Study on utility of a cognitive function test program

JRCT ID: jRCTs042200006

Registered date:27/04/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Alzheimer's disease, mild cognitive impairment
• Date of first enrollment: 28/08/2020
• Target sample size: 60
• Study type: Interventional
• Intervention(s): effort and time for manupilation of a tablet

Outcome(s)

• Primary Outcome: - Accuracy and response time at each task of A-003

Secondary Outcome

- Total time for completion of A-003
- Comparison and correlation of each task of A-003 with neurophycological tests
- Discrimination ability of A-003 among groups (sensitivity/specificity, AUC of ROC curve)

Key inclusion & exclusion criteria

• Age minimum: >= 55age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Subjects who sign an informed consent
2. subjects who can manipulate a tablet
3. outpatient and medication are not asked.
4. A statistically significant difference is not observed in terms of things like an age between groups.
(1) Alzheimers disease
- Subjects who are diagnosed with diagnostic guidelines for Alzheimers disease from the National Institute on Aging-Alzheimers Association workgroups where assessment for decline of cognitive function is carried out with the ADNI criteria.
- Subjects who are certainly diagnosed after first visit.
(2) mild cognitive impairment
- Subjects who are diagnosed with diagnostic guidelines mild cognitive impairment due to Alzheimers disease from the National Institute on Aging-Alzheimers Association workgroups where assessment for decline of cognitive function is carried out with the ADNI criteria.
- Subjects who are certainly diagnosed after first visit.
(3) healthy volunteer
- Subjects who are finally diagnosed to be healthy after assessment.
- Subjects who accompany outpatients.

Exclude criteria

- Subjects with psychiatric disorders like major depression disorder, bipolar disorder, epilepsy or schizophrenia
- Subjects who may have epilepsy or photosensitivity by light stimulation
- Subjects who are judged to be unacceptable by medical doctors

Related Information

• Primary Sponsor: Takechi Hajime
• Secondary Sponsor: Life Science Institute Inc.