NCT04897464

Brief Summary

Oculomotor behavior and cognitive processing of visual information are intimately connected. AD patients show ocular movement problems. Oculomotor deficits are broad consisting mainly of different saccade metrics, altered pupil responses. and smaller and irregular eye vergence movements. Here we test an interactive eye-tracking game to improve eye motion control and thereby training cognitive behavior

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable alzheimer-disease

Timeline
Completed

Started Jun 2021

Shorter than P25 for not_applicable alzheimer-disease

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 13, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 21, 2021

Completed
11 days until next milestone

Study Start

First participant enrolled

June 1, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2022

Completed
Last Updated

May 21, 2021

Status Verified

May 1, 2021

Enrollment Period

10 months

First QC Date

May 13, 2021

Last Update Submit

May 18, 2021

Conditions

Alzheimer DiseaseMCI

Outcome Measures

Primary Outcomes (2)

  • MoCA

    Measure changes in MoCA

    immediately after the intervention

  • MMSE

    Measure changes in MMSE

    immediately after the intervention

Secondary Outcomes (1)

  • CANTAB

    immediately after the intervention

Study Arms (1)

Treatment

EXPERIMENTAL
Other: BGaze therapy Alzheimer

Interventions

BGaze therapy AlzheimerOTHER

BGaze Therapy is an interactive eye tracking game

Treatment

Eligibility Criteria

Age50 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \) Clinical diagnosis of MCI or AD

You may not qualify if:

  • Severe cognitive deterioration
  • History of neurological disease with clinically relevant impact on cognition
  • Severe psychiatric disorder
  • Incidental structural brain findings with impact on cognitive impairment
  • Presence of relevant visual problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Braingaze

Mataró, Barcelona, 08302, Spain

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Central Study Contacts

Hans Super

CONTACT

0034931696572hans@braingaze.eu

Laszlo Bax

CONTACT

0034931696572Laszlo@braingaze.eu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 13, 2021

First Posted

May 21, 2021

Study Start

June 1, 2021

Primary Completion

March 31, 2022

Study Completion

May 31, 2022

Last Updated

May 21, 2021

Record last verified: 2021-05

Locations

ES(1)