Investigating swallowing issues in adults with and without Alzheimer's disease

Prevalence and Care Partner Burden of Individuals With Alzheimer's Disease

This study is testing how swallowing problems differ between adults with Alzheimer's disease and healthy older adults to see how it affects both the patients and their caregivers.

Quick facts

• Study type: Observational
• Enrollment: 240 (estimated)
• Ages: 60 Years and up
• Sex: All
• Sponsor: Vanderbilt University Medical Center (Academic / other)
• Drugs / interventions: radiation
• Locations: 1 site (Nashville, Tennessee)
• Trial ID: NCT06678100 on ClinicalTrials.gov

What this trial studies

This research evaluates how swallowing function differs between adults with Alzheimer's disease and healthy age-matched individuals. Participants will undergo tests for cough and swallow function, grip and tongue strength, and complete questionnaires. The study also includes caregivers of individuals with Alzheimer's to assess the impact of swallowing impairments on their well-being. The research involves a single in-person visit lasting approximately 1-1.5 hours.

Who should consider this trial

Good fit: Ideal candidates include adults aged 60 and older diagnosed with Alzheimer's disease and healthy adults of the same age group.

Not a fit: Patients under 60 years old or those with other types of dementia or significant medical histories that affect swallowing may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance understanding of swallowing impairments in Alzheimer's patients, potentially leading to better management strategies.

How similar studies have performed: While swallowing impairments in Alzheimer's have been noted, this specific comparative approach is relatively novel and has not been extensively tested.

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)

Where this trial is running

Nashville, Tennessee

• Vanderbilt University Medical Center — Nashville, Tennessee, United States (Recruiting)

Study contacts

• Study coordinator: Cara Donohue, PhD CCC-SLP

Conditions Alzheimer Disease; Caregiver Burden; Healthy Aging; Dysphagia