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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I have been diagnosed with mild to moderate Alzheimer's disease.
Select...
I am 60 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of participant falls
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.
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Who is running the clinical trial?
Johns Hopkins UniversityLead Sponsor
2,262 Previous Clinical Trials
14,823,064 Total Patients Enrolled
National Institute on Aging (NIA)NIH
1,672 Previous Clinical Trials
28,018,563 Total Patients Enrolled
Yuri Agrawal, MDPrincipal InvestigatorJohns Hopkins University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not taking daily medications for dizziness, like anti-histamines or benzodiazepines.You have problems with balance and dizziness due to issues with your inner ear.I have been diagnosed with mild to moderate Alzheimer's disease.I have a caregiver who can spend at least 10 hours a week with me and participate in study procedures.I cannot commit to 8 weeks of the treatment or control program.I am unable to take part in the study due to health issues or need for mobility aids.I have been diagnosed with a form of dementia that is not Alzheimer's.I can do balance, walking, thinking tests, and therapy or control activities.I have been diagnosed with severe Alzheimer's disease.I am 60 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Vestibular therapy
- Group 2: Active control
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Alzheimer's Disease Patient Testimony for trial: Trial Name: NCT03799991 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the total number of subjects participating in this research?
"Affirmative. Clinicaltrials.gov hosts information confirming that this medical trial is seeking participants, which began recruiting on March 1st 2021 and was last updated in December of the same year. A total of 100 patients are being recruited from one location."
Answered by AI
Is the enrollment process open for this investigation?
"As visible on clinicaltrials.gov, the recruitment for this medical trial is still active; it was initially published in March 2021 and its details were most recently modified December of that same year."
Answered by AI
Who else is applying?
What state do they live in?
Maryland
What site did they apply to?
Johns Hopkins University School of Medicine
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
For the money and to help science. I am dizzy, some memory loss, and I think I can be of value to you.
PatientReceived 1 prior treatment
What questions have other patients asked about this trial?
How much is compensation?
PatientReceived 2+ prior treatments
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