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OpenTrials
Completed

NCT Number: NCT02895932

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.

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Key information

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan Health System

Ann Arbor, Michigan, 48109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PET Imaging

Radiation

Serotonin, Dopamine and Amyloid PET imaging

Primary outcomes

  1. Regional brain beta amyloid levels and regional brain serotonin terminal density as measured by PET brain imaging.

    Time frame: 2 years

    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.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Sep 12, 2016
Registry last updated
Sep 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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