Imaging Biomarkers of Progression of Mobility Impairment in Parkinson's Disease (PD)

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
University of Michigan
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01106976
First received: April 14, 2010
Last updated: April 15, 2014
Last verified: April 2014
  Purpose

The purpose of this research is to evaluate possible reasons why people with Parkinson's disease tend to fall more often. Parkinson's disease is a disease where persons have slowness in movements and walking as well as symptoms of shaking. You are being asked to participate in this study because you previously participated as a person with Parkinson's or as a normal comparison subject in a similar imaging study about 3-4 years ago. The previous research study evaluated functions of memory, thinking, walking 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 the brain chemical dopamine, a "neurotransmitter" substance (a chemical messenger that nerve cells need to communicate with each other), is important for the brain to control movements and that the brain chemical acetylcholine may have functions related to mental concentration and attention. You are now being asked for a new study as a follow-up about 3 years after the previous study. The main purpose of the follow-up study is to determine which of the two brain chemicals (dopamine, acetylcholine) or changes seen on brain MR called "small vessel disease" (which is commonly seen with aging) are related to development of balance problems. The study activities are very similar as the previous study you participated in.


Condition
Parkinson's Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Imaging Biomarkers of Progression of Mobility Impairment in PD

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • PET and MRI neuroimaging [ Time Frame: 7 months ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Saliva


Estimated Enrollment: 100
Study Start Date: May 2010
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Recruited in previous study

Criteria

Inclusion Criteria:

  • Patients who meet the UK Parkinson's Disease Society Brain Bank Research Center clinical diagnostic criteria for PD.
  • Hoehn and Yahr stages 1-2.5 at initial recruitment in baseline study.
  • Absence of dementia confirmed by neuropsychological testing at initial recruitment in baseline study.

Exclusion Criteria:

  • contra-indication for magnetic resonance study
  • Pregnancy or breastfeeding
  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: NCT01106976

Locations
United States, Michigan
VA Ann Arbor Healthcare System
Ann Arbor, Michigan, United States, 48113
Sponsors and Collaborators
University of Michigan
Investigators
Principal Investigator: Nicolaas I Bohnen, MD PhD VA Ann Arbor Healthcare System
  More Information

Additional Information:
Publications:
Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01106976     History of Changes
Other Study ID Numbers: E7285-R
Study First Received: April 14, 2010
Last Updated: April 15, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
accidental falls
PET
cognitive
dopamine
acetylcholine
MRI

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

ClinicalTrials.gov processed this record on July 20, 2014