AzTrials
AzTrials

Alzheimer DiseaseEyeADNCT06963879

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

A study testing Bgaze Therapy and Bgaze Attention Task in people with Alzheimer Disease and MCI, run by Braingaze at 1 site in Spain.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Alzheimer Disease, MCI
What is being tested?
Bgaze Therapy and Bgaze Attention Task
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteSpain
Study dates
1 May 2025to 31 Dec 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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 locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Spain1 site

  • Braingaze

    Mataró, Barcelona, 08302

Other trials in Spain

About this study

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.

Read more

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.

Being tested
Bgaze Therapy, Bgaze Attention Task
Medical subject headings
Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bgaze TherapyDevice

    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 Attention TaskDiagnostic 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.

Study groups in NCT06963879
Study groupRoleWhat they receive
BGaze Therapy MCIExperimental30 Patients with Mild Cognitive Impairment for validation and 15 for therapy
Receives: Device: Bgaze Therapy; Diagnostic Test: Bgaze Attention Task
BGaze Therapy ADExperimental30 Patients with Early Alzheimer's Disease for validation and 15 for therapy
Receives: Device: Bgaze Therapy; Diagnostic Test: Bgaze Attention Task

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Beta biomarkers

    Measure changes in plasma ßA40 and ßA42 in pg/mL

    Measured: Immediately after the intervention

  2. PTau Biomarkers

    Measure changes in plasma PTau181 and pTau217 in pg/mL

    Measured: Immediately after the intervention

  3. Pupil Response

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

    Measured: Immediately after the intervention

  4. Ocular vergence

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

    Measured: Immediately after the intervention

Secondary outcomes (1)

  1. Montreal Cognitive Assessment (MoCA) Score

    Score in the Montreal Cognitive Assessment (MoCA); units on a scale (0-30), with higher scores indicating better cognitive function.

    Measured: Immediately after the intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 May 2025
  2. Study start1 May 2025 (estimated)
  3. Primary completion30 Nov 2025 (estimated)
  4. Study completion31 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06963879
Sponsor's protocol ID
PID2022-139968OB-I00
Acronym
EyeAD
Status last verified
Apr 2025
First submitted
22 Apr 2025
Last updated
9 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 38339605

  • 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.

    PubMed 34024820

  • 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.

Questions about this trial

What is this clinical trial studying?

A study testing Bgaze Therapy and Bgaze Attention Task in people with Alzheimer Disease and MCI, run by Braingaze at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 9 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Beta biomarkers (time frame: Immediately after the intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06963879, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in