Using Virtual Reality for Audiovisual Stimulation in Alzheimer's and Healthy Aging

The Feasibility, Safety and Tolerability of Virtual Reality-based Audiovisual Stimulation

This study is testing whether using virtual reality with light and sound can safely help people with mild Alzheimer's and healthy older adults feel better and improve brain activity.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 50 Years to 90 Years
• Sex: All
• Sponsor: Clarity Health Technologies, Inc (Industry-sponsored)
• Drugs / interventions: Lecanemab, Aducanumab
• Locations: 2 sites (Portola Valley, California and 1 other locations)
• Trial ID: NCT06234930 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety, tolerability, and feasibility of delivering audiovisual stimulation through a Virtual Reality (VR) headset to individuals with mild Alzheimer's disease and cognitively healthy participants. The study involves a single-blind, sham-controlled design where participants will experience synchronized light and sound stimuli aimed at modulating neural activity. A total of 50 participants will be recruited, with assessments of brain activity using electroencephalography (EEG) and safety evaluated through questionnaires. The goal is to explore a non-invasive therapy for early-stage Alzheimer's disease and assess the practicality of VR technology in this context.

Who should consider this trial

Good fit: Ideal candidates include individuals aged 50-90 with mild Alzheimer's disease or mild cognitive impairment due to Alzheimer's, as well as cognitively healthy individuals within the same age range.

Not a fit: Patients with severe cognitive impairment or those outside the specified age range may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a novel non-invasive therapy to slow the progression of Alzheimer's disease.

How similar studies have performed: While the use of audiovisual stimulation is gaining interest, this specific application of VR technology in this context is relatively novel and has not been extensively tested in prior studies.

Eligibility criteria

Inclusion Criteria Mild AD/ MCI due to AD Participants:

* Age between 50 - 90 years old.
* A clinical diagnosis of Mild Cognitive Impairment due to Alzheimer's disease (confirmed by PET scan or CSF biomarkers) or Mild Alzheimer's disease
* MoCA score of 18-25.
* Willingness to sign informed consent document (if deemed to not have the capacity to sign the informed consent, a legally authorized representative will be asked to provide surrogate consent).
* Sufficient visual and hearing ability.
* Formal education of 8 or more years.
* Native English speakers or demonstrated fluency in English (participant; and LAR as needed)

Inclusion Criteria Cognitively Healthy Participants:

* Age between 50 - 90 years old.
* A MoCA score above or equal to 26.
* Willingness to sign informed consent document.
* Sufficient visual and hearing ability.
* Formal education of 8 or more years.
* Native English speakers or demonstrated fluency in English (participant)

Exclusion Criteria Mild AD/ MCI due to AD Participants:

* Previous exposure to monoclonal antibody medication (e.g., Lecanemab, Aducanumab).
* Active treatment with Memantine within the past 30 days.
* Initiation of acetylcholinesterase inhibitors within the past 30 days.
* A history of seizure or epilepsy including family history of seizure or epilepsy.
* A history of stroke.
* A diagnosis of migraine headache.
* History of alcohol use disorder within the past 2 years (DSM-V criteria).
* Current or past history of any neurological disorder other than dementia.
* Use of hearing aid device(s).
* Any known blood pathogens or disorders.
* Has any clinically significant medical disorder, condition, disease or clinically significant finding at screening that precludes participant's participation in study activities.
* Pregnancy (Verbal confirmation).
* Geriatric Depression Scale (GDS) \>8

Exclusion Criteria Cognitively Healthy Participants:

* Active treatment with Memantine within the past 30 days.
* Initiation of treatment with acetylcholinesterase inhibitors (e.g., donepezil, rivastigmine and galantamine) within the past 30 days.
* A history of seizure or epilepsy including family history of seizure or epilepsy.
* A history of stroke.
* A diagnosis of migraine headache.
* History of alcohol use disorder within the past 2 years (DSM-V criteria).
* Use of hearing aid device(s).
* Any known blood pathogens or disorders.
* A diagnosis of Alzheimer's disease and related dementias.
* Has any clinically significant medical disorder, condition, disease or clinically significant finding at screening that precludes participant's participation in study activities.
* Pregnancy (Verbal confirmation)
* Geriatric Depression Scale (GDS) \>8

Where this trial is running

Portola Valley, California and 1 other locations

• The Sequoias Portola Valley — Portola Valley, California, United States (Suspended)
• Lakeview Institute of Clinical Research LLC — Leesburg, Florida, United States (Recruiting)

Study contacts

• Principal investigator: Carolina Reis, PhD — Clarity Health Technologies
• Study coordinator: Sergi Navarro, MS

Conditions Healthy Aging; Alzheimer's Disease; Sensory neurostimulation; Non-invasive neuromodulation; AD; Healthy; 50-90 years old; Gamma sensory stimulation