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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up post-enrollment at approximately days 7, 14, 28, 42, 56, 90, and 180
Awards & highlights
Study Summary
This trial is testing whether a new dysphagia therapy can help reduce the risk of pneumonia in patients with Alzheimer's Disease and related dementias.
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.Check my eligibility
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.See study design
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 belowSelect...
I am between 50 and 99 years old.
Select...
I have been diagnosed with dementia or significant memory loss.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Pharyngeal residue measured with the Normalized Residue Ratio Scale (NRRS)
Secondary outcome measures
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 moreTrial 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.
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Who is running the clinical trial?
University of Wisconsin, MadisonLead Sponsor
1,183 Previous Clinical Trials
3,167,435 Total Patients Enrolled
8 Trials studying Dementia
1,684 Patients Enrolled for Dementia
National Institute on Aging (NIA)NIH
1,671 Previous Clinical Trials
28,016,911 Total Patients Enrolled
266 Trials studying Dementia
23,625,208 Patients Enrolled for Dementia
Nicole Rogus-Pulia, PhD, CCC-SLPPrincipal InvestigatorUniversity of Wisconsin, Madison
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My dementia is mainly caused by issues with my brain's blood vessels.I am between 50 and 99 years old.My caregiver cannot legally agree to decisions for me.I have been diagnosed with dementia or significant memory loss.I have had head or neck cancer or a condition that affects my ability to swallow.
Research Study Groups:
This trial has the following groups:- Group 1: Lingual Strengthening Intervention
- Group 2: Saliva Substitute and Lingual Strengthening Intervention
- Group 3: Usual care
- Group 4: Saliva Substitute Intervention
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Do seniors qualify for inclusion in this clinical experiment?
"This investigation is aimed at those aged 50 to 99. There are 41 studies on the topic for minors, while 818 trials are available for senior citizens."
Answered by AI
How many participants is the research team recruiting for this trial?
"Yes, the data accessible through clinicaltrials.gov demonstrates that this medical experiment is presently accepting qualified applicants. It was initially announced on September 25th 2020 and edited most recently on June 9th 2022 with an aim to recruit 152 participants from one site."
Answered by AI
Are there any opportunities to participate in this experiment presently?
"This clinical trial is currently recruiting for participants. As per the information found on clinicaltrials.gov, it was initially posted in September 2020 and most recently updated June 2022."
Answered by AI
What criteria must be met to qualify for enrollment in this medical research program?
"This medical trial aims to enrol 152 individuals suffering from Alzheimer's disease who are between the age of 50 and 99. To be eligible, each patient must possess a Clinical Dementia Rating (CDR) scale score ranging from 0.5 to 2.0; in addition, they must speak English fluently and have an actively involved caregiver aged 18 or older with contact at least once per week as well as access to a functioning telephone line."
Answered by AI
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