An interventional study of Cytology and Immunohistochemistry in Alzheimer Disease and Neurodegenerative Diseases, sponsored by University of Arkansas. Completed at 1 site in United States. Open to participants aged 19 Years to 89 Years. Per ClinicalTrials.gov, last updated 2022-11-25.
Sponsored by University of Arkansas · Not applicable, Interventional, and Diagnostic
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.
Exclusion Criteria:
• Twenty people with Parkinson's Disease requiring evaluation of voice dysfunction by an Ear, Nose, and Throat (ENT) doctor
Diagnostic Test: Cytology and Immunohistochemistry
• Twenty people with other neurodegenerative disorders requiring evaluation of voice dysfunction by an ENT doctor.
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.
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
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.
Time frame: Up to 4 weeks after swab is completed
| Milestone | Parkinson's Disease With Voice Dysfunction Patients | Other Neurodegenerative Disorders With Voice Dysfunction |
|---|---|---|
| Started | 4 | 5 |
| Completed | 4 | 5 |
| Not completed | 0 | 0 |
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.
No measurements were reported for this outcome.
Collected over The study was done in a single session for each participant, typically taking 4 hours.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Parkinson's Disease With Voice Dysfunction Patients | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) |
| Other Neurodegenerative Disorders With Voice Dysfunction | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) |
Enrollment was stopped due to COVID-19 pandemic after 4 subjects with PD and 5 with other neurodegenerative disorders with voice dysfunction were enrolled.
| Age, Categorical(Participants) | Parkinson's Disease With Voice Dysfunction Patients | Other Neurodegenerative Disorders With Voice Dysfunction | Voice Dysfunction | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 0 | 3 | 0 | 3 |
| >=65 years | 4 | 2 | 0 | 6 |
| Sex: Female, Male(Participants) | Parkinson's Disease With Voice Dysfunction Patients | Other Neurodegenerative Disorders With Voice Dysfunction | Voice Dysfunction | Total |
|---|---|---|---|---|
| Female | 2 | 2 | — | 4 |
| Male | 2 | 3 | — | 5 |
| Race (NIH/OMB)(Participants) | Parkinson's Disease With Voice Dysfunction Patients | Other Neurodegenerative Disorders With Voice Dysfunction | Voice Dysfunction | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 | 0 |
| White | 4 | 5 | 0 | 9 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
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Plan to share: No
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University of Arkansas