Amyloid Beta and Cognition in Parkinson Disease

NCT01754168 | Completed

• 1 other identifier: HUM00071121
• Study Type: observational
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators propose to study persons with Parkinson Disease (PD) with detailed clinical, cognitive and imaging at the time of study entry and repeat these assessments 2 years later. The study looks at how changes in activity of the neurotransmitter acetylcholine relates to changes in cognitive function and to see if there is presence or build up of amyloid protein.

Conditions

Parkinson Disease; Neurological Disorders

Keywords

Parkinson disease; Cognition

Outcome Measures

Primary Outcomes (3)

• Cholinergic innervation

  FEOBV PET scan

  Change from Baseline in cholinergic innervation at 2 years

• Cortical Amyloid Beta plaques

  PIB PET scan

  Change from Baseline in beta-amyloid deposition at 2 years

• Cognitive function

  Detailed neuropsychological test battery

  Change from Baseline in cognitive function at 2 years

Eligibility Criteria

• Age: 65 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

UM and VA Movement Disorders Clinic Primary Care Clinic Community

You may qualify if:

• PD diagnosis according to the UK PD Society of Brain Bank research Center criteria PD subjects at risk for dementia Age 50 and above, male or female Absence of dementia confirmed by clinical and detailed neurological assessment -

You may not qualify if:

• Subjects with contra-indications to MR imaging Evidence of large vessel stroke or mass on on MRI Use of cholinergic or neuroleptic drugs at baseline Evidence of atypical parkinsonism on neurological exam Subjects limited by participation in research procedures involving ionizing radiation Pregnancy(test within 48 hours of each PET session) or breastfeeding

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan Health System

Ann Arbor, Michigan, 48109, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Saliva samples with DNA

MeSH Terms

Conditions

Parkinson Disease; Nervous System Diseases

Condition Hierarchy (Ancestors)

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

Study Officials

• Nicolaas Bohnen, M.D., Phd

  University of Michigan

  PRINCIPAL INVESTIGATOR

• Roger Albin, M.D.

  University of Michigan

  PRINCIPAL INVESTIGATOR

• Martijn Muller, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Radiology and Neurology

Study Record Dates

• First Submitted: December 13, 2012
• First Posted: December 21, 2012
• Study Start: February 1, 2013
• Primary Completion: February 1, 2018
• Study Completion: February 1, 2018
• Last Updated: March 8, 2018

Record last verified: 2018-03

Locations

US (1)