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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nicolaas Bohnen, MD, PhD, University of Michigan
ClinicalTrials.gov Identifier:
NCT01572142
First received: April 3, 2012
Last updated: October 4, 2016
Last verified: October 2016

April 3, 2012
October 4, 2016
August 2010
July 2016   (final data collection date for primary outcome measure)
Olfactory testing [ Time Frame: Yearly follow up visits ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT01572142 on ClinicalTrials.gov Archive Site
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Decrease in Sense of Smell and Associated Cognitive Decline in Parkinson's Disease
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.
Observational
Observational Model: Case-Only
Time Perspective: Cross-Sectional
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Retention:   Samples With DNA
Description:
saliva
Non-Probability Sample
Movement Disorders Clinic, Hospital, Primary Care, Community
Parkinson's Disease
Not Provided
Parkinson disease group
Subjects with Parkinson disease
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
74
July 2016
July 2016   (final data collection date for primary outcome measure)

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
Both
50 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01572142
R01N5070856
No
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Nicolaas Bohnen, MD, PhD, University of Michigan
University of Michigan
Not Provided
Principal Investigator: Nicolaas Bohnen, M.D., Ph.D. University of Michigan
University of Michigan
October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP