Symptomatic trial Phase 2 symptomatic trial in mild-to-moderate AD • Daily oral medication • Planned outcomes at 12 months • N = 360 randomized to drug or placebo | Disease modification trial Phase 2/3 disease modification trial for early AD • In-clinic monthly drug infusions • Planned outcomes at 18 months • N = 280 randomized to drug or placebo | |
Trial status on March 19, 2020 | Fully enrolled | Fully enrolled |
97.5% completed 3 months | 80% completed 3 months | |
67% completed 6 months | 50% completed 6 months | |
45% completed 9 months | 25% completed 12 months | |
22% completed 12 months | 12% completed 18 months | |
Dropout | 30% dropout rate evenly distributed across visits. No discontinuation due to COVID19 | 24% (66 subjects) discontinued before or on March 19 (partially due to COVID19). An additional non-COVID dropout rate of 25%. Final dropout rate: 42%a |
Scenario 1 | Trial stopped on March 19; no further visits or data collection | |
Scenario 2 | Outcome assessments paused during COVID interruption, resumed after interruption. | |
• ~ 50%, who had completed 9 months, missed their 12-month outcome • ~ 25% missed their 9-month outcome but could have 12-month assessments • ~ 30% missed other outcomes Medication continued during COVID interruption. | • ~ 50%, who had completed 12 months, missed their 18-month outcome • ~ 25% missed their 12-month outcome but could have 18-month assessments • ~ 50% missed other outcomes Medication infusion paused during COVID interruption, resumed after interruption. | |
Scenario 3 | No outcomes assessed during COVID interruption. Medication continued during COVID, with extended medication provided beyond 12 months Up to a 3-month extension of the final assessment window, to allow completion of 12 months outcomes after clinics reopened | Outcomes assessed remotely during COVID interruption; in-clinic assessment resumed after interruption. Medication infusion paused during COVID interruption No extension of the final assessment window |