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

Parkinson's Disease Clinical Trial

— OLF  

Official title:

Hyposmia, Cholinergic Denervation and Incipient Cognitive Decline in PD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01572142
• Other study ID #: R01N5070856
• Status: Completed
• Phase: N/A
• First received: April 3, 2012
• Last updated: September 27, 2017
• Start date: August 2010
• Est. completion date: July 2016

Study information

• Verified date: September 2017
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Locations

Country	Name	City	State
United States	Universtiy of Michigan Functional Neuroimaging, Cognitive and Mobility Laboratory	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Olfactory testing		Yearly follow up visits

External Links

•   clinical test center