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Validation Study of a New Digital Treatment Test

Primary Purpose

Alzheimer Disease, MCI

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
BGaze therapy Alzheimer
Sponsored by
Braingaze
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer Disease

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • BraingazeRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment

Arm Description

Outcomes

Primary Outcome Measures

MoCA
Measure changes in MoCA
MMSE
Measure changes in MMSE

Secondary Outcome Measures

CANTAB
Measure changes in CANTAB tests

Full Information

First Posted
May 13, 2021
Last Updated
May 18, 2021
Sponsor
Braingaze
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1. Study Identification

Unique Protocol Identification Number
NCT04897464
Brief Title
Validation Study of a New Digital Treatment Test
Official Title
Validation Study of a New Digital Treatment Test Based on Interactive Video Games for Alzheimer's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2021 (Anticipated)
Primary Completion Date
March 31, 2022 (Anticipated)
Study Completion Date
May 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Braingaze

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease, MCI

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
BGaze therapy Alzheimer
Intervention Description
BGaze Therapy is an interactive eye tracking game
Primary Outcome Measure Information:
Title
MoCA
Description
Measure changes in MoCA
Time Frame
immediately after the intervention
Title
MMSE
Description
Measure changes in MMSE
Time Frame
immediately after the intervention
Secondary Outcome Measure Information:
Title
CANTAB
Description
Measure changes in CANTAB tests
Time Frame
immediately after the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 1) Clinical diagnosis of MCI or AD Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hans Super
Phone
0034931696572
Email
hans@braingaze.eu
First Name & Middle Initial & Last Name or Official Title & Degree
Laszlo Bax
Phone
0034931696572
Email
Laszlo@braingaze.eu
Facility Information:
Facility Name
Braingaze
City
Mataró
State/Province
Barcelona
ZIP/Postal Code
08302
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hans Super
Email
hans@braingaze.eu

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
anonymized data can be shared upon request

Learn more about this trial

Validation Study of a New Digital Treatment Test

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