Vestibular Therapy in Alzheimer's Disease

Phase

N/A

Condition

Vestibular Hypofunction

Treatment

Active control

Vestibular physical therapy

Clinical Study ID

NCT03799991

IRB00273752

R01AG065259

Ages > 60
All Genders

Study 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) 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Diagnosis of AD based on the National Institute on Aging-Alzheimer Association 2011criteria that is mild-moderate (CDR=0.5-2).
Age ≥ 60 years.
Vestibular loss defined as bilaterally impaired vestibular responses (semicircularcanal 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 provideinformed consent would also not be able to effectively participate in VT or activecontrol.
Presence of a caregiver, defined as an individual who spends at least 10 hours perweek with the patient. The caregiver must be able to participate in studyprocedures, specifically the text-messaging system. Both the VT and active controlinvolve 8 weeks of once weekly visits and daily home exercises, and theinvestigators believe a caregiver would increase the likelihood of successfulcompletion of either therapy.

Exclusion

Exclusion Criteria:

Diagnosis of severe AD (CDR≥3).
Diagnosis of mild cognitive impairment or diagnosis of non-AD dementia, for exampleParkinson'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 ofmobility aids such as a cane or walker.)
Use of daily vestibular suppressant medications, specifically anti-histamines andbenzodiazepines, as this can alter the response to VT.
Lack of availability to participate in 8 weeks of VT or active control.

Study Design