Swallowing Impairments in Adults With and Without Alzheimer's Disease

NCT06678100 | Recruiting

• 2 other identifiers: 24195425AARG-NTF-1369514
• Study Type: observational
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer Disease; Caregiver Burden; Healthy Aging; Dysphagia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Voluntary cough peak expiratory flow

  During baseline visit at time of enrollment

• Grip strength

  During baseline visit at time of enrollment.

• Tongue strength

  During baseline visit at time of enrollment.

• Swallowing and Eating Related Fatigue Questionnaire (SERF)

  During baseline visit at time of enrollment.

• Swallowing Related Quality of Life Questionnaire (SWAL-QOL)

  During baseline visit at time of enrollment.

Study Arms (2)

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.

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.

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• adult ≥60 years old
• diagnosis of AD by a neurologist (confirmed with imaging, spinal tap, behavioral testing)
• no prior history of other neurological diseases (aside from stroke which has resolved with no current symptoms)
• no prior history of respiratory diseases
• no prior history of head and neck surgery/head and neck cancer/radiation to head and neck region
• consuming some form of oral intake
• able to follow basic directions
• able/willing to provide consent/assent.

You may not qualify if:

• individual \<60 years old
• Diagnosis of another type of dementia
• History of neurological/respiratory diseases
• History of head and neck surgery/head and neck cancer/radiation to head and neck region
• not consuming any oral intake
• Unable to follow basic directions
• 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.
• care partner of an individual with AD
• willing to complete questionnaires/participate in an interview.
• not the primary caregiver of an individual with AD
• unwilling to complete questionnaires/semi-structured interview
• adult ≥60 years old
• no prior history of neurological diseases (aside from stroke which has resolved with no current symptoms)
• no prior history of respiratory diseases
• \) 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)

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease; Caregiver Burden; Deglutition Disorders

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Stress, Psychological; Behavioral Symptoms; Behavior; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Central Study Contacts

Cara Donohue, PhD CCC-SLP

CONTACT

615-852-5085; cara.donohue@vumc.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Director of Medical Speech-Language Pathology

Study Record Dates

• First Submitted: November 5, 2024
• First Posted: November 7, 2024
• Study Start: April 21, 2025
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2028
• Last Updated: June 19, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)