PET Study of Non-Motor Symptoms of Parkinson Disease

NCT01565473 | Completed

• 1 other identifier: P01NS015655
• Study Type: observational
• Target: 242
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Keywords

non-motor symptoms

Outcome Measures

Primary Outcomes (1)

• To asses the non-motor aspects of PD

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

  at initial visit and at 2 years for memory (PIB) and autonomic system symptoms (DTBZ and HED)

Study Arms (2)

Parkinson disease patients

Healthy normal controls

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Movement Disorders Clinic, Hospital, Primary Care, Community

You may qualify if:

• age 50 and above (40 for Normal Control population)
• diagnosed with PD
• Hoehn \& Yahr 1-4,

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan Health System

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (1)

• 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.

  PMID: 31732566 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood Saliva

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Nicolaas Bohnen, M.D., Ph.D.

  University of Michigan

  STUDY DIRECTOR

• Kirk Frey, M.D., Ph.D.

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., Ph.D.

Study Record Dates

• First Submitted: March 26, 2012
• First Posted: March 28, 2012
• Study Start: September 1, 2008
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: December 2, 2014

Record last verified: 2014-12

Locations

US (1)