Smell, Voice and Nasal Swabs as Markers for Neuro-degenerative Disorders
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ClinicalTrials.gov Identifier: NCT03299062 |
Recruitment Status :
Completed
First Posted : October 2, 2017
Results First Posted : November 25, 2022
Last Update Posted : November 25, 2022
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Condition or disease | Intervention/treatment | Phase |
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Alzheimer Disease Neurodegenerative Diseases | Diagnostic Test: Cytology and Immunohistochemistry | Not Applicable |
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 |

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
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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.
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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. |
- 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.

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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 |
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.

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
United States, Arkansas | |
University of Arkansas for Medical Sciences | |
Little Rock, Arkansas, United States, 72205 |
Principal Investigator: | Rohit Dhall, MD, MSPH | University of Arkansas |
Documents provided by University of Arkansas:
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | Yes |
Alzheimer Disease Neurodegenerative Diseases Dementia Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Tauopathies Neurocognitive Disorders Mental Disorders |