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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Other Neurodegenerative Disorders with Voice Dysfunction | Active Comparator | • Twenty people with other neurodegenerative disorders requiring evaluation of voice dysfunction by an ENT doctor. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rohit Dhall, MD, MSPH | University of Arkansas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arkansas for Medical Sciences | Little Rock | Arkansas | 72205 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 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. |
| FG001 | Other Neurodegenerative Disorders With Voice Dysfunction | • Twenty people with other neurodegenerative disorders requiring evaluation of voice dysfunction by an ENT doctor. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Enrollment was stopped due to COVID-19 pandemic after 4 subjects with PD and 5 with other neurodegenerative disorders with voice dysfunction were enrolled.
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| ID | Title | Description |
|---|---|---|
| BG000 | Parkinson's Disease With Voice Dysfunction Patients | • Enrollment was stopped due to COVID-19 pandemic after 4 people with Parkinson's Disease requiring evaluation of voice dysfunction by an Ear, Nose, and Throat (ENT) doctor were enrolled. Cytology and Immunohistochemistry: Samples from 1 subject were processed for GFAP and S100 staining to confirm presence of olfactory neuronal tissue. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Due to early termination of subject enrollment, there were an insufficient number of samples to process for this analysis. As such, none of the samples were (or will be) analyzed for the outcome measures listed and therefore there are no results to report beyond participant flow. | Posted | Up to 4 weeks after swab is completed |
|
The study was done in a single session for each participant, typically taking 4 hours.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Parkinson's Disease With Voice Dysfunction Patients | Subjects with Parkinson's Disease with Voice Dysfunction Patients |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rohit Dhall, MD | University of Arkansas for Medical Sciences | 6025033193 | rdhall@uams.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 1, 2019 | Oct 31, 2022 | Prot_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 1, 2019 | Sep 27, 2022 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D019636 | Neurodegenerative Diseases |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D003584 | Cytological Techniques |
| D007150 | Immunohistochemistry |
| ID | Term |
|---|---|
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
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| BG001 | Other Neurodegenerative Disorders With Voice Dysfunction | • Enrollment was stopped due to COVID-19 pandemic after 5 people with other neurodegenerative disorders requiring evaluation of voice dysfunction by an ENT doctor. Cytology and Immunohistochemistry: No samples were processed for this group. |
| BG002 | Voice Dysfunction | No subjects were enrolled in this arm. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | Other Neurodegenerative Disorders With Voice Dysfunction | • Enrollment was stopped due to COVID-19 pandemic after 5 people with other neurodegenerative disorders requiring evaluation of voice dysfunction by an ENT doctor. Cytology and Immunohistochemistry: No samples were processed for this group. |
|
| 0 |
| 4 |
| 0 |
| 4 |
| 0 |
| 4 |
| EG001 | Other Neurodegenerative Disorders With Voice Dysfunction | Subjects with other Neurodegenerative Disorders with Voice Dysfunction | 0 | 5 | 0 | 5 | 0 | 5 |
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| D024801 |
| Tauopathies |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D006651 | Histocytochemistry |
| D006652 | Histological Techniques |
| D007158 | Immunologic Techniques |