<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03799991</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00273752</org_study_id>
    <nct_id>NCT03799991</nct_id>
  </id_info>
  <brief_title>Vestibular Therapy in Alzheimer's Disease</brief_title>
  <official_title>Vestibular Therapy in Alzheimer's Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johns Hopkins University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Johns Hopkins University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Nearly 2 out of 3 patients with Alzheimer's disease (AD) experience problems with balance and&#xD;
      mobility, which places such patients at increased risk of falling. The vestibular (inner ear&#xD;
      balance) system plays an important role in balance stability, and vestibular therapy (VT) is&#xD;
      well-known to improve balance function in healthy older adults. In this study, the&#xD;
      investigators will conduct a first-in-kind randomized clinical trial to evaluate whether&#xD;
      vestibular therapy improves reduces falls in patients with AD, in whom this treatment has&#xD;
      never been studied.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">March 1, 2021</start_date>
  <completion_date type="Anticipated">June 30, 2024</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2024</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of participant falls</measure>
    <time_frame>1 year</time_frame>
    <description>Incidence of falls over a 1-year follow-up period</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Vestibular Diseases</condition>
  <condition>Vestibular Disorder</condition>
  <condition>Alzheimer Disease</condition>
  <arm_group>
    <arm_group_label>Vestibular therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Vestibular therapy (Vestibular physical therapy) entails an 8-week course of exercises delivered by a physical therapist designed to improve vestibular function.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Active control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The active control regimen consists of eye movement exercises (e.g. smooth pursuit eye movements) and also general conditioning exercises (e.g. range of motion exercises, lifting light weights with the arms and legs). This regimen is &quot;vestibular neutral&quot; in that head movements which specifically challenge the vestibular system are avoided.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Vestibular physical therapy</intervention_name>
    <description>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.</description>
    <arm_group_label>Vestibular therapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Active control</intervention_name>
    <description>Strength and flexibility exercises that do not involve head movements.</description>
    <arm_group_label>Active control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of AD based on the National Institute on Aging-Alzheimer Association 2011&#xD;
             criteria that is mild-moderate (CDR=0.5-2).&#xD;
&#xD;
          -  Age ≥ 60 years.&#xD;
&#xD;
          -  Vestibular loss defined as bilaterally impaired vestibular responses (semicircular&#xD;
             canal or otolith responses).&#xD;
&#xD;
          -  Able to participate in study procedures including vestibular physiologic testing,&#xD;
             balance and gait assessment, neurocognitive testing, and VT or active control.&#xD;
&#xD;
          -  Able to give informed consent, as further detailed in the Human Subjects section. The&#xD;
             investigators anticipate that individuals who are too impaired to provide informed&#xD;
             consent would also not be able to effectively participate in VT or active control.&#xD;
&#xD;
          -  Presence of a caregiver, defined as an individual who spends at least 10 hours per&#xD;
             week with the patient. The caregiver must be able to participate in study procedures,&#xD;
             specifically the text-messaging system. Both the VT and active control involve 8 weeks&#xD;
             of once weekly visits and daily home exercises, and the investigators believe a&#xD;
             caregiver would increase the likelihood of successful completion of either therapy.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of severe AD (CDR≥3).&#xD;
&#xD;
          -  Diagnosis of mild cognitive impairment or diagnosis of non-AD dementia, for example&#xD;
             Parkinson's disease dementia, Dementia with Lewy Bodies, vascular dementia,&#xD;
             fronto-temporal dementia, and primary progressive aphasia.&#xD;
&#xD;
          -  Deemed unable to participate in study procedures and VT or active control, (e.g.&#xD;
             patients with significant medical comorbidities, excessive agitation, or use of&#xD;
             mobility aids such as a cane or walker.)&#xD;
&#xD;
          -  Use of daily vestibular suppressant medications, specifically anti-histamines and&#xD;
             benzodiazepines, as this can alter the response to VT.&#xD;
&#xD;
          -  Lack of availability to participate in 8 weeks of VT or active control.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yuri Agrawal, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Johns Hopkins University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Yuri Agrawal, MD</last_name>
    <phone>4105023107</phone>
    <email>yagrawa1@jhmi.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Johns Hopkins University School of Medicine</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21287</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yuri Agrawal</last_name>
    </contact>
    <investigator>
      <last_name>John Carey, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>January 8, 2019</study_first_submitted>
  <study_first_submitted_qc>January 8, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 10, 2019</study_first_posted>
  <last_update_submitted>December 13, 2022</last_update_submitted>
  <last_update_submitted_qc>December 13, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 14, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vestibular Diseases</mesh_term>
    <mesh_term>Alzheimer Disease</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03799991
org study id: IRB00273752
nct id: NCT03799991
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Number of participant falls
time frame: 1 year
description: Incidence of falls over a 1-year follow-up period
arm group label: Vestibular therapy
arm group type: Experimental
description: Vestibular therapy (Vestibular physical therapy) entails an 8-week course of exercises delivered by a physical therapist designed to improve vestibular function.
arm group label: Active control
arm group type: Active Comparator
description: The active control regimen consists of eye movement exercises (e.g. smooth pursuit eye movements) and also general conditioning exercises (e.g. range of motion exercises, lifting light weights with the arms and legs). This regimen is "vestibular neutral" in that head movements which specifically challenge the vestibular system are avoided.
intervention type: Behavioral
intervention name: Vestibular physical therapy
description: 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.
arm group label: Vestibular therapy
intervention type: Behavioral
intervention name: Active control
description: Strength and flexibility exercises that do not involve head movements.
arm group label: Active control
criteria: 
gender: All
minimum age: 60 Years
maximum age: N/A
healthy volunteers: No
last name: Yuri Agrawal, MD
role: Principal Investigator
affiliation: Johns Hopkins University
last name: Yuri Agrawal, MD
phone: 4105023107
email: yagrawa1@jhmi.edu
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Sponsor
mesh term: Vestibular Diseases
mesh term: Alzheimer Disease
sharing ipd: Undecided