Serotonin and Amyloidopathy

Parkinson's Disease Clinical Trial

Official title:

Serotonin and Amyloidopathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02895932
• Other study ID #: HUM00094478
• Status: Completed
• Phase: N/A
• Start date: January 2015
• Est. completion date: October 2017

Study information

• Verified date: August 2018
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: October 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Radiation:
• PET imaging
Serotonin, Dopamine and Amyloid PET imaging

Locations

Country	Name	City	State
United States	University of Michigan Health System	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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