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Behavioural Intervention

VR Audiovisual Stimulation for Alzheimer's Disease (CFS Trial)

N/A

Recruiting

Led By Carolina Reis, PhD

Research Sponsored by Clarity Health Technologies, Inc

Eligibility Criteria Checklist

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

Must have

Mild AD Participants: A diagnosis of mild Alzheimer's disease

Mild AD Participants: Normal or corrected to normal vision

Must not have

Mild AD Participants: Impaired visual and/or auditory acuity that is not corrected

Mild AD Participants: Clinically significant medical disorder, condition, disease or clinically significant finding at screening that precludes participant's participation in study activities

Timeline

Screening 3 weeks

Treatment Varies

Follow Up immediately after the intervention

Awards & highlights

No Placebo-Only Group

Summary

This trial will test whether it is safe and comfortable to use Virtual Reality headsets to provide audiovisual stimulation to people with mild Alzheimer's disease and healthy individuals of the same age.

Who is the study for?

This trial is for individuals with mild Alzheimer's disease and healthy older adults. Specific criteria aren't provided, but typically participants must meet certain health standards and not have conditions that could interfere with the study or pose a risk.

What is being tested?

The study tests if it's safe and feasible to use a VR headset to provide audiovisual stimulation to people with mild Alzheimer's and healthy aging individuals. It’s single-blind, meaning only the participants won’t know if they’re getting the real treatment or a sham (fake) version.

What are the potential side effects?

Since this trial focuses on safety and tolerability, potential side effects might include discomfort from wearing the VR headset, dizziness, nausea, eye strain or emotional reactions to the stimuli.

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 Alzheimer's disease.

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My vision is normal or corrected to normal.

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I am between 50 and 90 years old and have no cognitive impairments.

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I have mild Alzheimer's and my hearing is normal.

Exclusion Criteria

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

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I have vision or hearing problems that glasses or hearing aids can't fix.

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I do not have any health issues that would stop me from joining the study.

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I have had a stroke but am cognitively normal.

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I am on a stable dose of medication for memory problems.

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I or my family have no history of seizures or epilepsy.

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I have a history of narrow-angle glaucoma.

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I have had a stroke in the past.

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I or my family have a history of seizures or epilepsy.

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I have a history of narrow angle glaucoma.

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I have a neurological condition other than dementia.

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I have been diagnosed with Alzheimer's or a similar dementia but am still cognitively normal.

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I do not have any health issues that would stop me from joining the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ immediately after the intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~immediately after the intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and immediately after the intervention for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Changes in brain activity associated with exposure to VR-based audiovisual stimulation

Incidence of Stimulation-Emergent Adverse Events

Level of tolerance to VR-based sensory stimulation exposure

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

Group I: Active and Sham Audiovisual Stimulation (Mild AD and MCI due to AD):Experimental Treatment1 Intervention

Both active and sham stimulation conditions will be delivered to 25 cognitively impaired participants to demonstrate the mechanism of action of the intervention.

Group II: Active and Sham Audiovisual Stimulation (Cognitively Healthy):Experimental Treatment1 Intervention

Both active and sham stimulation conditions will be delivered to 25 healthy participants to demonstrate the mechanism of action of the intervention.

0 / 16Eligibility criteria met