Tokyo, July 10 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062108) titled 'Development of a prognostic prediction model for anti-amyloid antibody therapy in Alzheimer's disease' on July 10.

Study Type: Observational

Primary Sponsor: Institute - Kansai Medical University

Condition: Condition - Mild cognitive impairment, dementia Classification by malignancy - Others Genomic information - YES

Objective: Narrative objectives1 - This study aims to prospectively enroll patients with Alzheimer's disease or suspected Alzheimer's disease who are considered for initiation, discontinuation, or resumption of anti-amyloid antibody therapy at Kansai Medical University Hospital and Kansai Medical University Medical Center. The study will evaluate prognosis, adverse events including amyloid-related imaging abnormalities, behavioral and psychological symptoms, cognitive function, and physical function, with the aim of developing prediction models for clinical outcomes and adverse events. Basic objectives2 - Others

Eligibility: Age-lower limit - Not applicable Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1) Patients with suspected mild cognitive impairment or mild Alzheimer's disease who are considered for initiation or discontinuation of anti-amyloid antibody therapy. 2) No age restriction. 3) Both outpatients and inpatients are eligible. 4) Both sexes are eligible. 5) Patients who provide written informed consent after receiving sufficient explanation. If the patient is unable to provide valid consent due to cognitive impairment, written consent may be obtained from a legally acceptable representative. Key exclusion criteria - 1) Patients for whom written consent cannot be obtained from the patient or family member/representative. 2) Patients judged by the principal investigator to be inappropriate for participation in the study. Target Size - 500

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2024 Year 05 Month 02 Day Date of IRB - 2024 Year 09 Month 03 Day Anticipated trial start date - 2024 Year 09 Month 03 Day Last follow-up date - 2031 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071025

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