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Amyloid Beta and Cognition in Parkinson Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01754168
Recruitment Status : Completed
First Posted : December 21, 2012
Last Update Posted : March 8, 2018
Information provided by (Responsible Party):
Nicolaas Bohnen, MD, PhD, University of Michigan

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.

Condition or disease
Parkinson Disease Neurological Disorders

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.

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Study Type : Observational
Actual Enrollment : 44 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Role of Amyloid Beta in the Progression of Cognitive Impairment in PD: A Prospective Cohort Study
Study Start Date : February 2013
Actual Primary Completion Date : February 2018
Actual Study Completion Date : February 2018

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  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

Biospecimen Retention:   Samples With DNA
Saliva samples with DNA

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   65 Years to 99 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

UM and VA Movement Disorders Clinic

Primary Care Clinic



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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01754168

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United States, Michigan
University of Michigan Health System
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
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Principal Investigator: 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
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Responsible Party: Nicolaas Bohnen, MD, PhD, Professor of Radiology and Neurology, University of Michigan Identifier: NCT01754168    
Other Study ID Numbers: HUM00071121
First Posted: December 21, 2012    Key Record Dates
Last Update Posted: March 8, 2018
Last Verified: March 2018
Keywords provided by Nicolaas Bohnen, MD, PhD, University of Michigan:
Parkinson disease
Additional relevant MeSH terms:
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Parkinson Disease
Nervous System Diseases
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases