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PET Study of Non-Motor Symptoms of Parkinson Disease

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ClinicalTrials.gov Identifier: NCT01565473
Recruitment Status : Completed
First Posted : March 28, 2012
Last Update Posted : December 2, 2014
Sponsor:
Information provided by (Responsible Party):
Nicolaas Bohnen, MD, PhD, University of Michigan

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
Parkinson Disease

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.

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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 : September 2008
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine


Group/Cohort
Parkinson disease patients
Healthy normal controls



Primary Outcome Measures :
  1. To asses the non-motor aspects of PD [ Time Frame: 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.


Biospecimen Retention:   Samples With DNA
Whole blood Saliva


Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Movement Disorders Clinic, Hospital, Primary Care, Community
Criteria

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

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): NCT01565473


Locations
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United States, Michigan
University of Michigan Health System
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Investigators
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Study Director: Nicolaas Bohnen, M.D., Ph.D. University of Michigan
Principal Investigator: Kirk Frey, M.D., Ph.D. University of Michigan
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Nicolaas Bohnen, MD, PhD, M.D., Ph.D., University of Michigan
ClinicalTrials.gov Identifier: NCT01565473    
Other Study ID Numbers: P01NS015655 ( U.S. NIH Grant/Contract )
First Posted: March 28, 2012    Key Record Dates
Last Update Posted: December 2, 2014
Last Verified: December 2014
Keywords provided by Nicolaas Bohnen, MD, PhD, University of Michigan:
non-motor symptoms
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases