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
  Purpose

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
Parkinson's Disease

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Hyposmia, Cholinergic Denervation and Incipient Cognitive Decline in PD

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • Olfactory testing [ Time Frame: Yearly follow up visits ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

saliva


Estimated Enrollment: 75
Study Start Date: August 2010
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Parkinson disease group
Subjects with Parkinson disease

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Movement Disorders Clinic, Hospital, Primary Care, Community

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01572142

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

Additional Information:
No publications provided

Responsible Party: Nicolaas Bohnen, MD, PhD, Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT01572142     History of Changes
Other Study ID Numbers: R01N5070856
Study First Received: April 3, 2012
Last Updated: May 19, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Michigan:
Parkinson disease
smell
cognitive

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on October 16, 2014