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

NCT06963879 | Enrolling By Invitation

• 1 other identifier: PID2022-139968OB-I00
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Alzheimer Disease; MCI

Outcome Measures

Primary Outcomes (4)

• Beta biomarkers

  Measure changes in plasma ßA40 and ßA42 in pg/mL

  Immediately after the intervention

• PTau Biomarkers

  Measure changes in plasma PTau181 and pTau217 in pg/mL

  Immediately after the intervention

• Pupil Response

  Pupillary diameter in millimeters (mm) will be calculated from data obtained using eye-tracking devices.

  Immediately after the intervention

• Ocular vergence

  Ocular vergence in degrees (°) will be calculated from data obtained using eye-tracking devices.

  Immediately after the intervention

Secondary Outcomes (1)

• Montreal Cognitive Assessment (MoCA) Score

  Immediately after the intervention

Study Arms (2)

BGaze Therapy MCI

EXPERIMENTAL

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

Device: Bgaze Therapy; Diagnostic Test: Bgaze Attention Task

BGaze Therapy AD

EXPERIMENTAL

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

Device: Bgaze Therapy; Diagnostic Test: Bgaze Attention Task

Interventions

Bgaze Therapy DEVICE

BGaze Therapy is a digital intervention by Braingaze designed to enhance attention and memory in individuals with Alzheimer's Disease (AD) and Mild Cognitive Impairment (MCI). It uses an interactive video game controlled through eye-tracking, allowing users to play using only their gaze. The therapy is based on research linking eye vergence and pupil responses to cognitive processing-physiological markers that may indicate neurodegeneration. During gameplay, these responses are modulated, potentially inducing gamma brain oscillations associated with reduced AD pathology. Patients play at care-center for 5-10 minutes daily over two months. Equipment is provided, and both in-person and remote support ensure usability. The game adapts difficulty in real time and provides feedback to keep users engaged and stimulate cognitive function.

BGaze Therapy AD; BGaze Therapy MCI

Bgaze Attention Task DIAGNOSTIC_TEST

For the validation of diagnosis of AD with vergence method the Attention Test (B-Gaze) will be used. This is an odd ball paradigm where visual target has to be detected among blue distractors. The test consist of 100 trials of 1 second and last about 3 minutes. The task uses remote eye infra-red tracking to measure eye vergence. Subjects merely have to fixate at the computer screen during the task.

BGaze Therapy AD; BGaze Therapy MCI

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Braingaze: lead

Study Sites (1)

Braingaze

Mataró, Barcelona, 08302, Spain

Location

Related Publications (3)

• Romeo A, Leonovych O, Sole Puig M, Super H. Cognitive Vergence Recorded with a Webcam-Based Eye-Tracker during an Oddball Task in an Elderly Population. Sensors (Basel). 2024 Jan 30;24(3):888. doi: 10.3390/s24030888.

  PMID: 38339605 BACKGROUND

• Jimenez EC, Sierra-Marcos A, Romeo A, Hashemi A, Leonovych O, Bustos Valenzuela P, Sole Puig M, Super H. Altered Vergence Eye Movements and Pupil Response of Patients with Alzheimer's Disease and Mild Cognitive Impairment During an Oddball Task. J Alzheimers Dis. 2021;82(1):421-433. doi: 10.3233/JAD-201301.

  PMID: 34024820 BACKGROUND

• Hashemi A, Leonovych O, Jiménez EC, Sierra-Marcos A, Romeo A, Valenzuala PB, et al. Classification of MCI patients using vergence eye movements and pupil responses obtained during a visual oddball test. Aging Health Res. 2023 Mar 1;3(1):100121.

  BACKGROUND

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 22, 2025
• First Posted: May 9, 2025
• Study Start: May 1, 2025
• Primary Completion: November 30, 2025
• Study Completion: December 31, 2025
• Last Updated: May 9, 2025

Record last verified: 2025-04

Locations

ES (1)