Dysphagia Therapy for Alzheimer's Disease

Overseen By Meredith Mackowicz-Torres, MS, CCC-SLP

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Wisconsin, Madison

Disqualifiers: Cerebrovascular disease, Head/neck cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 9

Duration: 8 weeks

76 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests new therapies to improve swallowing difficulties in people with Alzheimer's and similar dementias, potentially preventing pneumonia. Participants will try various treatments, including tongue-strengthening exercises using a special device (Isometric tongue strengthening facilitated by the Iowa Oral Performance Instrument, or IOPI) and a saliva substitute gel (Biotene Oral Balance Gel). The trial seeks participants diagnosed with dementia who live at home or in a care facility and have a caregiver to assist them. As an unphased trial, this study offers a unique opportunity to explore innovative treatments that could significantly enhance quality of life.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that tongue strengthening exercises using the Iowa Oral Performance Instrument (IOPI) are generally safe. These exercises strengthen the tongue, which is crucial for swallowing. Studies have found this method to be well-tolerated without causing serious side effects.

Biotene Oral Balance Gel is typically safe when used as directed. It alleviates dry mouth by maintaining moisture. However, excessive use can lead to minor issues like stomach discomfort. Rarely, some individuals have reported a feeling of suffocation, though this is uncommon.

Both treatments appear safe based on available data, but it is important to monitor your body's reactions and report any unexpected effects to a healthcare provider. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for dysphagia in Alzheimer's patients because they explore innovative approaches beyond standard care, which often includes dietary adjustments or postural strategies. The isometric tongue strengthening, facilitated by the Iowa Oral Performance Instrument (IOPI), is a standout feature, as it aims to directly enhance muscle strength in the tongue, potentially improving swallowing function. Additionally, the use of a saliva substitute, Biotene® Oral Balance Gel, is being tested for its ability to ease swallowing by keeping the mouth moist. These methods offer a fresh perspective by addressing the physical mechanics of swallowing and oral moisture, which could lead to more effective management of dysphagia in Alzheimer's patients.

What evidence suggests that this trial's treatments could be effective for dysphagia in Alzheimer's patients?

Research has shown that exercises to strengthen the tongue can help older adults, including those with Alzheimer's, swallow better. In this trial, some participants will undergo isometric tongue strengthening using the Iowa Oral Performance Instrument (IOPI). Studies have found that this method strengthens the tongue and can ease swallowing problems, particularly for those with Alzheimer's who struggle with swallowing.

Another group in this trial will use Biotene Oral Balance Gel, which has proven effective for dry mouth. It helps keep the mouth moist, making swallowing easier. While primarily used for dry mouth, it can also improve comfort for those with swallowing issues. Together, these treatments could significantly aid individuals facing swallowing difficulties. ^{6 7 8 9 10}

Who Is on the Research Team?

Nicole Rogus-Pulia, PhD, CCC-SLP

Principal Investigator

University of Wisconsin, Madison

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Clinical Dementia Rating (CDR) scale score between 0.5 and 2.0

Actively involved caregiver

Resides at home or an assisted living facility

Exclusion Criteria

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

Patients with allergy to barium

My caregiver cannot legally agree to decisions for me.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline Assessment

Baseline assessment including sociodemographics, comorbidities, medications, cognitive assessment, and oral health status

1 week

1 visit (in-person)

Treatment

Participants undergo interventions including lingual strengthening and/or saliva substitute use for 8 weeks

8 weeks

Weekly follow-up calls

Follow-up

Participants are monitored for safety and effectiveness after treatment, including changes in salivary production, pneumonia diagnoses, and swallowing quality of life

24 weeks

Follow-up assessments at days 7, 14, 28, 42, 56, 90, and 180

What Are the Treatments Tested in This Trial?

Interventions

• Biotene Oral Balance Gel
• Isometric tongue strengthening facilitated by Iowa Oral Performance Instrument (IOPI)

Trial Overview 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.

How Is the Trial Designed?

Group I: Saliva Substitute and Lingual Strengthening Intervention Experimental Treatment 2 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 Intervention Experimental Treatment 1 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 Intervention Experimental Treatment 1 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 care Active Control 1 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.

Isometric tongue strengthening facilitated by Iowa Oral Performance Instrument (IOPI) is already approved in United States, European Union for the following indications:

Approved in United States as IOPI for:

• Dysphagia rehabilitation
• Swallowing disorders

Approved in European Union as IOPI for:

• Dysphagia rehabilitation
• Swallowing disorders

Who Is Running the Clinical Trial?

University of Wisconsin, Madison

Lead Sponsor

Trials

1,249

Recruited

3,255,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Published Research Related to This Trial

The study involved 50 patients with moderate to severe Alzheimer's disease (AD) and identified specific feeding and swallowing difficulties, such as passivity and distraction, which were more pronounced in patients with greater cognitive impairment (CDR2 and CDR3 groups).

These feeding and swallowing issues were correlated with the severity of communication and swallowing difficulties in AD patients, highlighting the need for targeted support for caregivers and healthcare professionals to manage these challenges effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Swallowing in moderate and severe phases of Alzheimer's disease. Correia, Sde M., Morillo, LS., Jacob Filho, W., et al.[2019]

In a study of six adults with chronic dysphagia due to brain injury, 24 sessions of tongue-pressure resistance training over 11-12 weeks led to significant improvements in tongue strength and swallowing safety, as indicated by better post-treatment tongue pressure and reduced penetration-aspiration scores.

However, some patients experienced worsening pharyngeal residue, suggesting that while the training improved certain aspects of swallowing, it may not address all issues related to dysphagia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of tongue-pressure strength and accuracy training for dysphagia following acquired brain injury. Steele, CM., Bailey, GL., Polacco, RE., et al.[2022]

Tongue strengthening exercises (TSE) significantly improve both anterior and posterior tongue strength compared to control groups, with a notable increase in strength measured in kilopascals (kPa) across 12 studies involving 388 participants.

The greatest improvements in anterior tongue strength were observed in older adults (≥ 65 years), suggesting that TSE could be particularly beneficial for this age group in enhancing swallowing function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of tongue strengthening exercises on tongue muscle strength: a systematic review and meta-analysis of randomized controlled trials. Lin, CJ., Lee, YS., Hsu, CF., et al.[2022]

A three-month feeding intervention for 30 nursing home residents with Alzheimer's disease significantly improved food intake and nutritional status, as evidenced by increased skinfold thickness, arm circumference, serum albumin, and hemoglobin levels (all p < 0.01).

The intervention also enhanced eating compliance, with five out of 22 patients who initially required feeding regaining the ability to self-feed, indicating potential for improved quality of life in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a feeding intervention in patients with Alzheimer's disease and dysphagia. Chen, LL., Li, H., Lin, R., et al.[2022]

The Madison Oral Strengthening Therapeutic (MOST) device was developed to improve tongue muscle strength and address swallowing difficulties, showing promise in both treatment and prevention of muscle atrophy.

The study compared the MOST device to the Iowa Oral Performance Instrument (IOPI) and aimed to determine the best sampling rate for measuring tongue pressure during exercises, highlighting its potential for broader use in healthy aging adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Standardized instrument for lingual pressure measurement. Hewitt, A., Hind, J., Kays, S., et al.[2018]

The Iowa Oral Performance Instrument (IOPI) is a reliable tool for measuring tongue strength and endurance, supported by evidence from 38 studies, primarily involving healthy adults and individuals with conditions like Parkinson's disease and head or neck cancer.

There is emerging evidence for the IOPI's effectiveness in assessing hand strength and endurance, indicating its potential utility beyond just tongue measurements in both healthy and clinical populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review and meta-analysis of measurements of tongue and hand strength and endurance using the Iowa Oral Performance Instrument (IOPI). Adams, V., Mathisen, B., Baines, S., et al.[2022]

In a study of 232 Alzheimer's patients averaging 85.4 years old, decreased skeletal muscle mass was significantly associated with the severity of Alzheimer's disease and poor swallowing function.

Factors such as a clinical dementia rating of 3, low body mass index, and small calf circumference were identified as strong predictors of decreased skeletal muscle, highlighting the need for interventions to address swallowing difficulties in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relationship between skeletal muscle mass and swallowing function in patients with Alzheimer's disease. Takagi, D., Hirano, H., Watanabe, Y., et al.[2018]

In a pilot study involving 31 healthy young subjects, tongue strengthening exercises significantly improved maximum tongue strength compared to a control group that did not exercise, indicating the efficacy of these exercises (p = 0.04).

Both types of tongue exercises, whether using a tongue depressor or the Iowa Oral Performance Instrument, were effective in enhancing tongue function, supporting the idea that targeted exercises can strengthen tongue muscles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of two types of tongue strengthening exercises in young normals. Lazarus, C., Logemann, JA., Huang, CF., et al.[2022]

In a study of 74 elderly adults over 8 weeks, tongue-hold swallowing exercises improved both anterior and posterior tongue strength, while tongue-pressure resistance training significantly increased only anterior tongue strength.

Both types of exercises led to increased salivary flow, with the tongue-pressure resistance training group showing a greater increase, but neither exercise significantly improved subjective oral health scores.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of lingual exercises on oral muscle strength and salivary flow rate in elderly adults: a randomized clinical trial. Lee, KH., Jung, ES., Choi, YY.[2020]

A multi-center randomized controlled trial is being conducted to evaluate the effectiveness of a Stepwise Swallowing Training (SST) program for improving swallowing function in Alzheimer's disease patients, with a follow-up period of 4 weeks.

The SST program, which includes targeted exercises for various swallowing organs, aims to enhance swallowing abilities and reduce the negative impacts of dysphagia, potentially improving patients' eating behavior, daily activities, and nutritional status.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the effectiveness of stepwise swallowing training on dysphagia in patients with Alzheimer's disease: study protocol for a randomized controlled trial. Wu, C., Zhang, K., Ye, J., et al.[2022]

Citations

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A Pilot Study of Perceived Mouth Dryness ... Biotene® products, a hybrid between biopolymer plant mucilage and salivary enzyme–based substitutes, have shown effectiveness for reducing perceived mouth ...

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Interventions for Patients With Alzheimer's Disease and ... The overall purpose of this project is to develop effective dysphagia ... Biotene Oral Balance Gel. Participants will be instructed to apply an ...

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Evaluation of the clinical efficacy of Biotène Oral Balance in ... The objective of the present study was to evaluate the efficacy of Oral Balance saliva substitute in alleviating dry mouth symptoms in a ...

4. withpower.com withpower.com/trial/phase-deglutition-disorders-8-2020-459d9

Dysphagia Therapy for Alzheimer's Disease 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 ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT04323384

Study Details | NCT04323384 | The Effect of Biotene® on ... Participants with xerostomia and/or hyposalivation will demonstrate greater improvement in oral health-related quality of life, improvement in masticatory ...

6. accessdata.fda.gov accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=18976432&pc=LFD

MAUDE Adverse Event Report: BIOTENE ORAL BALANCE GEL On an unknown date, an unknown time after starting biotene oral balance gel, the patient experienced suffocation (serious criteria haleon medically significant) ...

7. biotene.com biotene.com/dry-mouth-products/moisturizing-gel/

Biotène Oralbalance Moisturizing Gel Relieve dry mouth symptoms with Biotène Oralbalance Moisturizing Gel. Use this concentrated formula to soothe and moisturize your mouth at any time.

8. biotene.com biotene.com/dry-mouth-products/moisturizing-gel.html?bvstate=pg:23/ct:r

Biotène Oralbalance Moisturizing Gel Relieve dry mouth symptoms with Biotène Oralbalance Moisturizing Gel. Use this concentrated formula to soothe and moisturize your mouth at any time.

9. drugs.com drugs.com/sfx/biotene-oral-balance-side-effects.html

Biotene Oral Balance Side Effects Excessive consumption can cause minor digestive problems. Numoisyn Liquid: Patients may experience difficulty in swallowing.

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Biotene (Saliva Substitutes) - Uses, Side Effects, and More Find patient medical information for Biotene (Saliva Substitutes) on WebMD including its uses, side effects and safety, interactions, ...