Imaging Biomarkers of Progression of Mobility Impairment in Parkinson Disease

NCT ID: NCT01106976

Last Updated: 2016-02-01

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

67 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-05-31

Study Completion Date

2015-03-31

Brief Summary

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The purpose of this research is to evaluate changes in cholinergic brain activity over time in subjects with Parkinson disease.

Detailed Description

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The project will apply positron emission tomography (PET) of acetylcholinesterase to study non-dopaminergic (i.e. cholinergic) brain changes over time in subjects with Parkinson disease. Acetylcholinesterase PET imaging was used to assess cholinergic changes over time in this study. Acetylcholinesterase PET imaging is a diagnostic test as the investigator does not assign specific interventions to the subjects of the study based on the acetylcholinesterase PET. Therefore, this is an observational study as defined as following: studies in human beings in which biomedical and/or health outcomes are assessed in pre-defined groups of individuals. Subjects in the study may receive diagnostic, therapeutic, or other interventions, but the investigator does not assign specific interventions to the subjects of the study.

Conditions

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Parkinson's Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1 Parkinson disease subjects

Subjects with Parkinson disease who previously participate in a motor and brain PET (brain positron emission tomography) imaging study who were invited for a longitudinal observational study.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Michigan

OTHER

Sponsor Role collaborator

VA Office of Research and Development

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nicolaas I Bohnen, MD PhD

Role: PRINCIPAL_INVESTIGATOR

VA Ann Arbor Healthcare System, Ann Arbor, MI

Locations

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VA Ann Arbor Healthcare System, Ann Arbor, MI

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

References

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Bohnen NI, Frey KA, Studenski S, Kotagal V, Koeppe RA, Scott PJ, Albin RL, Muller ML. Gait speed in Parkinson disease correlates with cholinergic degeneration. Neurology. 2013 Oct 29;81(18):1611-6. doi: 10.1212/WNL.0b013e3182a9f558. Epub 2013 Sep 27.

Reference Type RESULT
PMID: 24078735 (View on PubMed)

Muller ML, Albin RL, Kotagal V, Koeppe RA, Scott PJ, Frey KA, Bohnen NI. Thalamic cholinergic innervation and postural sensory integration function in Parkinson's disease. Brain. 2013 Nov;136(Pt 11):3282-9. doi: 10.1093/brain/awt247. Epub 2013 Sep 20.

Reference Type RESULT
PMID: 24056537 (View on PubMed)

Kotagal V, Albin RL, Muller ML, Koeppe RA, Frey KA, Bohnen NI. Diabetes is associated with postural instability and gait difficulty in Parkinson disease. Parkinsonism Relat Disord. 2013 May;19(5):522-6. doi: 10.1016/j.parkreldis.2013.01.016. Epub 2013 Feb 23.

Reference Type RESULT
PMID: 23462483 (View on PubMed)

Other Identifiers

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E7285-R

Identifier Type: -

Identifier Source: org_study_id

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