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Validation Study of a New Digital Treatment Test

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04897464
Recruitment Status : Recruiting
First Posted : May 21, 2021
Last Update Posted : May 21, 2021
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Alzheimer Disease MCI Other: BGaze therapy Alzheimer Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Validation Study of a New Digital Treatment Test Based on Interactive Video Games for Alzheimer's Disease
Estimated Study Start Date : June 1, 2021
Estimated Primary Completion Date : March 31, 2022
Estimated Study Completion Date : May 31, 2022

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Treatment Other: BGaze therapy Alzheimer
BGaze Therapy is an interactive eye tracking game

Primary Outcome Measures :
  1. MoCA [ Time Frame: immediately after the intervention ]
    Measure changes in MoCA

  2. MMSE [ Time Frame: immediately after the intervention ]
    Measure changes in MMSE

Secondary Outcome Measures :
  1. CANTAB [ Time Frame: immediately after the intervention ]
    Measure changes in CANTAB tests

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04897464

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Contact: Hans Super 0034931696572
Contact: Laszlo Bax 0034931696572

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Braingaze Recruiting
Mataró, Barcelona, Spain, 08302
Contact: Hans Super   
Sponsors and Collaborators
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Responsible Party: Braingaze Identifier: NCT04897464    
Other Study ID Numbers: BT-AD-01
First Posted: May 21, 2021    Key Record Dates
Last Update Posted: May 21, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: anonymized data can be shared upon request

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders