The primary purpose of this study is to evaluate safety of lecanemab in the real-world clinical setting as reported by events of amyloid-related imaging abnormalities (ARIA)-edema (ARIA-E), ARIA-hemosiderin deposition (ARIA-H), symptomatic ARIA-E, symptomatic ARIA-H, and intracerebral hemorrhage (ICH) greater-than 1 centimeter (cm) in participants treated with lecanemab.
Study Type
OBSERVATIONAL
Enrollment
3,000
This is a non-interventional study.
Eisai Trial Site #1
Nutley, New Jersey, United States
RECRUITINGIncidence of Adverse Events of Special Interest (AESIs)
AESI will include ARIA-E, ARIA-H, symptomatic ARIA-E, symptomatic ARIA-H, and ICH greater-than 1 cm.
Time frame: Up to 6 years
Exposure-adjusted Incidence Rate of AESIs
AESI will include ARIA-E, ARIA-H, symptomatic ARIA-E, symptomatic ARIA-H, and ICH greater-than 1 cm.
Time frame: Up to 6 years
Incidence of Seizure, Anaphylaxis and Death
Time frame: Up to 6 years
Exposure-Adjusted Incidence Rate of Seizure, Anaphylaxis and Death
Time frame: Up to 6 years
Incidence of AESIs Based on Baseline Characteristics
Baseline characteristics will include apolipoprotein E4 (APOE4) genotype, baseline magnetic resonance imaging (MRI) findings, prior Alzheimer's disease (AD) treatments, and antithrombotic therapy.
Time frame: Up to 6 years
Exposure-adjusted Incidence Rate of AESIs Based on Baseline Characteristics
Baseline characteristics will include APOE4 genotype, baseline MRI findings, prior AD treatments, and antithrombotic therapy.
Time frame: Up to 6 years
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