Vestibular therapy for improving balance in Alzheimer's patients

Vestibular Therapy in Alzheimer's Disease

This study is testing if vestibular therapy can help improve balance and reduce falls in people with Alzheimer's disease.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 60 Years and up
• Sex: All
• Sponsor: Johns Hopkins University (Academic / other)
• Locations: 1 site (Baltimore, Maryland)
• Trial ID: NCT03799991 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness of vestibular therapy in reducing falls among patients with Alzheimer's disease, who often experience balance and mobility issues. The study will involve a randomized controlled design, comparing vestibular physical therapy to an active control group. Participants will undergo vestibular physiologic testing, balance and gait assessments, and neurocognitive testing over an 8-week period. The goal is to determine if vestibular therapy can enhance balance stability in this population, which has not been previously studied.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 60 and older with a diagnosis of mild to moderate Alzheimer's disease and evidence of vestibular loss.

Not a fit: Patients with severe cognitive impairment who cannot provide informed consent or participate in the therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this therapy could significantly reduce the risk of falls in Alzheimer's patients, improving their safety and quality of life.

How similar studies have performed: This approach is novel, as vestibular therapy has not been previously tested in Alzheimer's patients, although it has shown effectiveness in improving balance in healthy older adults.

Eligibility criteria

Inclusion Criteria:

* Diagnosis of AD based on the National Institute on Aging-Alzheimer Association 2011 criteria that is mild-moderate (CDR=0.5-2).
* Age ≥ 60 years.
* Vestibular loss defined as bilaterally impaired vestibular responses (semicircular canal or otolith responses).
* Able to participate in study procedures including vestibular physiologic testing, balance and gait assessment, neurocognitive testing, and VT or active control.
* Able to give informed consent, as further detailed in the Human Subjects section. The investigators anticipate that individuals who are too impaired to provide informed consent would also not be able to effectively participate in VT or active control.
* Presence of a caregiver, defined as an individual who spends at least 10 hours per week with the patient. The caregiver must be able to participate in study procedures, specifically the text-messaging system. Both the VT and active control involve 8 weeks of once weekly visits and daily home exercises, and the investigators believe a caregiver would increase the likelihood of successful completion of either therapy.

Exclusion Criteria:

* Diagnosis of severe AD (CDR≥3).
* Diagnosis of mild cognitive impairment or diagnosis of non-AD dementia, for example Parkinson's disease dementia, Dementia with Lewy Bodies, vascular dementia, fronto-temporal dementia, and primary progressive aphasia.
* Deemed unable to participate in study procedures and VT or active control, (e.g. patients with significant medical comorbidities, excessive agitation, or use of mobility aids such as a cane or walker.)
* Use of daily vestibular suppressant medications, specifically anti-histamines and benzodiazepines, as this can alter the response to VT.
* Lack of availability to participate in 8 weeks of VT or active control.

Where this trial is running

Baltimore, Maryland

• Johns Hopkins University School of Medicine — Baltimore, Maryland, United States (Recruiting)

Study contacts

• Principal investigator: Yuri Agrawal, MD — Johns Hopkins University
• Study coordinator: Yuri Agrawal, MD

Conditions Vestibular Diseases; Vestibular Disorder; Alzheimer Disease