Vestibular Therapy in Alzheimer's Disease

Alzheimer Disease Clinical Trial

Official title:

Vestibular Therapy in Alzheimer's Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03799991
• Other study ID #: IRB00273752
• Secondary ID: R01AG065259
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: June 30, 2027

Study information

• Verified date: June 2024
• Source: Johns Hopkins University
• Contact: Yuri Agrawal, MD
• Phone: 4105023107
• Email: yagrawa1[@]jhmi.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 30, 2027
• Est. primary completion date: June 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Alzheimer Disease
• Vestibular Diseases
• Vestibular Disorder

Intervention

Behavioral:
• Vestibular physical therapy
Vestibular therapy is a set of exercises delivered by a physical therapist involving head movements. The therapy is delivered over a course of 8 weeks.
• Active control
Strength and flexibility exercises that do not involve head movements.

Locations

Country	Name	City	State
United States	Johns Hopkins University School of Medicine	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participant falls	Incidence of falls over a 1-year follow-up period	1 year