← Back to searchRecruitingRecruiting
Swallowing Impairments in Adults With and Without Alzheimer's Disease
NCT06678100 · Vanderbilt University Medical Center
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
Prevalence and Care Partner Burden of Individuals With Alzheimer's Disease
About this study
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.
Eligibility criteria
Inclusion criteria for AD cohort:
1. adult ≥60 years old
2. diagnosis of AD by a neurologist (confirmed with imaging, spinal tap, behavioral testing)
3. no prior history of other neurological diseases (aside from stroke which has resolved with no current symptoms)
4. no prior history of respiratory diseases
5. no prior history of head and neck surgery/head and neck cancer/radiation to head and neck region
6. consuming some form of oral intake
7. able to follow basic directions
8. able/willing to provide consent/assent.
Exclusion Criteria for AD Cohort:
1. individual \<60 years old
2. Diagnosis of another type of dementia
3. History of neurological/respiratory diseases
4. History of head and neck surgery/head and neck cancer/radiation to head and neck region
5. not consuming any oral intake
6. Unable to follow basic directions
7. Unable to provide consent based on the University of California, San Diego Brief Assessment of Capacity to Consent (UBACC), score \<15 OR provide assent and a legal guardian provides consent.
Inclusion criteria for care partners of individuals with AD will be:
1. care partner of an individual with AD
2. willing to complete questionnaires/participate in an interview.
Exclusion Criteria for Caregivers of Individuals with AD:
1. not the primary caregiver of an individual with AD
2. unwilling to complete questionnaires/semi-structured interview
Inclusion criteria for community-dwelling adults will be:
1. adult ≥60 years old
2. no prior history of neurological diseases (aside from stroke which has resolved with no current symptoms)
3. no prior history of respiratory diseases
3\) no prior history of head and neck surgery/head and neck cancer/radiation to head and neck region 4) no prior history of swallowing difficulties based on participant report. 5) Score ≥25th percentile based on sex/age/education/race on the Montreal Cognitive Assessment (MOCA)
Exclusion Criteria for Healthy Cohort:
1. individual \<60 years old
2. history of neurological disease
3. history of respiratory disease
4. history of head and neck surgery/head and neck cancer/radiation to head and neck region
5. history of swallowing difficulties
6. Score \<25th percentile based on sex/age/education/race on the Montreal Cognitive Assessment (MOCA)
Study design
Enrollment target: 240 participants
Age groups: adult, older_adult
Timeline
Starts: 2025-04-21
Estimated completion: 2028-02
Last updated: 2025-06-19
Primary outcomes
- • Swallowing safety (During baseline visit at time of enrollment.)
Sponsor
Vanderbilt University Medical Center · other
Contacts & investigators
ContactCara Donohue, PhD CCC-SLP · contact · cara.donohue@vumc.org · 615-852-5085
All locations (1)
Vanderbilt University Medical CenterRecruiting
Nashville, Tennessee, United States