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Clinical Trials/NCT06678100
NCT06678100
Recruiting
Not Applicable

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

Vanderbilt University Medical Center1 site in 1 country240 target enrollmentApril 21, 2025

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Alzheimer Disease
Sponsor
Vanderbilt University Medical Center
Enrollment
240
Locations
1
Primary Endpoint
Swallowing safety
Status
Recruiting
Last Updated
10 months ago

Overview

Brief 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 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.

Registry
clinicaltrials.gov
Start Date
April 21, 2025
End Date
February 2028
Last Updated
10 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Cara Donohue, Ph.D. CCC-SLP

Assistant Professor, Director of Medical Speech-Language Pathology

Vanderbilt University Medical Center

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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

  • Voluntary cough peak expiratory flow(During baseline visit at time of enrollment)
  • Grip strength(During baseline visit at time of enrollment.)
  • Tongue strength(During baseline visit at time of enrollment.)
  • Swallowing and Eating Related Fatigue Questionnaire (SERF)(During baseline visit at time of enrollment.)
  • Swallowing Related Quality of Life Questionnaire (SWAL-QOL)(During baseline visit at time of enrollment.)
  • Eating Assessment Tool 10 (EAT-10)(During baseline visit at time of enrollment.)
  • Caregiver Analysis of Reported Experiences with Swallowing Disorders (CARES) Questionnaire(During baseline visit at time of enrollment.)
  • Caregiver Self-Assessment Questionnaire(During baseline visit at time of enrollment.)
  • 3 oz water swallow test(During baseline visit at time of enrollment.)
  • Reflex cough(During baseline visit at time of enrollment.)
  • Screening for Oral Frailty Tool (SOFT)(During baseline visit at time of enrollment.)

Study Sites (1)

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