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Lecanemab in Early Alzheimer's Disease NEJM 2023 - Coggle Diagram
Lecanemab in Early Alzheimer's Disease NEJM 2023
Methods
Trial design
1:1 ratio to receive lecanemab 10mg/kg q2wks or placebo
18 month double blind placebo controlled trial involving persons with early Alzheimer's disease
Eligibility
Participants 50-90 years of age, with either MCI or mild AD on basis of National Institute on Aging-Alzheimer's Association criteria
End points
Primary end point: change on the CDR-Sum of Boxes from baseline at 18 months
Secondary end points
Amyloid burden on PET
Score on 14 item ADAS-cog14
ADCOMS
ADCS-MCI-ADL score
Biomarkers in CSF and plasma
Results
Participants
1795 underwent randomization, 898 assigned to treatment and 897 to placebo
729 in treatment group and 757 in placebo group completed the trial
Endpoint results
Change in CDR-SB was 1.21 in treatment group, and 1.66 in placebo group (p<0.001)
In modified ITT group, change from baseline in ADAS-Cog14 was 4.14 in treatment group and 5.58 in placebo group (p<0.001)