NCT06678100 Swallowing Impairments in Adults With and Without Alzheimer's Disease
| NCT ID | NCT06678100 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Vanderbilt University Medical Center |
| Condition | Alzheimer Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 240 participants |
| Start Date | 2025-04-21 |
| Primary Completion | 2027-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 240 participants in total. It began in 2025-04-21 with a primary completion date of 2027-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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/health care decision maker 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)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06678100 clinical trial?
This trial is open to participants of all sexes, aged 60 Years or older, studying Alzheimer Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06678100 currently recruiting?
Yes, NCT06678100 is actively recruiting participants. Contact the research team at cara.donohue@vumc.org for enrollment information.
Where is the NCT06678100 trial being conducted?
This trial is being conducted at Nashville, United States.
Who is sponsoring the NCT06678100 clinical trial?
NCT06678100 is sponsored by Vanderbilt University Medical Center. The trial plans to enroll 240 participants.
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