Alzheimer Disease, Neurodegenerative Diseases
Conditions
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.
Interventions
DIAGNOSTIC_TESTCytology 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.
Sponsors
University of Arkansas
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 89 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Alpha-synuclein Levels From Nasal Swabs | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 4 |
| 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. | 5 |
| Voice Dysfunction No subjects were enrolled in this arm. | 0 |
| Total | 9 |
Baseline characteristics
| Characteristic | Total | Parkinson's Disease With Voice Dysfunction Patients | Other Neurodegenerative Disorders With Voice Dysfunction | Voice Dysfunction |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 6 Participants | 4 Participants | 2 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants | 0 Participants | 3 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 9 Participants | 4 Participants | 5 Participants | 0 Participants |
| Sex: Female, Male Female | 4 Participants | 2 Participants | 2 Participants | — |
| Sex: Female, Male Male | 5 Participants | 2 Participants | 3 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 4 | 0 / 5 |
| other Total, other adverse events | 0 / 4 | 0 / 5 |
| serious Total, serious adverse events | 0 / 4 | 0 / 5 |
Outcome results
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.
Time frame: Up to 4 weeks after swab is completed
Population: 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.