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Clinical Trials/NCT01754168
NCT01754168
Completed
Not Applicable

The Role of Amyloid Beta in the Progression of Cognitive Impairment in PD: A Prospective Cohort Study

University of Michigan1 site in 1 country44 target enrollmentFebruary 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Parkinson Disease
Sponsor
University of Michigan
Enrollment
44
Locations
1
Primary Endpoint
Cortical Amyloid Beta plaques
Status
Completed
Last Updated
8 years ago

Overview

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.

Detailed Description

Participants with PD will be studied at initial visit assessing clinical, cognitive, and brain imaging. A one year and, if applicable, three year cognitive assessment will be done, and the entire/complete assessment (same as initial visit) will be repeated again at two years. There will be a maximum of three follow up visits. The imaging test battery will consist of amyloid and acetylcholine brain PET and MRI scans. The use of acetylcholine PET imaging will demonstrate how changes in activity of this neurotransmitter relate to changes in cognitive functions, such as memory and mental concentration. A key question will be whether persons with PD who not only are losing acetylcholine brain cells but also have the buildup of the Alzheimer amyloid protein have a more rapid progression with more severe cognitive decline and behavioral changes compared to persons who do not have the amyloid protein.

Registry
clinicaltrials.gov
Start Date
February 2013
End Date
February 2018
Last Updated
8 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Nicolaas Bohnen, MD, PhD

Professor of Radiology and Neurology

University of Michigan

Eligibility Criteria

Inclusion Criteria

  • 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 -

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

Cortical Amyloid Beta plaques

Time Frame: Change from Baseline in beta-amyloid deposition at 2 years

PIB PET scan

Cognitive function

Time Frame: Change from Baseline in cognitive function at 2 years

Detailed neuropsychological test battery

Cholinergic innervation

Time Frame: Change from Baseline in cholinergic innervation at 2 years

FEOBV PET scan

Study Sites (1)

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