Vestibular Therapy in Alzheimer's Disease
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 60 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether vestibular therapy, which works on the inner ear balance system, can reduce falls in people with Alzheimer's disease. It is for adults age 60 or older with mild to moderate Alzheimer's disease and reduced inner ear balance function.
Nearly 2 out of 3 patients with Alzheimer's disease (AD) experience problems with balance and mobility, which places such patients at increased risk of falling. The vestibular (inner ear balance) system plays an important role in balance stability, and vestibular therapy (VT) is well-known to improve balance function in healthy older adults. In this study, the investigators will conduct a first-in-kind randomized clinical trial to evaluate whether vestibular therapy improves reduces falls in patients with AD, in whom this treatment has never been studied.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Have mild to moderate Alzheimer's disease diagnosed using the study's standards.
- Be age 60 or older.
- Have reduced inner ear balance function on both sides.
- Be able to take part in inner ear, balance, walking, and thinking tests, and in the assigned study program.
- Be able to understand the study and agree to take part.
- Have a caregiver who spends at least 10 hours a week with you and can take part in study tasks, including text messages.
- Be able to attend one visit a week for 8 weeks and do daily home exercises.
Who can't join
- Have severe Alzheimer's disease.
- Have mild cognitive impairment, meaning milder problems with memory or thinking, or a type of dementia other than Alzheimer's disease.
- Be unable to take part in study tests or either study program, such as because of major health problems, severe agitation, or use of a cane or walker.
- Take daily medicines that reduce inner ear balance signals, specifically antihistamines or benzodiazepines.
- Be unavailable for the 8-week study program.
Simplified for readability. The official criteria below are what the study team uses.
Official 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.
Study sites (1)
MD
- Johns Hopkins University School of Medicine · Baltimore, MD 21287Yuri Agrawal · Study contactJohn Carey, MD · Principal investigatorMore trials in Baltimore