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

NCT01572142 | Completed

• 1 other identifier: R01N5070856
• Study Type: observational
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Parkinson's Disease

Keywords

Parkinson disease; smell; cognitive

Outcome Measures

Primary Outcomes (1)

• Olfactory testing

  Yearly follow up visits

Study Arms (1)

Parkinson disease group

Subjects with Parkinson disease

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Movement Disorders Clinic, Hospital, Primary Care, Community

You may qualify if:

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

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

Universtiy of Michigan Functional Neuroimaging, Cognitive and Mobility Laboratory

Ann Arbor, Michigan, 48109, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

saliva

MeSH Terms

Conditions

Parkinson Disease; Anosmia

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Olfaction Disorders; Sensation Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Nicolaas Bohnen, M.D., Ph.D.

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 3, 2012
• First Posted: April 6, 2012
• Study Start: August 1, 2010
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: September 29, 2017

Record last verified: 2017-09

Locations

US (1)