Validation Study of a New Digital Treatment Test

• Sponsor: Braingaze (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT04897464
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 12
• Patients Per Site Per Month: 5

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Alzheimer Disease; MCI	Other: BGaze therapy Alzheimer	N/A

Study Design

• Study Type: Interventional
• Anticipated 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
• Anticipated Study Start Date: Jun 1, 2021
• Anticipated Primary Completion Date: Mar 31, 2022
• Anticipated Study Completion Date: May 31, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. MoCA [immediately after the intervention]

   Measure changes in MoCA

2. MMSE [immediately after the intervention]

   Measure changes in MMSE

Secondary Outcome Measures

1. CANTAB [immediately after the intervention]

   Measure changes in CANTAB tests

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years to 85 Years
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Braingaze	Mataró	Barcelona	Spain	08302

Sponsors and Collaborators

• Braingaze

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Braingaze
• ClinicalTrials.gov Identifier: NCT04897464
• Other Study ID Numbers: BT-AD-01
• First Posted: May 21, 2021
• Last Update Posted: May 21, 2021
• Last Verified: May 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Alzheimer Disease

Study Results

No Results Posted as of May 21, 2021