Tokyo, Sept. 3 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062771) titled 'Study of developing an early detection and prevention tool for amyloid beta accumulation in the brain using biosensors' on Sept. 3.
Study Type:
Observational
Primary Sponsor:
Institute - Oita University Faculty of Medicine
Condition:
Condition - mild cognitive impairment and subjective cognitive decline
Classification by malignancy - Others
Genomic information - YES
Objective:
Narrative objectives1 - The objective of this study is to establish an assessment algorithm for predicting and stratifying the risk of amyloid beta accumulation in the brain without requiring PET, and an implementation model that can be integrated into municipal dementia prevention programs.
Basic objectives2 - Others
Eligibility:
Age-lower limit - 50
years-old
Gender - Male and Female
Key inclusion criteria - 1.Subject who lives in Beppu City, Oita Prefecture
2.Men and women who are between 50 and 89 years of age at the time of obtaining informed consent
3.To be physically and mentally healthy
4.Not diagnosed with dementia
5.Independent in activities of daily living
6.Willing and able to complete the protocol
7.Clinical Dementia Rating (CDR) score of 0 or 0.5
Key exclusion criteria - 1.Any significant neurological, psychiatric, or neurodegenerative disease or substance dependence, or a history thereof, that may cause cognitive decline unrelated to Alzheimer's disease
2.3.History of significant alcohol or substance abuse
4.5.Clinically significant and severe abnormalities in hepatic and/or renal function
6.Subjects who participate in another study within 3 months
7.Subjects who donated blood (over 200ml or over 400ml, within 1 month or 3 months, respectively
8.Subjects who are judged to be inadequate for their eligibility by investigators
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 - 2031 Year 02 Month 28 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071825
Disclaimer: Curated by HT Syndication.
