Observational Study of Lecanemab Treatment for Early-Onset Familial Alzheimers Disease in Adults Aged 18 to 65

What this Trial Is About

Researchers are studying the effects of Lecanemab treatment in patients under 65 years old with early-onset familial Alzheimers disease who have a family history of the condition. This observational study aims to understand how genetic and hereditary factors influence the treatments impact on cognitive function and disease progression. The study is sponsored by RenJi Hospital and focuses on patients diagnosed with Alzheimers disease or mild cognitive impairment related to Alzheimers. Participants will receive Lecanemab at a dose of 10 mg per kg every two weeks for 18 months. During this period, they will undergo various assessments including cognitive tests, PET and MRI scans, blood and fluid tests, and whole genome sequencing. These evaluations will be conducted at baseline, 9 months, and 18 months to monitor changes in brain function and disease markers. Throughout the study, participants will be closely monitored through clinical and imaging assessments, cognitive evaluations, and biomarker analyses. The primary outcome measured is the change in the Clinical Dementia Rating-Sum of Boxes CDR-SB score over time. Secondary outcomes include changes in amyloid levels, cognitive scores, brain imaging results, and speech information. The total participation duration is 18 months, during which safety and efficacy data will be collected.

Lecanemab for Early Onset Familial Alzheimer's Disease