Clinical trial NCT01106976: Imaging Biomarkers of Progression of Mobility Impairment in Parkinson Disease
Official title: Imaging Biomarkers of Progression of Mobility Impairment in Parkinson Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson's Disease
Keywords: PET
acetylcholine
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: University of Michigan
First posted: 2010-04-20
Enrollment: 67
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Recruited in previous study

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

Detailed description: 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.

Eligibility 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

Primary outcomes:
measure: AChE PET Neuroimaging
timeFrame: 4 yr
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: VA Ann Arbor Healthcare System, Ann Arbor, MI
state: Michigan
Study officials:
affiliation: VA Ann Arbor Healthcare System, Ann Arbor, MI
name: Nicolaas I Bohnen, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.