Tokyo, Jan. 21 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060413) titled 'Biopsychosocial factors associated with treatment decision-making for anti-amyloid beta antibody therapy in early Alzheimer's disease: a multicenter prospective observational study' on Jan. 20.

Study Type: Observational

Primary Sponsor: Institute - St. Marianna University School of Medicine

Condition: Condition - Early Alzheimer's disease (MCI due to AD / mild AD dementia) Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To clarify biopsychosocial factors associated with treatment decision-making in patients initiating anti-amyloid beta antibody therapy (lecanemab or donanemab), and to examine longitudinal changes in decision-making capacity over 18 months. Basic objectives2 - Others

Eligibility: Age-lower limit - 50 years-old = Gender - Male and Female Key inclusion criteria - Patients clinically diagnosed with probable Alzheimer's disease dementia or MCI due to Alzheimer's disease at participating institutions between the ethics approval date and March 31, 2027.

Patients who underwent amyloid PET and were confirmed positive.

Patients for whom intravenous treatment with lecanemab or donanemab has been determined to be appropriate by the attending physician.

Patients who have provided written informed consent, either directly or via a legally authorized representative.

Age between 50 and 90 years. Key exclusion criteria - - Patients whose amyloid PET result was negative at the baseline evaluation - Patients diagnosed with mild cognitive impairment or dementia due to other neurodegenerative diseases or medical conditions - Patients deemed unsuitable for participation in this study by the attending physician Target Size - 50

Recruitment Status: Recruitment status - Enrolling by invitation Date of protocol fixation - 2025 Year 11 Month 25 Day Date of IRB - 2025 Year 11 Month 25 Day Anticipated trial start date - 2026 Year 01 Month 21 Day Last follow-up date - 2029 Year 12 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069110

Disclaimer: Curated by HT Syndication.