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

June 24, 2013 updated by: Nicolaas Bohnen, MD, PhD, University of Michigan
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

74

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48106
        • University of Michigan Functional, Cognitive and Mobility Laboratory

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Normal Controls
Behavioral: Behavioral assessment/questionnaire
Complete behavioral assessment/questionnaire
Parkinson's disease
Behavioral: Behavioral assessment/questionnaire
Complete behavioral assessment/questionnaire

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan

Collaborators

Michael J. Fox Foundation for Parkinson's Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2006

Primary Completion (Actual)

April 1, 2009

Study Completion (Actual)

April 1, 2009

Study Registration Dates

First Submitted

August 15, 2008

First Submitted That Met QC Criteria

August 15, 2008

First Posted (Estimate)

August 18, 2008

Study Record Updates

Last Update Posted (Estimate)

June 26, 2013

Last Update Submitted That Met QC Criteria

June 24, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2005-0464

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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