Decrease in Sense of Smell and Associated Cognitive Decline in Parkinson's Disease
Completed
Conditions studied: Parkinson's Disease
In brief
The overarching goal of this prospective cohort study is to test the hypotheses that greater severity of hyposmia is associated with increased risk of cognitive decline in PD and that worsening hyposmia parallels progressive cholinergic limbic denervation. To achieve the goals of this project, patients with PD without dementia or at-risk of dementia or with dementia will undergo longitudinal olfactory, cognitive and clinical testing for 2-4 years. AChE \[11C\]PMP or VAchT (vesicular acetylcholine transporter) \[F18\]-FEOBV PET will be performed both at study entry and at 2-years (± 6 months) follow-up. Brain MRI scans will also be performed at study entry and at 2-years (± 6 months) follow-up. Brain Beta-amyloid PET will be performed at study entry or at 2 years (± 6 months). Annual olfactory testing will be performed to better understand dynamic changes underlying the clinical and PET outcome measures.
Key facts
- Study ID
- NCT01572142
- Run by
- University of Michigan
- People needed
- 74
- Starts
- 2010-08-01
- Expected to finish
- 2016-07-01
- Last updated by the study team
- 2017-09-29
Who can join
Age: 50 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Diagnosed with Parkinson disease
- Hoehn \& Yahr stage 2 and higher, and/or duration of motor disease 5 years or longer
- 50 and older
You may not qualify if…
- other disorders which may resemble PD
- subjects with definite dementia
- subjects with unstable or severe medical disorders
- subjects receiving neuroleptic, anticholinergic, or cholinesterase inhibitor drugs
- subjects in whom MRI imaging is contraindicated
- subjects who have received ionizing radiation that would, together with the current project exposures, exceed exposure limits permissible to research volunteers
- pregnant
Where it is running
- Universtiy of Michigan Functional Neuroimaging, Cognitive and Mobility Laboratory — Ann Arbor, Michigan, United States
Full record on ClinicalTrials.gov
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