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

Hyposmia, Cholinergic Denervation and Incipient Cognitive Decline in PD

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01572142

Acronym

OLF

Enrollment

Registered

2012-04-06

Start date

2010-08-31

Completion date

2016-07-31

Last updated

2017-09-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson's Disease

Keywords

Parkinson disease, smell, cognitive

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.

Detailed description

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

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Olfactory testing	Yearly follow up visits

Countries

United States

Outcome results