A validation study of the voice-based cognitive assessment program

JRCT ID: jRCT2042240074

Registered date:20/08/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Healthy adults, Suspected cognitive decline.Picking up undiagnosed or untreated patients at fam
• Date of first enrollment: 20/08/2024
• Target sample size: 99
• Study type: Interventional
• Intervention(s): Using this device, cognitive function tests and psychological tests (MoCA-j, CDR, MMSE-J) will be conducted by recording spoken voice, and the test results will be compared.

Outcome(s)

• Primary Outcome: To evaluate the MoCA-J score, sensitivity and specificity of this device for definitive diagnosis results
• Secondary Outcome: The correlation between the test results of this device and the CDR Global Score and MMSE-J score will be evaluated.

Key inclusion & exclusion criteria

• Age minimum: >= 50age old
• Age maximum: < 90age old
• Gender: Both

Include criteria

1. Subjects aged 50 to 90 years old who meet the following criteria (1), (2), or (3).
(1)Dementia (already diagnosed)
(2) Suspected cognitive decline
(3) Healthy adults
2.Able to take a medical interview (conversation with a doctor or medical professional).
3. Able to be accompanied by a co-participant (study partner) who can answer the CDR.
4.Who can obtain written consent from the person or his / her substitute or study partner.

Exclude criteria

1.Those who have been judged by a doctor to have difficulty speaking normally.
2. Who has been diagnosis with a psychiatric disorder such as depression.
3. Meets any of the following criteria (1), (2), or (3).
(1)Dementia (diagnosed)
Who has undergone neuropsychological examination within last 3 months.
(2)Suspected cognitive decline
Who has undergone neuropsychological examination within last 6 months.
(3)Healthy adult
Who has undergone neuropsychological examination within last 6 months.
4.Who has been judged by a doctor that suspected to have a sevier respiratory disease.
5.Who has confirmed participate of development of this AI system.
6.Who has been judged by a doctor not to be suitable for this study by any reasons.

Related Information

• Primary Sponsor: Tobita kimimasa
• Source(s) of Monetary Support: SEKISUI CHEMICAL CO., LTD