No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
60 and older
Sex
Any
Study type
Observational
Participants needed
240 (estimated)
Sponsor
Vanderbilt University Medical Center · Other
Who this trial is looking for
This trial is looking for adults aged 60 and older, both with and without Alzheimer's disease, to study swallowing abilities. Participants will undergo tests and complete questionnaires to better understand swallowing function.
Are You a Good Fit for This Trial?
You may be able to join if
I am 60 years old or older.
I have been diagnosed with Alzheimer's disease by a neurologist.
I have not had other neurological diseases.
I do not have a history of respiratory diseases.
I consume some form of oral intake.
I can follow basic directions.
I am able and willing to provide consent.
You may not be able to join if
I am younger than 60 years old.
I have been diagnosed with another type of dementia.
I have a history of neurological or respiratory diseases.
I have had head and neck surgery or cancer.
I am not consuming any oral intake.
I cannot follow basic directions.
I cannot provide consent.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 swallo…
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.
Trial Locations
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City
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Status
Eligibility Criteria
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…
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)
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