Vestibular therapy for improving balance in Alzheimer's patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: yagrawa1@jhmi.edu
• Phone: 4105023107

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.