Swallowing Impairments in Adults With and Without Alzheimer's Disease
Launched by VANDERBILT UNIVERSITY MEDICAL CENTER · Nov 5, 2024
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying how swallowing abilities change in adults with Alzheimer's disease (AD) compared to healthy older adults. Researchers want to learn more about swallowing difficulties, known as dysphagia, which are common in people with moderate to severe AD. They will also explore how these swallowing issues affect the caregivers of individuals with Alzheimer's. The study will involve participants undergoing tests to assess their swallowing and coughing abilities, strength in their hands and tongues, and completing some questionnaires. Caregivers will also be asked to provide their insights through questionnaires.
To participate, you need to be at least 60 years old. For those with Alzheimer's, you must have a diagnosis confirmed by a doctor and be able to follow basic directions. Healthy adults must not have any history of neurological or swallowing problems. If you are a caregiver for someone with Alzheimer's, you can also take part by agreeing to answer questions. This study is currently recruiting participants, and it offers a chance to contribute valuable information that could help improve the understanding of swallowing issues in Alzheimer's patients and support their caregivers.
Gender
ALL
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)
About Vanderbilt University Medical Center
Vanderbilt University Medical Center (VUMC) is a leading academic medical center located in Nashville, Tennessee, renowned for its commitment to advancing healthcare through innovative research and clinical excellence. As a prominent sponsor of clinical trials, VUMC integrates cutting-edge scientific inquiry with patient-centered care, supporting a diverse array of studies aimed at enhancing medical knowledge and improving treatment outcomes. With a robust infrastructure and a multidisciplinary team of experts, VUMC fosters collaboration across various fields, ensuring the highest standards of safety and ethical considerations in its research endeavors. Through its dedication to medical discovery and education, VUMC plays a pivotal role in shaping the future of medicine.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Nashville, Tennessee, United States
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported