Serotonin and Amyloidopathy

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.

Study Overview

• Status: Completed
• Conditions: Parkinson's Disease
• Intervention / Treatment: Radiation: PET imaging

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.

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Case; Patients with diagnosed Parkinson's disease	Radiation: PET imaging; Serotonin, Dopamine and Amyloid PET imaging
Experimental: Control; Healthy adults	Radiation: PET imaging; Serotonin, Dopamine and Amyloid PET imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2 years

Collaborators and Investigators

• Sponsor: University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2015
• Primary Completion (Actual): October 1, 2017
• Study Completion (Actual): October 1, 2017

Study Registration Dates

• First Submitted: December 1, 2015
• First Submitted That Met QC Criteria: September 6, 2016
• First Posted (Estimate): September 12, 2016

Study Record Updates

• Last Update Posted (Actual): September 5, 2018
• Last Update Submitted That Met QC Criteria: August 31, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: HUM00094478

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No