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Executive, Activities of Daily Living, and Cholinergic Functions in Parkinson's Disease

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ClinicalTrials.gov Identifier: NCT00737217
Recruitment Status : Completed
First Posted : August 18, 2008
Last Update Posted : June 26, 2013
Sponsor:
Collaborator:
Michael J. Fox Foundation for Parkinson's Research
Information provided by (Responsible Party):
Nicolaas Bohnen, MD, PhD, University of Michigan

Study Description
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Brief Summary:
This research study will evaluate functions of memory, thinking, behavior, and daily life activities and how these relate to the measurement of certain chemicals (acetylcholine and dopamine) in the brain using an imaging procedure called positron emission tomography (PET). You may know that in Alzheimer's dementia (dementia is a disease where persons become forgetful and confused), a reduction in the amount of acetylcholine, a "neurotransmitter" substance (a chemical messenger that nerve cells need to communicate with each other), may be responsible for some of the memory and behavioral changes. At the present time, the investigators have no clear information on the levels of acetylcholine in the brain of patients with Parkinson's disease who also have memory or behavioral changes.

Condition or disease Intervention/treatment
Parkinson's Disease Behavioral: Behavioral assessment/questionnaire

Study Design
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Study Type : Observational
Actual Enrollment : 74 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Executive, Activities of Daily Living, and Cholinergic Functions in Parkinson's Disease
Study Start Date : March 2006
Actual Primary Completion Date : April 2009
Actual Study Completion Date : April 2009

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Parkinson's disease Behavioral: Behavioral assessment/questionnaire
Complete behavioral assessment/questionnaire
Normal Controls Behavioral: Behavioral assessment/questionnaire
Complete behavioral assessment/questionnaire


Outcome Measures
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Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients with Parkinson's disease, either with or without memory or concentration difficulties, and normal control persons between the ages of 50-85 years are eligible to participate in this study. Participants should be willing and able to comply with study requirements. Normal control persons should not have a history of brain or mental disorders. Both males and females are eligible.
Criteria

Inclusion Criteria:

  • PDD: Patients who meet the UK Parkinson's Disease Society Brain Bank Research Center (UKPDSBRC) clinical diagnostic criteria for PD with dementia (MMSE 18-25; n=28; age 50-85 years; M/F) are eligible for the study. Hoehn and Yahr stages I-III.
  • PD. Patients with who meet the UKPDSBRC criteria for PD with a MMSE of >25 (n=28; age 50-85 years; M/F). Hoehn and Yahr stages I-III.
  • Normal control subjects (n=16) (age 50-85 years; M/F).
  • No current or past history of neurologic or psychiatric illness.

Exclusion Criteria:

  • Any subjects on cholinergic, anti-cholinergic drugs will be excluded from the study.
  • Current or past history of neurologic or psychiatric illness.
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT00737217


Locations
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United States, Michigan
University of Michigan Functional, Cognitive and Mobility Laboratory
Ann Arbor, Michigan, United States, 48106
Sponsors and Collaborators
University of Michigan
Michael J. Fox Foundation for Parkinson's Research
More Information
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Responsible Party: Nicolaas Bohnen, MD, PhD, Principal Investigator, University of Michigan
ClinicalTrials.gov Identifier: NCT00737217    
Other Study ID Numbers: 2005-0464
First Posted: August 18, 2008    Key Record Dates
Last Update Posted: June 26, 2013
Last Verified: June 2013
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases