NCT03299062

Smell, Voice and Nasal Swabs as Markers for Neuro-degenerative Disorders

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: University of Arkansas · Academic / Other
• Sex: All
• Age: 19 Years – 89 Years
• Healthy volunteers: Not accepted

Summary

Degenerative dementias including Alzheimer's Disease (AD), Parkinson's Disease with Dementia (PDD), Dementia with Lewy Bodies (DLB), Frontotemporal Dementias (FTLD), Corticobasal Degeneration (CBD) and Progressive Supranuclear Palsy (PSP) constitute a significant, and growing burden with an estimated cost to the US healthcare system for 2016 of $236 Billion (1). Definitive diagnosis of these dementias is based on pathological criterion upon autopsy, which presents a significant challenge to establish diagnosis in living patients. Although clinical diagnostic criteria have been developed for several of these disorders, including for Alzheimer's Disease (AD) by the National Institute of Neurological and Communicative Disorders and Stroke and Alzheimers Disease and Related Disorders Association (NINCDS-ADRDA) , Parkinson's Disease (PD) by the United Kingdom Parkinson Disease Brain Bank Diagnostic Criteria (UKPDBB) diagnostic criteria for Parkinson Disease(4) and others, the currently available tests, including the use of imaging markers and Cerebrospinal Fluid (CSF) biological markers do not provide a definite diagnosis since this requires the observation of characteristic neuropathological changes in specific regions of the brain.

Conditions

• Alzheimer Disease
• Neurodegenerative Diseases

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Cytology and Immunohistochemistry	Determine if nasal swabs can provide an adequate sample for evaluation using cytology and immunohistochemistry for alpha-synuclein, A-beta and p-tau staining.

Timeline

• Start date: 2017-11-14
• Primary completion: 2021-12-21
• Completion: 2021-12-21
• First posted: 2017-10-02
• Last updated: 2022-11-25
• Results posted: 2022-11-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study