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Swallowing Impairments in Adults With and Without Alzheimer's Disease

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
60 Years and older
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares swallowing in adults age 60 and older with and without Alzheimer's disease. Participants will have cough, swallowing, grip, and tongue strength tests and answer questions. Primary caregivers will also answer questions about how swallowing problems affect them.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Adults in both groups must be age 60 or older.
  • The Alzheimer's group must have a diagnosis from a brain doctor, confirmed by scans, a spinal tap, or behavior tests.
  • Both adult groups must have no history of other brain or nerve diseases. The entry rules allow a past stroke if no symptoms remain.
  • Both adult groups must have no history of lung or breathing diseases, head or neck surgery, head or neck cancer, or radiation treatment to those areas.
  • Adults with Alzheimer's must eat or drink something by mouth and follow simple directions.
  • Adults with Alzheimer's must be able and willing to give consent or agree to take part with consent from a legal guardian or health care decision maker.
  • Healthy adults living in the community must report no past swallowing problems. Their memory and thinking test score must be at or above the 25th percentile compared with people of similar sex, age, education, and race.
  • Care partners must care for someone with Alzheimer's and be willing to answer questionnaires or take part in an interview.

Who can't join

  • Adults in either group who are younger than 60.
  • People in the Alzheimer's group who have another type of dementia.
  • Adults with a history of brain, nerve, lung, or breathing diseases. The entry rules make an exception for a stroke with no remaining symptoms.
  • Adults with past head or neck surgery, head or neck cancer, or radiation treatment to those areas.
  • Adults with Alzheimer's who take no food or drink by mouth or cannot follow simple directions.
  • Adults with Alzheimer's who cannot give consent or agree to join with consent from a legal guardian or health care decision maker. The study uses a consent-understanding test with a cutoff score of 15.
  • Healthy adults with past swallowing problems or a memory and thinking test score below the 25th percentile for their comparison group.
  • Caregivers who are not the primary caregiver or are unwilling to answer questionnaires or take part in an interview.

Simplified for readability. The official criteria below are what the study team uses.

Official 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 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)

Study sites (1)

TN