Donanemab, a monoclonal antibody trained against Aβ plaques, is hot on the heels of its slightly more advanced competitors aducanumab [1] (see Part 1 [2] of the series from Alz Forum), and lecanemab are in the race for regulatory approval. Neck-and-neck with them is gantenerumab. So what’s the latest? At this year’s Clinical Trials in Alzheimer’s Disease meeting, held November 9-12 in Boston and online, scientists from Eli Lilly and their academic partners parsed results from a completed Phase 2b study, reported baseline data from an ongoing Phase 3 trial, and showcased a new, decentralized approach of their prevention trial, also in Phase 3.
- TRAILBLAZER-2, a Phase 3 study, has enrolled 1,600 participants.
- Prescreening with plasma p-tau-181 helped select people with both amyloid and tau pathology.
- A secondary prevention trial, TRAILBLAZER-3, is designed to rely on remote assessments, not clinic visits.
Most of the discussion focused on how best to deploy tau measurements—both PET scans and blood tests—to pick out just the right participants for trials and maybe even gauge how well they will take to treatment. Scientists reported that plasma p-tau-181 works to select people likely to harbor both plaques and tau tangles in the brain, and that those who start on donanemab with few tangles benefitted the most from amyloid riddance. Donanemab slowed, but did not stop, tangle growth. In all, the findings underscored that treating earlier in the course of disease stands a better chance of curbing progression.
Read the full series and reports on progress from this months Clinical Trials in Alzheimer’s Disease (CTAD) Conference – https://www.alzforum.org/ [3]