Michael C. Irizarry, United States of America
Eisai Inc Neurology Business GroupAuthor Of 2 Presentations
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EFFICACY AND SAFETY OF ELENBECESTAT IN SUBJECTS WITH EARLY ALZHEIMER'S DISEASE: RESULTS FROM THE MISSIONAD PHASE 3 PROGRAM
Abstract
Aims
To evaluate the BACE inhibitor elenbecestat in early Alzheimer’s Disease (EAD).
Methods
The MissionAD program comprised two randomized, placebo-controlled phase 3 studies. Patients with EAD were randomized 1:1 to either once-daily elenbecestat (50 mg) or placebo for 24 months. The primary endpoint was CDR-SB at 24 months in the combined studies. Key secondary endpoints included AD Composite Score (ADCOMS) and amyloid PET.
Results
Following recommendation of the elenbecestat DSMB, the studies were terminated early due to an unfavourable risk-benefit ratio. 2209 patients were treated (elenbecestat:1101;placebo:1108) and 189 had a 24-month CDR assessment. No differences were observed in least squares (LS) mean [SE] change from baseline in CDR-SB at 24 months (elenbecestat: 1.99 [0.146]; placebo: 2.17 [0.142]; LS mean difference [95% CI]: -0.17 [-0.57, 0.22]). For ADCOMS at 24 months, no differences were observed in LS Mean (SE) change from baseline (elenbecestat: 0.23 [0.015]; placebo: 0.24 [0.014]; LS mean difference [95% CI]: -0.02 [-0.06, 0.02]). LS mean (SE) change from baseline in amyloid PET centiloids at 24 months was -5.02 (2.046) for elenbecestat and 7.81 (2.500) for placebo (LS mean differences [95% CI] was –12.83 [-18.79, -6.88], nominal p<0.001). Incidence of adverse events were similar between groups with lymphopenia, rash, dizziness, weight loss, and abnormal dreams occurring more frequently with elenbecestat.
Conclusions
There was no evidence of a treatment effect on CDR-SB or ADCOMS for elenbecestat in the early terminated MissionAD studies.
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