Tests a video game with eye tracking for Alzheimer's disease and MCI
Tests an eye-tracking video game for attention and memory in people with memory decline.
Plain-language title generated from the registry record
Registry title: Validation Study of a New Digital Diagnostic and Treatment Test Based on Interactive Video Games for Alzheimer's Disease
Key facts
- Where
- Mataró, SpainSee the site
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for people aged 50 or older with early-stage Alzheimer's disease or mild cognitive impairment. It tests an eye-tracking video game for diagnosis and training.
- Age
- 50 years or older
- Sex
- All sexes can join
- Disease stage
- Early-stage Alzheimer's disease (AD) or mild cognitive impairment (MCI), diagnosed by a doctor using National Institute on Aging-Alzheimer's Association criteria
Main reasons for not taking part
- Severe cognitive impairment (MMSE below 10)
- Neurological conditions that affect thinking, for example stroke
- Severe psychiatric disorders
- Brain structure problems, such as tumors, that affect thinking
- Significant vision problems
Read by machine on 9 November 2026.
Where in Spain
- BraingazeMataró, SpainNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Braingaze
- Trial code
- NCT06963879
- Record updated
- 9 May 2025
- Original description
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.Read full original descriptionShow less
Validation Study of a New Digital Diagnostic and Treatment Test Based on Interactive Video Games for Alzheimer's Disease
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.
Inclusion: 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: 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.