Serotonin and Amyloidopathy

NCT02895932 | Completed DMC

• 1 other identifier: HUM00094478
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson's Disease

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Case

EXPERIMENTAL

Patients with diagnosed Parkinson's disease

Radiation: PET imaging

Control

EXPERIMENTAL

Healthy adults

Radiation: PET imaging

Interventions

PET imaging RADIATION

Serotonin, Dopamine and Amyloid PET imaging

Case; Control

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan Health System

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 1, 2015
• First Posted: September 12, 2016
• Study Start: January 1, 2015
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2017
• Last Updated: September 5, 2018

Record last verified: 2018-08

Locations

US (1)