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OpenTrials
Completed

NCT Number: NCT01572142

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

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.

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Key information

Conditions

Parkinson's Disease Anosmia Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Neurologic Manifestations Olfaction Disorders Parkinson Disease Parkinsonian Disorders Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Synucleinopathies

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Universtiy of Michigan Functional Neuroimaging, Cognitive and Mobility Laboratory

Ann Arbor, Michigan, 48109, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Olfactory testing

    Time frame: Yearly follow up visits

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Official study title

Hyposmia, Cholinergic Denervation and Incipient Cognitive Decline in PD

Acronym: OLF

Important dates

Study start
2010
Primary completion
2016
Study completion
2016
First posted
Apr 6, 2012
Registry last updated
Sep 29, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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