NCT06678100 · Vanderbilt University Medical Center
Swallowing Impairments in Adults With and Without Alzheimer's Disease
What this study is about
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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- for AD cohort:
- adult ≥60 years old
- diagnosis of AD by a neurologist (confirmed with imaging, spinal tap, behavioral testing)
- no prior history of other neurological diseases (aside from stroke which has resolved with no current symptoms)
- no prior history of respiratory diseases
- no prior history of head and neck surgery/head and neck cancer/radiation to head and neck region
- consuming some form of oral intake
- able to follow basic directions
- able/willing to provide consent/assent.
Exclusion criteria
- for AD Cohort:
- individual \<60 years old
- Diagnosis of another type of dementia
- History of neurological/respiratory diseases
- History of head and neck surgery/head and neck cancer/radiation to head and neck region
- not consuming any oral intake
- Unable to follow basic directions
- 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/health care decision maker provides consent. Inclusion criteria for care partners of individuals with AD will be:
- care partner of an individual with AD
- willing to complete questionnaires/participate in an interview. Exclusion Criteria for Caregivers of Individuals with AD:
- not the primary caregiver of an individual with AD
- unwilling to complete questionnaires/semi-structured interview Inclusion criteria for community-dwelling adults will be:
- adult ≥60 years old
- no prior history of neurological diseases (aside from stroke which has resolved with no current symptoms)
- 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:
- individual \<60 years old
- history of neurological disease
- history of respiratory disease
- history of head and neck surgery/head and neck cancer/radiation to head and neck region
- history of swallowing difficulties
- Score \<25th percentile based on sex/age/education/race on the Montreal Cognitive Assessment (MOCA)
Where
- Nashville, Tennessee
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 8, 2026 · Source of record for eligibility and locations