Status:
RECRUITING
Vestibular Therapy in Alzheimer's Disease
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
National Institute on Aging (NIA)
Conditions:
Vestibular Diseases
Vestibular Disorder
Eligibility:
All Genders
60+ years
Phase:
NA
Brief Summary
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) syst...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 22 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 26 2027
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03799991
Start Date
August 22 2022
End Date
August 26 2027
Last Update
January 8 2025
Active Locations (1)
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1
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States, 21287