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

NCT03299062 | Completed Results FDA Device

• 1 other identifier: 206829
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Alpha-synuclein Levels From Nasal Swabs

  Determine if nasal swabs can provide an adequate sample for evaluation using cytology and immunohistochemistry for alpha-synuclein, Amyloid-beta (A-beta) and Phospho-tau (p-tau) staining.

  Up to 4 weeks after swab is completed

Study Arms (3)

Parkinson's Disease with Voice Dysfunction Patients

ACTIVE COMPARATOR

• Twenty people with Parkinson's Disease requiring evaluation of voice dysfunction by an Ear, Nose, and Throat (ENT) doctor

Diagnostic Test: Cytology and Immunohistochemistry

Other Neurodegenerative Disorders with Voice Dysfunction

ACTIVE COMPARATOR

• Twenty people with other neurodegenerative disorders requiring evaluation of voice dysfunction by an ENT doctor.

Diagnostic Test: Cytology and Immunohistochemistry

Voice Dysfunction

PLACEBO COMPARATOR

Twenty people with voice tremor and/or presbylarynx, but no evidence of Parkinson's other neurodegenerative disease, requiring evaluation of voice dysfunction by an ENT doctor.

Diagnostic Test: Cytology and Immunohistochemistry

Interventions

Cytology and Immunohistochemistry DIAGNOSTIC_TEST

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

Other Neurodegenerative Disorders with Voice Dysfunction; Parkinson's Disease with Voice Dysfunction Patients; Voice Dysfunction

Eligibility Criteria

• Age: 19 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with idiopathic Parkinson's disease, progressive supranuclear palsy, Alzheimer's disease or Mild Cognitive Impairment based on consensus criteria, or suspicion of presbylarynx based on clinical evaluation.
• Require evaluation of voice dysfunction by an ENT doctor given symptoms of impaired voice volume or quality
• Age ≥ 18 years-old to ≤ 90-years old.
• Ability to understand and the willingness to sign a written informed consent.

You may not qualify if:

• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• Active nose bleeds, or abnormal anatomy of the nose that prevent safe nasal swabs, or active oropharyngeal disease that prevents laryngoscopy or voice assessments.

Sponsors & Collaborators

• University of Arkansas: lead

Study Sites (1)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

MeSH Terms

Conditions

Alzheimer Disease; Neurodegenerative Diseases

Interventions

Cytological Techniques; Immunohistochemistry

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Histocytochemistry; Histological Techniques; Immunologic Techniques

Limitations and Caveats

Due to lack of enrollment, and the COVID-19 pandemic, the analysis of biospecimens was not performed. None of the collected samples from this study were analyzed for the outcome measures in this record, and therefore there are no results to report beyond participant flow.

Results Point of Contact

• Title: Rohit Dhall, MD
• Organization: University of Arkansas for Medical Sciences

rdhall@uams.edu

6025033193

Study Officials

• Rohit Dhall, MD, MSPH

  University of Arkansas

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2017
• First Posted: October 2, 2017
• Study Start: November 14, 2017
• Primary Completion: December 21, 2021
• Study Completion: December 21, 2021
• Last Updated: November 25, 2022
• Results First Posted: November 25, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)