Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
Location status: Recruiting
NCT Number: NCT06678100
This research study is investigating whether people with Alzheimer's disease (AD) experience more changes to swallowing than their healthy age-matched peers. The prevalence of swallowing impairments in moderate-severe AD is high (85-93%), yet little is known about how swallow function evolves throughout the disease course in people with AD. The overall objective of this study is to evaluate swallowing function in adults with and without Alzheimer's disease. The investigator will also be involving the primary caregivers of individuals with Alzheimer's that are enrolled in the study to better understand the impact of swallowing impairments on the primary caregivers of those with Alzheimer's Disease.
Healthy adults and individuals with Alzheimer's disease will:
* undergo tests of cough and swallow function * undergo tests of grip and tongue strength * complete questionnaires
Caregivers of individuals with Alzheimer's disease will also complete questionnaires.
Interested in participating?
Request Info60 year and older
All sexes
Observational
Nashville, Tennessee, 37232, United States
Location status: Recruiting
This study will involve one in-person research visit that will last approximately 1-1.5 hours and will consist of a screening, cough testing, swallow function testing, assessments of hand grip and tongue strength, and completion of questionnaires. Caregivers of those with Alzheimer's disease will also complete questionnaires.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
for AD cohort:
Exclusion criteria
for AD Cohort:
Inclusion criteria
for care partners of individuals with AD will be:
Exclusion criteria
for Caregivers of Individuals with AD:
Inclusion criteria
for community-dwelling adults will be:
Exclusion criteria
for Healthy Cohort:
Time frame: During baseline visit at time of enrollment.
The penetration aspiration scale is a validated 8-point ordinal rating scale that measures the depth of airway invasion and the patient's response during swallowing. Scores range from 1 to 8 with a score of 1 indicating a safe swallow (best score) and 8 indicating silent aspiration (worst score).
Time frame: During baseline visit at time of enrollment
A measure of cough strength
Time frame: During baseline visit at time of enrollment.
Grip strength be used to quantify clinical frailty using a digital hand dynamometer.
Time frame: During baseline visit at time of enrollment.
Tongue strength will be assessed using the Iowa Oral Pressure Instrument (IOPI).
Time frame: During baseline visit at time of enrollment.
Scores on the SERF range 0-48 with higher scores indicating greater impairment.
Time frame: During baseline visit at time of enrollment.
Scores on the SWAL-QOL range from 0-100 with lower scores indicating greater impairment.
Time frame: During baseline visit at time of enrollment.
The EAT-10 contains 10 questions (score range: 0-40), higher scores indicate greater impairment.
Time frame: During baseline visit at time of enrollment.
Scores on the CARES range from 0-26 with higher scores indicating greater caregiver burden.
Time frame: During baseline visit at time of enrollment.
Scores range from 0-16 with higher scores indicating greater caregiver burden
Time frame: During baseline visit at time of enrollment.
Participants will be given a cup of three ounces of water and instructed to drink the water continuously. Fail criteria includes interrupted drinking and/or coughing/throat clearing during or immediately following the drinking task.
Time frame: During baseline visit at time of enrollment.
Participants will undergo reflex cough testing.
Time frame: During baseline visit at time of enrollment.
Oral frailty will be assessed as present/absent using the Screening for Oral Frailty Tool.
Contact information is provided by the study sponsor or research team.
Vanderbilt University Medical Center
Other
Prevalence and Care Partner Burden of Individuals With Alzheimer's Disease
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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