ABC
1Drugs
2BrandLY3002813
3Genericdonanemab
4MOAN3pG mab (pyroglutamate modification), theorized to remove existing plaque. No affinity for any other AB form (!)
5IndicationEarly Symptomatic Alzheimer's Disease
6AdministrationIV
7
8Phase II "TRAILBLAZER-ALZ" n=272 Early Symptomatic AD - NCT03367403, NEJM 2021
9LY3202626 (BACE) also studied
10iADRS -6.86 vs -10.06 for placebo, p=0.04 at 76 weeks
11CDR-SB -0.36 (baseline 3.5), ADAS-COG13 -1.86 at 76 weeks (27.6 baseline)
12
13
14Phase III "TRAILBLAZER-ALZ 2" n=1800 "Early AD" - NCT04437511
1578-week study; prodromal AD, mild AD