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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Nicolaas Bohnen, MD, PhD, University of Michigan
ClinicalTrials.gov Identifier:
NCT01572142
First received: April 3, 2012
Last updated: May 19, 2014
Last verified: May 2014

April 3, 2012
May 19, 2014
August 2010
August 2015   (final data collection date for primary outcome measure)
Olfactory testing [ Time Frame: Yearly follow up visits ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT01572142 on ClinicalTrials.gov Archive Site
Not Provided
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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
Not Provided
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.
 
Active, not recruiting
75
August 2015
August 2015   (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
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01572142
R01N5070856
No
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
May 2014

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