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Amyloid Beta and Cognition in Parkinson Disease

Sponsor
University of Michigan (Other)
Overall Status
Completed
CT.gov ID
NCT01754168
Collaborator
(none)
44
Enrollment
1
Location
60
Duration (Months)
0.7
Patients Per Site Per Month

Study Details

Study Description

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 Intervention/Treatment Phase

    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.

    Study Design

    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 :
    Feb 1, 2013
    Actual Primary Completion Date :
    Feb 1, 2018
    Actual Study Completion Date :
    Feb 1, 2018

    Outcome Measures

    Primary Outcome Measures

    1. Cholinergic innervation [Change from Baseline in cholinergic innervation at 2 years]

      FEOBV PET scan

    2. Cortical Amyloid Beta plaques [Change from Baseline in beta-amyloid deposition at 2 years]

      PIB PET scan

    3. Cognitive function [Change from Baseline in cognitive function at 2 years]

      Detailed neuropsychological test battery

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    65 Years to 99 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    -

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Michigan Health System Ann Arbor Michigan United States 48109

    Sponsors and Collaborators

    • University of Michigan

    Investigators

    • 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Nicolaas Bohnen, MD, PhD, Professor of Radiology and Neurology, University of Michigan
    ClinicalTrials.gov Identifier:
    NCT01754168
    Other Study ID Numbers:
    • HUM00071121
    First Posted:
    Dec 21, 2012
    Last Update Posted:
    Mar 8, 2018
    Last Verified:
    Mar 1, 2018
    Keywords provided by Nicolaas Bohnen, MD, PhD, Professor of Radiology and Neurology, University of Michigan
    Parkinson disease
    Cognition
    Additional relevant MeSH terms:
    Parkinson Disease
    Nervous System Diseases

    Study Results

    No Results Posted as of Mar 8, 2018