Amyloid Beta and Cognition in Parkinson Disease

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by University of Michigan
Sponsor:
Information provided by (Responsible Party):
Nicolaas Bohnen, MD, PhD, University of Michigan
ClinicalTrials.gov Identifier:
NCT01754168
First received: December 13, 2012
Last updated: May 20, 2014
Last verified: May 2014
  Purpose

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
Parkinson Disease
Neurological Disorders

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • Cholinergic innervation [ Time Frame: Change from Baseline in cholinergic innervation at 2 years ] [ Designated as safety issue: No ]
    FEOBV PET scan

  • Cortical Amyloid Beta plaques [ Time Frame: Change from Baseline in beta-amyloid deposition at 2 years ] [ Designated as safety issue: No ]
    PIB PET scan

  • Cognitive function [ Time Frame: Change from Baseline in cognitive function at 2 years ] [ Designated as safety issue: No ]
    Detailed neuropsychological test battery


Biospecimen Retention:   Samples With DNA

Saliva samples with DNA


Estimated Enrollment: 50
Study Start Date: February 2013
Estimated Study Completion Date: February 2018
Estimated Primary Completion Date: February 2018 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

UM and VA Movement Disorders Clinic

Primary Care Clinic

Community

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

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  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01754168

Contacts
Contact: Christine Minderovic 734-998-8400 or 877-998-1098 cmindero@umich.edu
Contact: Cyrus Sarosh 74-998-8400 or 877-998-1098 csarosh@med.umich.edu

Locations
United States, Michigan
University of Michigan Health System Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Christine Minderovic, B.S.    1-734-998-8400 or 877-998-1098    cmindero@umich.edu   
Contact: Cyrus Sarosh, B.S.    1-734-998-8400 or 877-998-1098    csarosh@umich.edu   
Principal Investigator: Nicolaaas Bohnen, M.D., PhD         
Principal Investigator: Roger Albin, MD         
Principal Investigator: Martijn Muller, PhD         
Sub-Investigator: Vikas Kotagal, M.D.         
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
  More Information

No publications provided

Responsible Party: Nicolaas Bohnen, MD, PhD, Professor of Radiology and Neurology, University of Michigan
ClinicalTrials.gov Identifier: NCT01754168     History of Changes
Other Study ID Numbers: HUM00071121
Study First Received: December 13, 2012
Last Updated: May 20, 2014
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by University of Michigan:
Parkinson disease
Cognition

Additional relevant MeSH terms:
Nervous System Diseases
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on July 20, 2014