Swallowing Impairments in Adults With and Without Alzheimer's Disease

NCT ID: NCT06678100

Last Updated: 2025-06-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

240 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-04-21

Study Completion Date

2028-02-29

Brief Summary

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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

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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

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Alzheimer Disease Caregiver Burden Healthy Aging Dysphagia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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.


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


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

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 provides consent.


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


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)
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Vanderbilt University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Cara Donohue, Ph.D. CCC-SLP

Assistant Professor, Director of Medical Speech-Language Pathology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Vanderbilt University Medical Center

Nashville, Tennessee, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Cara Donohue, PhD CCC-SLP

Role: CONTACT

615-852-5085

Facility Contacts

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Cara Donohue, PhD CCC-SLP

Role: primary

615-852-5085

Other Identifiers

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25AARG-NTF-1369514

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

241954

Identifier Type: -

Identifier Source: org_study_id

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