Swallowing Impairments in Adults With and Without Alzheimer's Disease

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

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.

Study Overview

• Status: Recruiting
• Conditions: Alzheimer Disease; Caregiver Burden; Dysphagia; Healthy Aging

Detailed Description

This study will involve one in-person research visit that will last approximately 1-1.5 hours and will consist of a screening, cough testing, swallow function testing, assessments of hand grip and tongue strength, and completion of questionnaires. Caregivers of those with Alzheimer's disease will also complete questionnaires.

• Study Type: Observational
• Enrollment (Estimated): 240

Contacts and Locations

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

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Recruiting
      • Vanderbilt University Medical Center
      • Contact: Cara Donohue, PhD CCC-SLP; Phone Number: 615-852-5085; Email: cara.donohue@vumc.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

The overall objective of this proposal is to evaluate swallow function in 80 healthy adults and 80 individuals with AD and to evaluate caregiver perceptions of swallow function and burden in 80 caregivers of individuals with AD. Thus, this study will enroll healthy adults, individuals with AD, and caregivers of individuals with AD.

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Adults with Alzheimer's Disease and their caregivers; Adults with a diagnosis of Alzheimer's disease and their caregivers will be enrolled in this study.
Healthy community dwelling adults; Healthy adults ≥ 60 years old with no prior history of neurological or respiratory diseases, swallowing impairments, or history of head and neck surgery, cancer, or radiation to the head or neck will be enrolled in this study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Swallowing safety	The penetration aspiration scale is a validated 8-point ordinal rating scale that measures the depth of airway invasion and the patient's response during swallowing. Scores range from 1 to 8 with a score of 1 indicating a safe swallow (best score) and 8 indicating silent aspiration (worst score).	During baseline visit at time of enrollment.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tongue strength	Tongue strength will be assessed using the Iowa Oral Pressure Instrument (IOPI).	During baseline visit at time of enrollment.
Voluntary cough peak expiratory flow	A measure of cough strength	During baseline visit at time of enrollment
Grip strength	Grip strength be used to quantify clinical frailty using a digital hand dynamometer.	During baseline visit at time of enrollment.
Swallowing and Eating Related Fatigue Questionnaire (SERF)	Scores on the SERF range 0-48 with higher scores indicating greater impairment.	During baseline visit at time of enrollment.
Swallowing Related Quality of Life Questionnaire (SWAL-QOL)	Scores on the SWAL-QOL range from 0-100 with lower scores indicating greater impairment.	During baseline visit at time of enrollment.
Eating Assessment Tool 10 (EAT-10)	The EAT-10 contains 10 questions (score range: 0-40), higher scores indicate greater impairment.	During baseline visit at time of enrollment.
Caregiver Analysis of Reported Experiences with Swallowing Disorders (CARES) Questionnaire	Scores on the CARES range from 0-26 with higher scores indicating greater caregiver burden.	During baseline visit at time of enrollment.
Caregiver Self-Assessment Questionnaire	Scores range from 0-16 with higher scores indicating greater caregiver burden	During baseline visit at time of enrollment.
3 oz water swallow test	Participants will be given a cup of three ounces of water and instructed to drink the water continuously. Fail criteria includes interrupted drinking and/or coughing/throat clearing during or immediately following the drinking task.	During baseline visit at time of enrollment.
Reflex cough	Participants will undergo reflex cough testing.	During baseline visit at time of enrollment.
Screening for Oral Frailty Tool (SOFT)	Oral frailty will be assessed as present/absent using the Screening for Oral Frailty Tool.	During baseline visit at time of enrollment.

Collaborators and Investigators

• Sponsor: Vanderbilt University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): April 21, 2025
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2028

Study Registration Dates

• First Submitted: November 5, 2024
• First Submitted That Met QC Criteria: November 5, 2024
• First Posted (Actual): November 7, 2024

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 6, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Behavioral Symptoms; Digestive System Diseases; Gastrointestinal Diseases; Neurocognitive Disorders; Dementia; Tauopathies; Neurodegenerative Diseases; Esophageal Diseases; Otorhinolaryngologic Diseases; Pharyngeal Diseases; Stress, Psychological; Behavior; Caregiver Burden; Alzheimer Disease; Deglutition Disorders
• Other Study ID Numbers: 241954; 25AARG-NTF-1369514 (Other Grant/Funding Number: Alzheimer's Association)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No