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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03299062
Recruitment Status : Completed
First Posted : October 2, 2017
Results First Posted : November 25, 2022
Last Update Posted : November 25, 2022
Sponsor:
Information provided by (Responsible Party):
University of Arkansas

Study Description
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Alzheimer Disease Neurodegenerative Diseases Diagnostic Test: Cytology and Immunohistochemistry Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Smell, Voice and Nasal Swabs as Markers for Neuro-degenerative Disorders
Actual Study Start Date : November 14, 2017
Actual Primary Completion Date : December 21, 2021
Actual Study Completion Date : December 21, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Parkinson's Disease with Voice Dysfunction Patients
• Twenty people with Parkinson's Disease requiring evaluation of voice dysfunction by an Ear, Nose, and Throat (ENT) doctor
 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.
Active Comparator: Other Neurodegenerative Disorders with Voice Dysfunction
• Twenty people with other neurodegenerative disorders requiring evaluation of voice dysfunction by an ENT doctor.
 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.
Placebo Comparator: Voice Dysfunction
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
Determine if nasal swabs can provide an adequate sample for evaluation using cytology and immunohistochemistry for alpha-synuclein, A-beta and p-tau staining.


Outcome Measures
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Primary Outcome Measures :
  1. Alpha-synuclein Levels From Nasal Swabs [ Time Frame: Up to 4 weeks after swab is completed ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   19 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03299062


Locations
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United States, Arkansas
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
Sponsors and Collaborators
University of Arkansas
Investigators
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Principal Investigator: Rohit Dhall, MD, MSPH University of Arkansas
  Study Documents (Full-Text)

Documents provided by University of Arkansas:
Study Protocol  [PDF] January 1, 2019
Informed Consent Form  [PDF] January 1, 2019
No Statistical Analysis Plan (SAP) exists for this study.

More Information
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Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT03299062    
Other Study ID Numbers: 206829
First Posted: October 2, 2017    Key Record Dates
Results First Posted: November 25, 2022
Last Update Posted: November 25, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Alzheimer Disease
Neurodegenerative Diseases
Dementia
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Tauopathies
Neurocognitive Disorders
Mental Disorders