Tokyo, Oct. 7 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063185) titled 'Stratified Testing for Risk Identification using Digital and Blood Evaluations in Prodromal Alzheimer's Disease' on Oct. 6.
Study Type:
Observational
Primary Sponsor:
Institute - Oita University Faculty of Medicine
Condition:
Condition - Mild cognitive impairment and mild dementia due to Alzheimer's disease
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - This study tests whether a stepwise (hierarchical) diagnostic pathway that combines a self-administered digital cognitive assessment (MoCA Solo-J) performed in primary care with an Alzheimer's disease blood biomarker (plasma pTau217/Abeta42) reduces the false-positive rate for identifying mild cognitive impairment (MCI) and mild dementia due to Alzheimer's disease, compared with the blood biomarker alone. Eight hundred community-dwelling residents aged 50 to 89 years in Beppu City, Oita, Japan undergo XpressO screening at a community health check-up, MoCA Solo-J at their primary care physician's office, and plasma pTau217/Abeta42 measurement. Using specialist assessment including CDR and amyloid PET as the reference standard, the diagnostic performance (accuracy, PPV, NPV, sensitivity, and specificity) of four diagnostic strategies is compared: (A) usual primary care practice, (B) digital cognitive assessment alone, (C) blood biomarker alone, and (D) the hierarchical diagnostic pathway. Secondary objectives are to estimate an appropriate plasma pTau217/Abeta42 cutoff value in a Japanese community-dwelling cohort and to evaluate the utility of MoCA Solo-J in routine primary care.
Basic objectives2 - Others
Eligibility:
Age-lower limit - 50
years-old
Gender - Male and Female
Key inclusion criteria - All of the following must be met:
(1) Resident of Beppu City, Oita Prefecture, Japan
(2) Aged 50 years or older and under 90 years at the time of consent (either sex)
(3) Physically and mentally healthy
(4) No diagnosis of dementia
(5) Independent in activities of daily living
(6) Able to understand and comply with the study requirements
(7) Clinical Dementia Rating (CDR) of 0 or 0.5
Key exclusion criteria - Any of the following:
(1) Psychiatric disorder, neurodegenerative disease, or drug dependence, or a history thereof, considered to be a cause of cognitive decline other than Alzheimer's disease
(2) Alcohol dependence or a history thereof
(3) Drug dependence or a history thereof
(4) Severe hepatic impairment
(5) Severe renal impairment, including patients on haemodialysis
(6) Participation in a clinical trial or other clinical study within 3 months before enrolment
(7) Blood donation or other blood sampling of 200 mL or more within 1 month, or 400 mL or more within 3 months, before enrolment
(8) Any other condition that, in the judgement of the investigator, makes the person unsuitable as a participant
Target Size - 800
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 05 Month 08 Day
Date of IRB - 2026 Year 06 Month 23 Day
Anticipated trial start date - 2026 Year 09 Month 06 Day
Last follow-up date - 2028 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071848
Disclaimer: Curated by HT Syndication.
