| Registry | NCT03299062 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; non randomized, parallel, masking: none, diagnostic |
| Enrollment | 9 (Actual) |
| Sponsor | University of Arkansas (Other) |
| Conditions | Alzheimer Disease, Neurodegenerative Diseases |
| Interventions | Cytology and Immunohistochemistry (Diagnostic test) |
| Dates | start 2017-11-14, primary completion 2021-12-21, completion 2021-12-21, first posted 2017-10-02, last updated 2022-11-25 |
| Locations | 1 site in United States |
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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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Parkinson's Disease with Voice Dysfunction Patients | Active comparator | Diagnostic Test: Cytology and Immunohistochemistry | • Twenty people with Parkinson's Disease requiring evaluation of voice dysfunction by an Ear, Nose, and Throat (ENT) doctor |
| Other Neurodegenerative Disorders with Voice Dysfunction | Active comparator | Diagnostic Test: Cytology and Immunohistochemistry | • Twenty people with other neurodegenerative disorders requiring evaluation of voice dysfunction by an ENT doctor. |
| Voice Dysfunction | Placebo comparator | Diagnostic Test: Cytology and Immunohistochemistry | 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. |
Sex: All, ages: 19 Years to 89 Years
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.
| Milestone | Parkinson's Disease With Voice Dysfunction Patients | Other Neurodegenerative Disorders With Voice Dysfunction |
|---|---|---|
| Started | 4 | 5 |
| Completed | 4 | 5 |
| Not completed | 0 | 0 |
Time frame: The study was done in a single session for each participant, typically taking 4 hours.
| Arm | Deaths | Serious adverse events | Other adverse events |
|---|---|---|---|
| Parkinson's Disease With Voice Dysfunction Patients | 0/4 (0.0%) | 0/4 (0.0%) | 0/4 (0.0%) |
| Other Neurodegenerative Disorders With Voice Dysfunction | 0/5 (0.0%) | 0/5 (0.0%) | 0/5 (0.0%) |
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.
| Facility | City | Country | Status |
|---|---|---|---|
| University of Arkansas for Medical Sciences | Little Rock, Arkansas | United States |