A Real World Study of Lecanemab Treatment in Participants with Early Onset Familial Alzheimer's Disease
The goal of this observational study is to learn about the efficacy of Lecanemab treatment for early-onset familial Alzheimer's disease (AD) in patients under 65 years of age with a family history of AD. Participants will receive Lecanemab at a dosage of 10 mg/kg every two weeks for a total of 18 months and will undergo cognitive assessments, PET and MRI scans, blood/fluid tests and whole genome sequencing. The study will explore the effects of genetic and hereditary factors on the efficacy of Lecanemab treatment in early-onset familial AD patients.
• Age at onset ≤ 65 years, with a minimum age of 18 years; no restriction on gender.
• Diagnosis of Alzheimer's Disease (AD) and Mild Cognitive Impairment (MCI): Must meet the clinical diagnostic criteria for AD-related MCI and mild AD as defined by the National Institute on Aging and the Alzheimer's Association (NIA-AA) (2011); confirmed Aβ positivity through Aβ-PET/CT, Aβ-PET/MRI, or cerebrospinal fluid testing.
• MMSE ≥ 21 or MoCA ≥ 17 or CDR = 0.5
• No significant signs found in the neurological examination
• Participants must be capable of completing cognitive assessments and other tests.
• Informed consent must be obtained from the participants and their legal guardians, with a dated signature, prior to any operations or tests related to the protocol, committing to comply with the research procedures and cooperate throughout the study process.