015655
    First Posted:
    Mar 28, 2012
    Last Update Posted:
    Dec 2, 2014
    Last Verified:
    Dec 1, 2014
    Keywords provided by Nicolaas Bohnen, MD, PhD, M.D., Ph.D., University of Michigan
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Dec 2, 2014