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OpenTrials
Completed

NCT Number: NCT01754168

Amyloid Beta and Cognition in Parkinson Disease

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.

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Key information

Age range

65 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Michigan Health System

Ann Arbor, Michigan, 48109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

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Treatment and study plan

Primary outcomes

  1. Cholinergic innervation

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

    FEOBV PET scan

  2. Cortical Amyloid Beta plaques

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

    PIB PET scan

  3. Cognitive function

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

    Detailed neuropsychological test battery

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
Dec 21, 2012
Registry last updated
Mar 8, 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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