Validation Study of a New Digital Diagnostic and Treatment Test Based on Interactive Video Games for Alzheimer's Disease (EyeAD)

Braingaze

Status: Invitation-only

Conditions: MCI; Alzheimer Disease

Treatments: Diagnostic Test: Bgaze Attention Task; Device: Bgaze Therapy

Study type: Interventional

Funder types: Industry

Identifiers

NCT06963879

PID2022-139968OB-I00

Details and patient eligibility

About

This study aims to validate a novel, non-invasive diagnostic and digital therapeutic approach for Alzheimer's Disease (AD), centered on an interactive video game called BGaze Therapy. This platform leverages eye-tracking technology to assess and potentially enhance cognitive functions, particularly attention and memory.

The diagnostic component of the study investigates the use of eye vergence responses-elicited during a visual attention task-as potential biomarkers for early AD. Specifically, the study will re-validate eye vergence by comparing response patterns among three groups: cognitively healthy older adults, individuals with Mild Cognitive Impairment (MCI), and patients with confirmed AD, based on blood biomarkers (ßA40, ßA42, pTau181, and pTau217). The diagnostic task follows an oddball paradigm, where participants must detect target images (grapes) among distractors (other fruits) across 100 one-second trials, lasting approximately three minutes. Eye vergence is recorded using remote infrared eye-tracking, while participants simply fixate on a computer screen.

The therapeutic aspect evaluates the impact of BGaze Therapy, which employs "serious games" designed to train attentional control through eye movements. The game dynamically adjusts its difficulty in real time and provides continuous feedback to enhance user engagement and learning efficacy.

Participants will undergo pre-testing-including blood biomarker analysis and standardized cognitive assessments (MMSE and MoCA)-followed by a two-month training phase at care centers using the BGaze Therapy system. Post-intervention testing will mirror the pre-test protocol to assess cognitive and neurological changes.

A total of 60 participants (30 with MCI and 30 with AD) will be recruited for the validation phase. A subsample (15 MCI and 15 AD participants) will be selected for the treatment phase.

Ultimately, this study aims to establish BGaze as a cost-effective, scalable, and non-invasive tool for the early diagnosis and treatment of Alzheimer's Disease by addressing the attentional and cognitive deficits associated with the condition.

Enrollment: 60 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Aged 50 years or older.
• Clinical diagnosis of early-stage AD or MCI based the criteria of National Institute on Aging-Alzheimer's Association.
• Capable of providing informed consent.

Exclusion criteria

• Severe cognitive impairment (MMSE < 10).
• Neurological conditions affecting cognition (e.g., stroke).
• Severe psychiatric disorders.
• Structural brain abnormalities (e.g., tumors) with cognitive impact.
• Significant visual impairments.
• Inability to understand or communicate in Spanish.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

BGaze Therapy MCI

Experimental group

Description:

30 Patients with Mild Cognitive Impairment for validation and 15 for therapy

Treatment:

Device: Bgaze Therapy

Diagnostic Test: Bgaze Attention Task

BGaze Therapy AD

Experimental group

Description:

30 Patients with Early Alzheimer's Disease for validation and 15 for therapy

Treatment:

Device: Bgaze Therapy

Diagnostic Test: Bgaze Attention Task