RECRUITING

Vestibular Therapy in Alzheimer's Disease

Conditions

Vestibular Diseases Vestibular Disorder Alzheimer Disease

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Vestibular Therapy in Alzheimer's Disease

Quick Facts

Study Start:2021-03-01

Study Completion:2027-06-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT03799991

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:60 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Study Contact

Yuri Agrawal, MD

CONTACT

4105023107

yagrawa1@jhmi.edu

Principal Investigator

Yuri Agrawal, MD

PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Study Locations (Sites)

Johns Hopkins University School of Medicine

Baltimore, Maryland, 21287

United States

Collaborators and Investigators

Sponsor: Johns Hopkins University

Yuri Agrawal, MD, PRINCIPAL_INVESTIGATOR, Johns Hopkins University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-03-01

Study Completion Date2027-06-30

Study Record Updates

Study Start Date2021-03-01

Study Completion Date2027-06-30

Terms related to this study

Additional Relevant MeSH Terms

Vestibular Diseases
Vestibular Disorder
Alzheimer Disease