2023-07-17 18:23:09
In people with early symptomatic amylode-positive Alzheimer’s disease treated with donanemab, cognitive and functional decline are significantly slowed. These are the results of the phase 3 study (Trailblazer-Alz 2) – explains a note released today by the pharmaceutical company Lilly – shared at the 2023 edition of the Alzheimer’s Association International Conference (Aaic) underway in Amsterdam, and simultaneously published in the ‘Journal of the American Medical Association’ (Jama).
These results “give hope to people with Alzheimer’s disease who urgently need new treatment options – says Huzur Devletsah, president and general manager of Lilly Italy Hub – This is the first phase 3 study in which a therapy capable of modifying the progression of the disease replicates the positive clinical findings seen in a previous study. If approved, we believe donanemab could provide people with Alzheimer’s disease with clinically meaningful benefits, as well as the ability to complete their course of treatment as early as 6 months after the amyloid plaque has been cleared. In an already complex Alzheimer’s disease healthcare ecosystem, we must continue to remove any barriers to accessing amyloid-targeted diagnosis and therapy.”
Lilly previously announced that donanemab met its primary endpoint and all secondary cognitive and functional endpoints in its Phase 3 clinical trial. Last quarter, the US Drug Agency (FDA) filed for approval for the treatment of people with amyloid-positive early symptomatic Alzheimer’s disease (mild cognitive impairment or mild dementia), regardless of their baseline tau level. The decision is expected by the end of the year. Submissions to other Regulatory Authorities around the world are currently underway, most of which will be completed by the end of the year.
In the Trailblazer-Alz 2 study, participants were stratified by their level of tau, a predictive biomarker for disease progression, into a low-medium tau arm (sometimes referred to as intermediate tau) or a high tau arm, which represented a later pathological stage of disease progression. All participants were then assessed over 18 months, using scales that measure both cognitive and functional ability, including the integrated Alzheimer’s Disease Rating Scale (iAdrs) and the Clinical Dementia Rating-Sum of Boxes (Cdr- Sb).
Donanemab significantly reduced amyloid plaque levels regardless of disease stage at baseline by a mean of 84% at 18 months, compared with a 1% decrease for participants on placebo. The results show that nearly half of the participants treated in early stage disease showed no clinical progression at one year. Further subpopulation analyzes showed treatment earlier in the disease had an even greater benefit, with a 60% slower decline than placebo. Additionally, the treatment effect continued to increase versus placebo throughout the study, even though many participants completed the 6- or 12-month course of therapy, supporting the limited-duration dosing.
“These results demonstrate that diagnosing and treating people earlier in the course of Alzheimer’s disease can lead to a relevant clinical benefit – underlines Alessandro Padovani, president of the Italian Society of Neurology and director of the Institute of Clinical Neurology at the Spedali Civili of Brescia – The delay in disease progression over the course of the trial is significant and can give people more time to do things that are meaningful to them. People living with early and symptomatic Alzheimer’s disease – remember – continue to work, enjoy travel, share quality time with family: they want to feel like themselves, longer. The results of this study – concludes Padovani – reinforce the need to diagnose and treat the disease earlier than is done today”.
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