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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01572142
Recruitment Status : Completed
First Posted : April 6, 2012
Last Update Posted : September 29, 2017
Information provided by (Responsible Party):
Nicolaas Bohnen, MD, PhD, University of Michigan

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.

Condition or disease
Parkinson's Disease

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

Study Type : Observational
Actual Enrollment : 74 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Hyposmia, Cholinergic Denervation and Incipient Cognitive Decline in PD
Study Start Date : August 2010
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

Parkinson disease group
Subjects with Parkinson disease

Primary Outcome Measures :
  1. Olfactory testing [ Time Frame: Yearly follow up visits ]

Biospecimen Retention:   Samples With DNA

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Movement Disorders Clinic, Hospital, Primary Care, Community

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01572142

United States, Michigan
Universtiy of Michigan Functional Neuroimaging, Cognitive and Mobility Laboratory
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Principal Investigator: Nicolaas Bohnen, M.D., Ph.D. University of Michigan

Additional Information:
Responsible Party: Nicolaas Bohnen, MD, PhD, Professor, University of Michigan Identifier: NCT01572142     History of Changes
Other Study ID Numbers: R01N5070856
First Posted: April 6, 2012    Key Record Dates
Last Update Posted: September 29, 2017
Last Verified: September 2017

Keywords provided by Nicolaas Bohnen, MD, PhD, University of Michigan:
Parkinson disease

Additional relevant MeSH terms:
Parkinson Disease
Cognitive Dysfunction
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Cognition Disorders
Neurocognitive Disorders
Mental Disorders