Swallowing Impairments in Adults With and Without Alzheimer's Disease

Recruiting

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

• Registration Number: NCT06678100
• Lead Sponsor: Vanderbilt University Medical Center

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.

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 Timeline

• Study First Submitted: 2024-11-05
• Study First Submitted QC: 2024-11-05
• Study First Posted: 2024-11-07
• Study Start: 2025-04-21
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-21
• Last Update Posted: 2025-05-23
• Primary Completion: 2027-02
• Study Completion: 2028-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Swallowing safety	During baseline visit at time of enrollment.	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).

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States