NIPH Clinical Trials Search

Prospective Study to Investigate the Long-Term Outcomes in Japanese Patients with Early Alzheimer's Disease who are treated with Lecanemab in the Real World Clinical Setting

Basic Information

Recruitment status	Pending
Health condition(s) or Problem(s) studied	Alzheimer's disease
Date of first enrollment	30/06/2026
Target sample size	750
Countries of recruitment
Study type	Observational
Intervention(s)	none

Outcome(s)

Primary Outcome	time to progression to the next stage of AD as measured by the global Clinical Dementia Rating (CDR)
Secondary Outcome	Change from baseline in MMSE at each evaluation time point Change from baseline in QDRS at each evaluation time point Change from baseline in digital biomarkers at each evaluation time point

Key inclusion & exclusion criteria

Age minimum	Not applicable
Age maximum	Not applicable
Gender	Both
Include criteria	Determined to be appropriate as a treatment candidate based on the indication for lecanemab. A study partner who will provide written consent in a separate document has been identified. Written consent has been obtained for the use of medical information in this study.
Exclude criteria	Participating in an interventional clinical study (e.g., a clinical trial or specified clinical research). A history of exposure to lecanemab. Use of lecanemab is contraindicated.