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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Vanderbilt University Medical Center
  Nashville, Tennessee, United States Recruiting

Study contacts

• Study coordinator: Cara Donohue, PhD CCC-SLP
• Email: cara.donohue@vumc.org
• Phone: 615-852-5085

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.