Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

PET Study of Non-Motor Symptoms of Parkinson Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date March 26, 2012
First Posted Date March 28, 2012
Last Update Posted Date December 2, 2014
Study Start Date September 2008
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 1, 2014)
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.
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title PET Study of Non-Motor Symptoms of Parkinson Disease
Official Title PET Study of Biochemistry and Metabolism of the CNS: Parkinson Disease
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.
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 Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Whole blood Saliva
Sampling Method Non-Probability Sample
Study Population Movement Disorders Clinic, Hospital, Primary Care, Community
Condition Parkinson Disease
Intervention Not Provided
Study Groups/Cohorts
  • Parkinson disease patients
  • Healthy normal controls
Publications * Zhou Z, Müller MLTM, Kanel P, Chua J, Kotagal V, Kaufer DI, Albin RL, Frey KA, Bohnen NI. Apathy rating scores and β-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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: December 1, 2014)
242
Original Estimated Enrollment
 (submitted: March 26, 2012)
250
Actual Study Completion Date July 2014
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01565473
Other Study ID Numbers P01NS015655( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Nicolaas Bohnen, MD, PhD, University of Michigan
Study Sponsor University of Michigan
Collaborators Not Provided
Investigators
Study Director: Nicolaas Bohnen, M.D., Ph.D. University of Michigan
Principal Investigator: Kirk Frey, M.D., Ph.D. University of Michigan
PRS Account University of Michigan
Verification Date December 2014