Decrease in Sense of Smell and Associated Cognitive Decline in Parkinson's Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

74 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-08-31

Study Completion Date

2016-07-31

Brief Summary

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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.

Detailed Description

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Smell functions will be assessed using a test battery of odor identification, odor memory, and odor discrimination tests.

Conditions

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Parkinson's Disease

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Parkinson disease group

Subjects with Parkinson disease

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Diagnosed with Parkinson disease
* Hoehn \& Yahr stage 2 and higher, and/or duration of motor disease 5 years or longer
* 50 and older

Exclusion Criteria

* 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

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Nicolaas Bohnen, MD, PhD

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nicolaas Bohnen, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

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Universtiy of Michigan Functional Neuroimaging, Cognitive and Mobility Laboratory

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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R01N5070856

Identifier Type: -

Identifier Source: org_study_id