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NCT Number: NCT06678100

Swallowing Impairments in Adults With and Without 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.

Recruiting

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location status: Recruiting

Location contact

Cara Donohue, PhD CCC-SLP

CONTACT

[email protected]

615-852-5085

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

for AD cohort:

  • 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.

Exclusion criteria

for AD Cohort:

  • 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/health care decision maker provides consent.

Inclusion criteria

for care partners of individuals with AD will be:

  • care partner of an individual with AD
  • willing to complete questionnaires/participate in an interview.

Exclusion criteria

for Caregivers of Individuals with AD:

  • not the primary caregiver of an individual with AD
  • unwilling to complete questionnaires/semi-structured interview

Inclusion criteria

for community-dwelling adults will be:

  • 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)

Exclusion criteria

for Healthy Cohort:

  • individual <60 years old
  • history of neurological disease
  • history of respiratory disease
  • history of head and neck surgery/head and neck cancer/radiation to head and neck region
  • history of swallowing difficulties
  • Score <25th percentile based on sex/age/education/race on the Montreal Cognitive Assessment (MOCA)

Treatment and study plan

Primary outcomes

  1. Swallowing safety

    Time frame: 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 outcomes

  1. Voluntary cough peak expiratory flow

    Time frame: During baseline visit at time of enrollment

    A measure of cough strength

  2. Grip strength

    Time frame: During baseline visit at time of enrollment.

    Grip strength be used to quantify clinical frailty using a digital hand dynamometer.

  3. Tongue strength

    Time frame: During baseline visit at time of enrollment.

    Tongue strength will be assessed using the Iowa Oral Pressure Instrument (IOPI).

  4. Swallowing and Eating Related Fatigue Questionnaire (SERF)

    Time frame: During baseline visit at time of enrollment.

    Scores on the SERF range 0-48 with higher scores indicating greater impairment.

  5. Swallowing Related Quality of Life Questionnaire (SWAL-QOL)

    Time frame: During baseline visit at time of enrollment.

    Scores on the SWAL-QOL range from 0-100 with lower scores indicating greater impairment.

  6. Eating Assessment Tool 10 (EAT-10)

    Time frame: During baseline visit at time of enrollment.

    The EAT-10 contains 10 questions (score range: 0-40), higher scores indicate greater impairment.

  7. Caregiver Analysis of Reported Experiences with Swallowing Disorders (CARES) Questionnaire

    Time frame: During baseline visit at time of enrollment.

    Scores on the CARES range from 0-26 with higher scores indicating greater caregiver burden.

  8. Caregiver Self-Assessment Questionnaire

    Time frame: During baseline visit at time of enrollment.

    Scores range from 0-16 with higher scores indicating greater caregiver burden

  9. 3 oz water swallow test

    Time frame: 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.

  10. Reflex cough

    Time frame: During baseline visit at time of enrollment.

    Participants will undergo reflex cough testing.

  11. Screening for Oral Frailty Tool (SOFT)

    Time frame: During baseline visit at time of enrollment.

    Oral frailty will be assessed as present/absent using the Screening for Oral Frailty Tool.

Study contacts

Contact information is provided by the study sponsor or research team.

Cara Donohue, PhD CCC-SLP

CONTACT

[email protected]

615-852-5085

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Nov 7, 2024
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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