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Hyposmia, Cholinergic Denervation and Incipient Cognitive Decline in PD
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.
Smell functions will be assessed using a test battery of odor identification, odor memory, and odor discrimination tests.
Age
50 - No limit years
Sex
ALL
Healthy Volunteers
No
Universtiy of Michigan Functional Neuroimaging, Cognitive and Mobility Laboratory
Ann Arbor, Michigan, United States
Start Date
August 1, 2010
Primary Completion Date
July 1, 2016
Completion Date
July 1, 2016
Last Updated
September 29, 2017
74
ACTUAL participants
Lead Sponsor
University of Michigan
NCT07310264
NCT02119611
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07216976