NCT00736671

Brief Summary

This research study will evaluate functions of memory, thinking, eye movements and 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. At the present time, the investigators have no clear information how these two chemicals in the brain of patients with Parkinson's disease are related to the risk of falling.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2006

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2006

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

August 15, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 18, 2008

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
Last Updated

March 4, 2016

Status Verified

March 1, 2016

Enrollment Period

3.8 years

First QC Date

August 15, 2008

Last Update Submit

March 2, 2016

Conditions

Study Arms (2)

Observational Parkinson's Disease

Observational study of subjects with Parkinson disease

Observational Normal Control aubjects

Observational study of normal control subjects

Eligibility Criteria

Age50 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with Parkinson's disease 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.

You may qualify if:

  • The racial, gender and ethnic characteristics of the proposed subjects population reflect the demographics of the patient population of the VA. However, extra efforts will be made to recruit women and minorities (see table 5).
  • Children will be excluded from the study.

You may not qualify if:

  • Inability to stand or walk independently (i.e., patients in Hoehn and Yahr stage IV and V).
  • Vertiginous disorder.
  • Orthostatic hypotension or unstable cardiovascular disease at risk of syncope (drop in systolic blood pressure of \> 20 mm Hg upon standing).
  • History of stroke with focal cortical lesions.
  • Cerebellar, myelopathic or significant radiculopathy syndrome.
  • Diminished light perception in both eyes (\< 20/40 corrected OU).
  • Intracranial surgery.
  • Subjects who have participated in other research protocols such that their cumulative radiation absorbed dose to whole body, gonads, bone marrow or lens of the eye would exceed 5 Rem, or dose to other body organs is more than 15 Rem in preceding 12 months.
  • Pregnancy (beta-HCG test within 48 hours of PET study) or breastfeeding.
  • Contra-indications to MRI.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan Functional Neuroimaging, Cognnitive and Mobility Laboratory

Ann Arbor, Michigan, 48106, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Nicolaas Bohnen

    VAAAHS

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 15, 2008

First Posted

August 18, 2008

Study Start

July 1, 2006

Primary Completion

April 1, 2010

Study Completion

August 1, 2010

Last Updated

March 4, 2016

Record last verified: 2016-03

Data Sharing

IPD Sharing
Will not share

Locations