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Eli Lilly presents data demonstrating relationship between reduction of amyloid plaque and slowing of cognitive decline

Thursday 29 July 2021

On 29 July, Eli Lilly presented data from its Phase II study with donanemab at the Alzheimer’s Association International Conference (AAIC). The TRAILBLAZER-ALZ study was a Phase II, multi-center, randomised and placebo-controlled clinical trial of donanemab in people with early, symptomatic Alzheimer's disease (AD). The study enrolled 272 participants aged between 60 and 85, 131 of whom were assigned to receive donanemab 700 mg every four weeks for the first three doses, then 1400 mg every four weeks, for up to 76 weeks.

The first presentation showed a reduction of the number of amyloid plaques following donanemab treatment at 24 weeks in people with early symptomatic AD. Participants who reached a complete amyloid plaque clearance were able to stop or reduce dosing of donanemab earlier than other participants. In addition, donanemab treatment was associated with less cognitive decline and participants who reached early complete amyloid plaque clearance at 24 weeks showed a significant decrease of tau progression. In the second presentation, Lilly presented data showing that treatment with donanemab resulted in early reduction of plasma P-tau217, which is a blood-biomarker associated with amyloid and tau pathology. This decrease was correlated with significant changes of the level of amyloid plaques.

Donanemab is also being studied in the ongoing Phase III TRAILBLAZER-ALZ 2 study in people with early symptomatic AD. A new Phase III trial, named TRAILBLAZER-ALZ 3, is expected to start recruitment by the end of the year. This study will evaluate whether treatment with donanemab can slow the clinical progression of AD in people who have evidence of Alzheimer's pathology, but don't yet demonstrate clinical symptoms.