Interventions for Alzheimer's patients with swallowing difficulties
Impact of Novel Rehabilitative Approaches for Dysphagia in Patients With Alzheimer's Disease and Related Dementias
This study is testing different ways to help Alzheimer's patients with swallowing difficulties to see if they can improve their swallowing and reduce the risk of pneumonia.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 152 (estimated) |
| Ages | 50 Years to 99 Years |
| Sex | All |
| Sponsor | University of Wisconsin, Madison Academic / other |
| Locations | 1 site (Madison, Wisconsin) |
| Trial ID | NCT03682081 on ClinicalTrials.gov |
What this trial studies
This project aims to develop effective rehabilitative interventions for dysphagia in patients with Alzheimer's Disease and related dementias, who are at risk for pneumonia. The study involves a randomized clinical trial where patient-caregiver dyads will be assigned to one of four groups: lingual strengthening, saliva substitute use, a combination of both, or usual care. Outcomes related to saliva and swallowing will be assessed before and after an 8-week intervention period. The trial will also identify which subgroups of patients are most likely to benefit from these interventions.
Who should consider this trial
Good fit: Ideal candidates are English-speaking individuals aged 50-99 with mild to moderate Alzheimer's Disease or related dementias, living at home or in care facilities, and who have an actively involved caregiver.
Not a fit: Patients with dementia primarily due to cerebrovascular disease or those with structural deformities affecting swallowing may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve swallowing function and reduce pneumonia risk in Alzheimer's patients.
How similar studies have performed: Other studies have shown promise in using similar rehabilitative approaches for dysphagia in dementia patients, suggesting potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria (patients): * Age 50-99 * English speaking * Diagnosis of dementia or cognitive impairment or memory loss * Clinical Dementia Rating (CDR) scale score between 0.5 and 2.0 * Actively involved caregiver * Resides at home, assisted living facility, or long-term care facility Inclusion criteria (caregivers) * English speaking * Age 18 and older * Contact with patient at least 1 time a week * Has access to a working telephone Exclusion criteria (patients): * Dementia due to cerebrovascular disease as primary cause * History of head and neck cancer or other structural deformity that can affect swallowing * Allergy to barium * Currently breastfeed or pregnant or planning to become pregnant Exclusion criteria (caregivers): * Lacks ability to give consent
Where this trial is running
Madison, Wisconsin
- University of Wisconsin-Madison — Madison, Wisconsin, United States (Recruiting)
Study contacts
- Principal investigator: Nicole Rogus-Pulia, PhD, CCC-SLP — University of Wisconsin, Madison
- Study coordinator: Sara Gustafson, MS, CCC-SLP
- Email: segustafson@wisc.edu
- Phone: 608-262-9995
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.