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

This study has been completed.
Sponsor:
Collaborator:
Michael J. Fox Foundation for Parkinson's Research
Information provided by (Responsible Party):
Nicolaas Bohnen, MD, PhD, University of Michigan
ClinicalTrials.gov Identifier:
NCT00737217
First received: August 15, 2008
Last updated: June 24, 2013
Last verified: June 2013
  Purpose

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 Intervention
Parkinson's Disease
Behavioral: Behavioral assessment/questionnaire

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Executive, Activities of Daily Living, and Cholinergic Functions in Parkinson's Disease

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Enrollment: 74
Study Start Date: March 2006
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Parkinson's disease Behavioral: Behavioral assessment/questionnaire
Complete behavioral assessment/questionnaire
Normal Controls Behavioral: Behavioral assessment/questionnaire
Complete behavioral assessment/questionnaire

  Eligibility

Ages Eligible for Study:   50 Years to 85 Years
Genders Eligible for Study:   Both
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
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: NCT00737217

Locations
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

No publications provided

Responsible Party: Nicolaas Bohnen, MD, PhD, Principal Investigator, University of Michigan
ClinicalTrials.gov Identifier: NCT00737217     History of Changes
Other Study ID Numbers: 2005-0464
Study First Received: August 15, 2008
Last Updated: June 24, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 28, 2014