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NCT04897464 Clinical Trial

Validation Study of a New Digital Treatment Test

Alzheimer Disease Clinical Trial

Official title:
Validation Study of a New Digital Treatment Test Based on Interactive Video Games for Alzheimer's Disease

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04897464
Other study ID # BT-AD-01
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 1, 2021
Est. completion date May 31, 2022

Study information
Verified date May 2021
Source Braingaze
Contact Hans Super
Phone 0034931696572
Email hans@braingaze.eu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Recruiting
Enrollment 60
Est. completion date May 31, 2022
Est. primary completion date March 31, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 50 Years to 85 Years
Eligibility Inclusion Criteria: 1) Clinical diagnosis of MCI or AD Exclusion Criteria: 1. Severe cognitive deterioration 2. History of neurological disease with clinically relevant impact on cognition 3. Severe psychiatric disorder 4. Incidental structural brain findings with impact on cognitive impairment 5. Presence of relevant visual problems

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• BGaze therapy Alzheimer
BGaze Therapy is an interactive eye tracking game

Locations
Country Name City State
Spain Braingaze Mataró Barcelona

Sponsors (1)
Lead Sponsor Collaborator
Braingaze

Country where clinical trial is conducted

Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary MoCA Measure changes in MoCA immediately after the intervention
Primary MMSE Measure changes in MMSE immediately after the intervention
Secondary CANTAB Measure changes in CANTAB tests immediately after the intervention
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