Trial Outcomes & Findings for Smell, Voice and Nasal Swabs as Markers for Neuro-degenerative Disorders (NCT NCT03299062)
NCT ID: NCT03299062
Last Updated: 2022-11-25
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
9 participants
Primary outcome timeframe
Up to 4 weeks after swab is completed
Results posted on
2022-11-25
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
5
|
|
Overall Study
COMPLETED
|
4
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Smell, Voice and Nasal Swabs as Markers for Neuro-degenerative Disorders
Baseline characteristics by cohort
| Measure |
Parkinson's Disease With Voice Dysfunction Patients
n=4 Participants
• 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.
|
Other Neurodegenerative Disorders With Voice Dysfunction
n=5 Participants
• 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.
|
Voice Dysfunction
No subjects were enrolled in this arm.
|
Total
n=9 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
—
|
4 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
—
|
5 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Up to 4 weeks after swab is completedPopulation: 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.
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.
Outcome measures
Outcome data not reported
Adverse Events
Parkinson's Disease With Voice Dysfunction Patients
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Other Neurodegenerative Disorders With Voice Dysfunction
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Rohit Dhall, MD
University of Arkansas for Medical Sciences
Phone: 6025033193
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place