Serotonin and Amyloidopathy
Primary Purpose
Parkinson's Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PET imaging
Sponsored by
About this trial
This is an interventional diagnostic trial for Parkinson's Disease
Eligibility Criteria
Inclusion Criteria:
- Persons who have been diagnosed with Parkinson disease age 45 years and older are eligible to participate in this study.
- Healthy older individuals (ages 60-80) without neurologic problems are eligible to participate.
Exclusion Criteria:
- Individuals using some drugs cannot participate. These include anti-depressant medications, buproprion, or St. John's Wort, as well as dopamine antagonist medications.
- Women of childbearing age may not participate.
- Individuals unable to have MRI scans because of a pacemaker or metal fragments may not participate.
- Individuals with a history of stroke may not participate. People with any contraindication of PET imaging such as previous participation in research procedures involving ionizing radiation may not be eligible to participate in this study.
Sites / Locations
- University of Michigan Health System
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Case
Control
Arm Description
Patients with diagnosed Parkinson's disease
Healthy adults
Outcomes
Primary Outcome Measures
Regional brain beta amyloid levels and regional brain serotonin terminal density as measured by PET brain imaging.
The PET imaging measures of regional brain beta amyloid levels and regional serotonin terminal density will be compared across participants to determine if there is a relationship between the regional density of serotonin terminals and the accumulation of beta amyloid.
Secondary Outcome Measures
Full Information
NCT ID
NCT02895932
First Posted
December 1, 2015
Last Updated
August 31, 2018
Sponsor
University of Michigan
1. Study Identification
Unique Protocol Identification Number
NCT02895932
Brief Title
Serotonin and Amyloidopathy
Official Title
Serotonin and Amyloidopathy
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
January 2015 (Actual)
Primary Completion Date
October 2017 (Actual)
Study Completion Date
October 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to determine if changes in brain serotonin affects the accumulation of amyloid in the brain. The investigators will use brain imaging methods to measure the amount of serotonin and amyloid in the brain of individuals with Parkinson's Disease (PD) and otherwise healthy older people. PD participants will undergo repeat brain imaging to assess amyloid accumulation two years after their first brain imaging session. All participants will undergo examinations to assess their motor function, and asked questions to assess their mood and thinking.
Detailed Description
Parkinson's disease (PD) is a common problem of older people often causing significant problems with thinking and memory. Abnormal accumulation within in the brain of a protein called amyloid is felt to contribute to impaired thinking and memory in PD. Excessive accumulation of this protein is also involved in Alzheimer disease (AD) and may influence thinking and memory in otherwise healthy older people. Recent evidence suggests that changes in the amount of another brain chemical, serotonin, influences the amount of amyloid accumulating in the brains of people with PD and otherwise healthy older people. The purpose of this study is to determine if changes in brain serotonin affects the accumulation of amyloid in the brain. The investigators use brain imaging methods to measure the amount of serotonin and amyloid in the brain of individuals with PD and otherwise healthy older people. PD participants will undergo repeat brain imaging to assess amyloid accumulation 2 years after their first brain imaging session. All participants will undergo examinations to assess their motor function, and asked questions to assess their mood and thinking.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Case
Arm Type
Experimental
Arm Description
Patients with diagnosed Parkinson's disease
Arm Title
Control
Arm Type
Experimental
Arm Description
Healthy adults
Intervention Type
Radiation
Intervention Name(s)
PET imaging
Intervention Description
Serotonin, Dopamine and Amyloid PET imaging
Primary Outcome Measure Information:
Title
Regional brain beta amyloid levels and regional brain serotonin terminal density as measured by PET brain imaging.
Description
The PET imaging measures of regional brain beta amyloid levels and regional serotonin terminal density will be compared across participants to determine if there is a relationship between the regional density of serotonin terminals and the accumulation of beta amyloid.
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Persons who have been diagnosed with Parkinson disease age 45 years and older are eligible to participate in this study.
Healthy older individuals (ages 60-80) without neurologic problems are eligible to participate.
Exclusion Criteria:
Individuals using some drugs cannot participate. These include anti-depressant medications, buproprion, or St. John's Wort, as well as dopamine antagonist medications.
Women of childbearing age may not participate.
Individuals unable to have MRI scans because of a pacemaker or metal fragments may not participate.
Individuals with a history of stroke may not participate. People with any contraindication of PET imaging such as previous participation in research procedures involving ionizing radiation may not be eligible to participate in this study.
Facility Information:
Facility Name
University of Michigan Health System
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
12. IPD Sharing Statement
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Serotonin and Amyloidopathy
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