A validation study of the cognitive assessment program

JRCT ID: jRCT2052210004

Registered date:09/04/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: cognitively healthy subjects and subjects with dementia or mild cognitive impairment (MCI)
• Date of first enrollment: 06/04/2021
• Target sample size: 75
• Study type: Interventional
• Intervention(s): All subjects will be performed for cognitive function with MMSE and investigational device.

Outcome(s)

• Primary Outcome: A correlation of total cognitive scores between the clinical trial equipment and MMSE

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

The inclusion criteria on this study is as follows;

1. Participants who sign the consent document by their own decision. The consent can be obtained by proxies when the participants with dementia have substiantial impairments in their abilities to understand.
If those with dementia seem to be able to comprehend the information provided, the consent needs to be obtained from both the participant and his/her proxy.

2. Participants without current or past diagnosis of neurological or mental diseases.

Exclude criteria

The exclusion criteria on this study is as follows;

1. Participants with ophthalmic diseases such as strabismus, cataract, glaucoma and diabetic retionopathy. These diseases have a possibility to affect the gaze detection and tracking system because of weakened eyesight and partial visual field defect. Participants are asked to take off their glasses prior to the eye-tracking calibration, if they're wearing the following types of glasses to correct visual acuity.
1) dark shades sunglasses which make it impossible for the eye-tracking system to capture a clear view of the eyes
2) glasses with small frame or thick frame
3) glasses with high lens power for myopia of -6.25 diopters or more
4) glasses of +13 diopters or more for people who had surgical removal of the crystalline lens
5) multifocal lens glasses whose lower section consists of convex lens of short focal length

2. Participants who can't complete MMSE because they have neurological diseases with movement disorders or difficulties in hearing

3. Participants who took the eye-tracking based cognitive assessment used in this study or MMSE within the past three months prior to the enrollment date

4. Participants who are considered not to be eligible for this study by the study responsible physician. For example, participants with eye movement or alignment abnormalities because of nystagmus or trauma. Also, participants who can't maintain sitting posture during cognitibe assessments are excluded.

5. Participants taking part in other stydies, or those are going to participate in other studies by when they take the eye-tracking based cognitive assessment used in this study

Related Information

• Primary Sponsor: Kitajima Manabu