Tokyo, Oct. 7 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063187) titled 'A Study to Evaluate the Equivalence Between the Self-Administered Digital Cognitive Assessment Tool MoCA Solo-J and Its Paper-Based Version, MoCA-J' on Oct. 6.
Study Type:
Observational
Primary Sponsor:
Institute - Oita University Faculty of Medicine
Condition:
Condition - To verify the equivalence between the paper-and-pencil cognitive assessment tool MoCA-J (Japanese version of the Montreal Cognitive Assessment) and MoCA Solo-J, a fully self-administered digital cognitive assessment tool (Japanese version of MoCA Solo).
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To verify the equivalence between the paper-and-pencil cognitive assessment tool MoCA-J (Japanese version of the Montreal Cognitive Assessment) and MoCA Solo-J, a fully self-administered digital cognitive assessment tool (Japanese version of MoCA Solo).
Basic objectives2 - Others
Eligibility:
Age-lower limit - 40
years-old
Gender - Male and Female
Key inclusion criteria - Patients visiting the Department of Neurology, Oita University Hospital, who meet all of the following criteria:
1) Patients with subjective or objective cognitive complaints (selected at the discretion of the physician)
2) Patients aged 40 years or older and 90 years or younger at the time of consent
3) Native Japanese speakers
4) Patients who are able to understand the explanation of the study and provide written informed consent by themselves
Key exclusion criteria - Patients who meet any of the following criteria are excluded:
1) Patients newly prescribed anti-dementia drugs within the past 6 months (patients on long-term anti-dementia drug treatment with stable symptoms are eligible)
2) Patients whose anti-dementia medication was started or changed within the past 1 month
3) Patients with severe cognitive impairment
4) Patients with severe psychiatric disorders (such as schizophrenia or bipolar disorder)
5) Patients with alcohol or drug dependence
6) Patients with a history of serious head trauma
7) Patients with marked visual or hearing impairment
8) Patients with a physical disability that makes the use of a tablet device markedly difficult
9) Patients with suspected dementia with Lewy bodies (due to large fluctuations in cognitive function)
10) Patients judged to be inappropriate as study participants by the investigators for any other reason
Target Size - 50
Recruitment Status:
Recruitment status - No longer recruiting
Date of protocol fixation - 2025 Year 12 Month 08 Day
Date of IRB - 2026 Year 01 Month 28 Day
Anticipated trial start date - 2026 Year 03 Month 02 Day
Last follow-up date - 2026 Year 09 Month 30 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071887
Disclaimer: Curated by HT Syndication.
