Alzheimer DiseaseNCT06678100
Swallowing Impairments in Adults With and Without Alzheimer's Disease
An observational study of Alzheimer Disease and Caregiver Burden, run by Vanderbilt University Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease, Caregiver Burden, Healthy Aging
- How many people
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Apr 2025to Feb 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
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- able to follow basic directions
- able/willing to provide consent/assent.
- 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
- 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)
Who cannot join
- 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
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- 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.
- not the primary caregiver of an individual with AD
- unwilling to complete questionnaires/semi-structured interview
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Cara Donohue, PhD CCC-SLP, 615-852-5085, cara.donohue@vumc.org
About this study
Official title: 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:
Read more
- 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.
Read the 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.
- Conditions
- Alzheimer Disease, Caregiver Burden, Healthy Aging, Dysphagia
- Medical subject headings
- Alzheimer Disease, Caregiver Burden, Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: During baseline visit at time of enrollment.
Secondary outcomes (11)
Voluntary cough peak expiratory flow
A measure of cough strength
Measured: During baseline visit at time of enrollment
Grip strength
Grip strength be used to quantify clinical frailty using a digital hand dynamometer.
Measured: During baseline visit at time of enrollment.
Tongue strength
Tongue strength will be assessed using the Iowa Oral Pressure Instrument (IOPI).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: During baseline visit at time of enrollment.
Caregiver Self-Assessment Questionnaire
Scores range from 0-16 with higher scores indicating greater caregiver burden
Measured: 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.
Measured: During baseline visit at time of enrollment.
Reflex cough
Participants will undergo reflex cough testing.
Measured: 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.
Measured: During baseline visit at time of enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2024
- Study start21 Apr 2025
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cara Donohue, Ph.D. CCC-SLP, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06678100
- Sponsor's protocol ID
- 241954
- Other IDs
- 25AARG-NTF-1369514
- Status last verified
- May 2026
- First submitted
- 5 Nov 2024
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence and Care Partner Burden of Individuals With Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT06678100
- Acronym / sponsor ID
- 241954
- Conditions
- Alzheimer Disease, Caregiver Burden, Healthy Aging, Dysphagia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- 21 Apr 2025 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 7 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
11 secondary outcomes
Voluntary cough peak expiratory flow
Time frame: During baseline visit at time of enrollment
Grip strength
Time frame: During baseline visit at time of enrollment.
Tongue strength
Time frame: During baseline visit at time of enrollment.
Swallowing and Eating Related Fatigue Questionnaire (SERF)
Time frame: During baseline visit at time of enrollment.
Swallowing Related Quality of Life Questionnaire (SWAL-QOL)
Time frame: During baseline visit at time of enrollment.
Eating Assessment Tool 10 (EAT-10)
Time frame: During baseline visit at time of enrollment.
Caregiver Analysis of Reported Experiences with Swallowing Disorders (CARES) Questionnaire
Time frame: During baseline visit at time of enrollment.
Caregiver Self-Assessment Questionnaire
Time frame: During baseline visit at time of enrollment.
3 oz water swallow test
Time frame: During baseline visit at time of enrollment.
Reflex cough
Time frame: During baseline visit at time of enrollment.
Screening for Oral Frailty Tool (SOFT)
Time frame: During baseline visit at time of enrollment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer Disease and Caregiver Burden, run by Vanderbilt University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cara Donohue, PhD CCC-SLP (615-852-5085, cara.donohue@vumc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Swallowing safety (time frame: During baseline visit at time of enrollment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.