A Postmarketing Study of Lecanemab for the Treatment of Participants With Alzheimer's Disease
ConditionAlzheimer's Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorEisai Inc.
About this trial
The primary purpose of this study is to evaluate the safety of lecanemab-irmb 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 cm in participants treated with lecanemab-irmb.
The secondary purpose of this study is to:
Evaluate the safety of lecanemab-irmb in the real-world clinical setting as reported by events of seizures, anaphylaxis, central nervous system (CNS) ischemic event, and death.
Assess the safety of lecanemab-irmb when stratified by baseline characteristics including apolipoprotein E (APOE) genotype, baseline magnetic resonance imaging (MRI) findings consistent with a high risk for cerebral amyloid angiopathy (CAA), prior Alzheimer's Disease (AD) treatments, and antithrombotic therapy.
Assess the risk of safety outcomes (ARIA-E, ARIA-H, ICH greater than 1 cm, seizures, anaphylaxis, CNS ischemic event, and death) associated with APOE genotype, baseline MRI findings consistent with high risk for CAA, prior AD treatment, and antithrombotic therapy within participants exposed to lecanemab-irmb in ALZ-NET.
Assess the risk of safety outcomes (ARIA-E, ARIA-H, ICH greater than 1 cm, seizures, anaphylaxis, CNS ischemic event, and death) between participants exposed to lecanemab-irmb in ALZ-NET and subjects exposed to lecanemab irmb in Study 301.
Assess the risk of safety outcomes (ARIA-E, ARIA-H, ICH greater than 1 cm, seizures, anaphylaxis, CNS ischemic event,and death) between participants exposed to lecanemabirmb in ALZ-NET and subjects exposed to placebo (PBO) in Study 301.
Assess the risk of safety outcomes (ARIA-E, ARIA-H, ICH greater than 1 cm, seizures, anaphylaxis, CNS ischemic event, and death) between participants exposed to lecanemab-irmb in ALZ-NET and participants not exposed to anti-amyloid therapies in ALZ-NET.
Assess whether the risk of safety outcomes associated with APOE genotype, baseline MRI findings consistent with high risk for CAA, prior Alzheimer's Disease treatments, and antithrombotic therapy differs between participants exposed to lecanemab-irmb in ALZ-NET versus those not exposed to anti-amyloid therapies in ALZ-NET.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Enrolled in ALZ-NET
Either currently receiving or previously received lecanemab-irmb.
Disqualifiers
None
Trial population
Participants prescribed lecanemab-irmb by a physician participating in the ALZ-NET registry.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
No Intervention
Other interventionThis is a non-interventional study.
Treatment groups
6,700 Participants
are divided into 1 treatment groupGroup A: All Participants1 intervention
Trial outcomes
Primary outcomes
1
Incidence and exposure-adjusted incidence rate of the adverse events of special interest (AESIs) of ARIA-E, symptomatic ARIA-E, ARIA-H, symptomatic ARIA-H, and ICH greater-than 1 cm in diameter
Time frame
Baseline up to Follow-up, up to 10 yearsSecondary outcomes
1
Incidence and exposure-adjusted incidence rate of seizure, anaphylaxis, central nervous system (CNS) ischemic event, and Death
Time frame
Baseline up to Follow-up, up to 10 years2
Incidence Rate of AESIs
Incidence and exposure-adjusted incidence rate of AESIs will be assessed by count (n) and proportion (%) of APOE genotype, baseline MRI findings consistent with a high risk for CAA, prior AD treatments, and antithrombotic therapy.
Time frame
Baseline up to Follow-up, up to 10 years Source ClinicalTrials.gov