What side effects are associated with this type of intervention?

Common treatments for dementia, such as cholinesterase inhibitors (donepezil, galantamine) and NMDA receptor antagonists (memantine), have known side effects. Cholinesterase inhibitors can cause gastrointestinal issues like nausea, vomiting, and diarrhea, as well as muscle cramps, fatigue, and insomnia. Memantine may lead to dizziness, headache, confusion, and constipation. These side effects should be monitored and managed in consultation with a healthcare provider.

What prior FDA approvals exist?

FDA-approved drugs for the treatment of dementia, particularly Alzheimer's disease, include cholinesterase inhibitors such as donepezil, rivastigmine, and galantamine, as well as the NMDA receptor antagonist memantine. These medications aim to improve cognitive function and slow the progression of symptoms. Cholinesterase inhibitors work by increasing levels of acetylcholine in the brain, which can help with memory and cognition, and are relevant to studies on improving swallowing function due to their impact on neural pathways.

What other types of research exist?

Promising novel alternatives to traditional dysphagia rehabilitative interventions for dementia patients include: 1) Telemedicine-based dysphagia management, which allows for remote assessment and therapy, increasing accessibility and convenience. 2) Virtual reality (VR) and augmented reality (AR) therapies, which provide immersive and interactive environments to enhance swallowing exercises. 3) Neuromuscular electrical stimulation (NMES), which uses electrical impulses to stimulate the muscles involved in swallowing. 4) Biofeedback devices that provide real-time visual or auditory feedback to patients during swallowing exercises, improving technique and outcomes. These alternatives offer innovative ways to improve swallowing function in dementia patients.

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Behavioural Intervention

Dysphagia Therapy for Alzheimer's Disease

N/A

Recruiting

Led By Nicole Rogus-Pulia, PhD, CCC-SLP

Research Sponsored by University of Wisconsin, Madison

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients aged 50-99

Diagnosis of dementia or cognitive impairment or memory loss

Must not have

Patients with dementia due to cerebrovascular disease as primary cause

Caregivers lacking ability to give consent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up post-enrollment at approximately days 7, 14, 28, 42, 56, 90, and 180

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a saliva gel and tongue exercises to help people with Alzheimer's who have trouble swallowing. These patients are at risk of pneumonia because they can't swallow well. The saliva gel keeps their mouth moist, and the exercises make their tongue stronger to help with swallowing.

Who is the study for?

This trial is for English-speaking patients aged 50-99 with dementia or memory loss, scoring 0.5-2.0 on the CDR scale, living at home or in assisted living. Caregivers must be over 18, speak English, have weekly contact with the patient and a working phone. Excluded are those with certain cerebrovascular diseases, head/neck cancer history, barium allergies, or pregnancy.

What is being tested?

The study tests tongue strengthening exercises using an Iowa Oral Performance Instrument (IOPI) and Biotene Oral Balance Gel to improve swallowing in Alzheimer's patients to prevent pneumonia.

What are the potential side effects?

Potential side effects may include discomfort from tongue exercises and possible reactions to Biotene Gel like mouth irritation; however specific side effects will depend on individual tolerance.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 50 and 99 years old.

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I have been diagnosed with dementia or significant memory loss.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My dementia is mainly caused by issues with my brain's blood vessels.

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My caregiver cannot legally agree to decisions for me.

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I have had head or neck cancer or a condition that affects my ability to swallow.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ post-enrollment at approximately days 7, 14, 28, 42, 56, 90, and 180

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~post-enrollment at approximately days 7, 14, 28, 42, 56, 90, and 180

This trial's timeline: 3 weeks for screening, Varies for treatment, and post-enrollment at approximately days 7, 14, 28, 42, 56, 90, and 180 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Pharyngeal residue measured with the Normalized Residue Ratio Scale (NRRS)

Secondary study objectives

Change in Dynamic Imaging Grade of Swallowing Toxicity (DIGEST) scores

Change in Functional Oral Intake Scale

Change in Lingual strength-maximal isometric lingual pressures

+7 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Saliva Substitute and Lingual Strengthening InterventionExperimental Treatment2 Interventions

Each patient-caregiver dyad will be provided with a commercially available gel-based saliva substitute, Biotene® Oral Balance Gel that will be applied regularly to the oral cavity for 8 weeks. Each dyad will also be trained in the lingual strengthening protocol and will undergo this intervention for 8 weeks. Isometric tongue strengthening will be facilitated by the Iowa Oral Performance Instrument (IOPI) device.

Group II: Saliva Substitute InterventionExperimental Treatment1 Intervention

Each patient-caregiver dyad will be provided with a commercially available gel-based saliva substitute, Biotene® Oral Balance Gel that will be applied to the oral cavity regularly for 8 weeks.

Group III: Lingual Strengthening InterventionExperimental Treatment1 Intervention

Patient-caregiver dyads will be trained in the lingual strengthening protocol and patients will undergo this intervention for 8 weeks. Isometric tongue strengthening will be facilitated by the Iowa Oral Performance Instrument (IOPI) device.

Group IV: Usual careActive Control1 Intervention

Usual care groups will receive standard swallowing interventions identified by the Speech-Language Pathologist as appropriate to treat the patient's dysphagia and common in clinical practice. Such treatment would likely consist of dietary (e.g., thickened liquids or pureed foods) or postural compensatory strategies (e.g., chin down posture while swallowing). No progressive lingual strengthening approaches or regimented salivary substitute protocols are utilized.

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for dementia include cholinesterase inhibitors (e.g., donepezil, rivastigmine) and NMDA receptor antagonists (e.g., memantine). Cholinesterase inhibitors work by increasing levels of acetylcholine, a neurotransmitter important for memory and learning, which can help improve cognitive function and slow symptom progression. NMDA receptor antagonists regulate glutamate activity to prevent excitotoxicity, which can protect neurons from damage. For dementia patients with dysphagia, these treatments are crucial as they may help maintain cognitive and motor functions necessary for safe swallowing. Additionally, specific dysphagia rehabilitative interventions, such as targeted swallowing exercises and texture-modified foods, aim to improve swallowing safety and efficiency, reducing the risk of aspiration and improving overall quality of life.

An Interactive Workshop on Managing Dysphagia in Older Adults With Dementia.Care staff perspective on use of texture modified food in care home residents with dysphagia and dementia.