Imaging Biomarkers of Progression of Mobility Impairment in Parkinson's Disease (PD)
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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 |
- 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) |
| Groups/Cohorts |
|---|
| Group 1 |
Eligibility| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Recruited in previous study
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| United States, Michigan | |
| VA Ann Arbor Healthcare System | |
| Ann Arbor, Michigan, United States, 48113 | |
| Principal Investigator: | Nicolaas I Bohnen, MD PhD | VA Ann Arbor Healthcare System |
More Information
Additional Information:
No publications provided
| 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: | June 13, 2013 |
| 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 June 13, 2013