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PET Study of Non-Motor Symptoms of Parkinson Disease

NCT ID: NCT01565473

Last Updated: 2014-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

242 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-09-30

Study Completion Date

2014-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Parkinson Disease

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Parkinson disease patients

No interventions assigned to this group

Healthy normal controls

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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Nicolaas Bohnen, MD, PhD

M.D., Ph.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nicolaas Bohnen, M.D., Ph.D.

Role: STUDY_DIRECTOR

University of Michigan

Kirk Frey, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

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University of Michigan Health System

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

References

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Zhou Z, Muller MLTM, Kanel P, Chua J, Kotagal V, Kaufer DI, Albin RL, Frey KA, Bohnen NI. Apathy rating scores and beta-amyloidopathy in patients with Parkinson disease at risk for cognitive decline. Neurology. 2020 Jan 28;94(4):e376-e383. doi: 10.1212/WNL.0000000000008683. Epub 2019 Nov 15.

Reference Type DERIVED
PMID: 31732566 (View on PubMed)

Other Identifiers

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P01NS015655

Identifier Type: NIH

Identifier Source: org_study_id

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