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Vestibular Therapy for Alzheimer's Disease

N/A

Recruiting

Led By Yuri Agrawal, MD

Research Sponsored by Johns Hopkins University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Must not have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial will study whether vestibular therapy, which is known to improve balance in healthy adults, can also reduce falls in patients with Alzheimer's disease.

Who is the study for?

This trial is for people over 60 with mild-to-moderate Alzheimer's who have balance issues due to inner ear problems. They need a caregiver available and must be able to do certain tests and therapy sessions. Those with severe Alzheimer's, other dementias, or conditions that limit participation (like needing a cane) can't join.

What is being tested?

The study is testing if vestibular therapy, which helps improve balance by focusing on the inner ear system, can reduce falls in Alzheimer's patients. Participants will either receive this special therapy or an active control treatment in a randomized setup.

What are the potential side effects?

Vestibular physical therapy generally has minimal side effects but may include temporary dizziness or nausea during exercises designed to address balance disorders.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with mild to moderate Alzheimer's disease.

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I am 60 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not taking daily medications for dizziness, like anti-histamines or benzodiazepines.

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I cannot commit to 8 weeks of the treatment or control program.

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I have been diagnosed with a form of dementia that is not Alzheimer's.

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I have been diagnosed with severe Alzheimer's disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of participant falls

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Vestibular therapyExperimental Treatment1 Intervention

Vestibular therapy (Vestibular physical therapy) entails an 8-week course of exercises delivered by a physical therapist designed to improve vestibular function.

Group II: Active controlActive Control1 Intervention

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.

0 / 6Eligibility criteria met