How Much Amyloid Clearance, How Fast Is Needed To Slow Alzheimer’s?

Questions Remain But CTAD Data Offer Clues

Lilly’s donanemab showed faster, deeper amyloid clearance versus Biogen/Eisai’s Aduhelm and Roche’s failed Phase III gantenerumab studies showed the importance of deep, rapid removal.

Amyloid plaques forming between neurons
How soon and how much amyloid clearance is needed to provide benefit may be the field's next big area of debate • Source: Shutterstock

Two highly anticipated Phase III readouts, for two different anti-amyloid antibodies, were presented on the second day of the Clinical Trials on Alzheimer’s Disease (CTAD) meeting in San Francisco – the first, for Eli Lilly and Company’s donanemab, with a positive outcome and the second, Roche Holding AG’s gantenerumab, with negative outcomes. The data confirm that removing amyloid from Alzheimer’s patients’ brains can slow disease progression, but questions remain around how fast and deep amyloid clearance must be to offer a significant benefit.

In addition to detailed top-line results from the failed Phase III GRADUATE I and II clinical trials of gantenerumab on 30 November, day two of CTAD included a presentation of Lilly’s Phase III TRAILBLAZER-ALZ 4 clinical trial, which showed that at six months patients with early symptomatic Alzheimer’s disease who were treated with donanemab had more rapid and deeper clearance of amyloid from their

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