Clinical trial NCT06963879: Validation Study of a New Digital Diagnostic and Treatment Test Based on Interactive Video Games for Alzheimer's Disease
Official title: Validation Study of a New Digital Diagnostic and Treatment Test Based on Interactive Video Games for Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Alzheimer Disease
MCI
Lead sponsor: Braingaze
Sponsor class: INDUSTRY
First posted: 2025-05-09
Enrollment: 60
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Beta biomarkers
timeFrame: Immediately after the intervention
measure: PTau Biomarkers
timeFrame: Immediately after the intervention
measure: Pupil Response
timeFrame: Immediately after the intervention
measure: Ocular vergence
timeFrame: Immediately after the intervention
Secondary outcomes:
measure: Montreal Cognitive Assessment (MoCA) Score
timeFrame: Immediately after the intervention
Other outcomes:
Locations:
city: Mataró
country: Spain
facility: Braingaze
state: Barcelona
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.