These promising results offer hope to people with Alzheimer’s disease by providing new treatment options to slow its progression.
Il anti-amyloid treatment with donanemab has shown positive results in slowing cognitive and functional decline in people with Alzheimer’s disease Alzheimer early symptomatic positive for amyloid, according to a phase 3 study entitled “Trailblazer-Alz 2”, shared during the 2023 edition of the Alzheimer’s Association International Conference (Aaic) in Amsterdam. The results of the study were also published in the “Journal of the American Medical Association” (Jama).
Pharmaceutical company Lilly announced that donanemab treatment met the primary endpoint and all secondary cognitive and functional endpoints in the Phase 3 clinical study. Therefore, they have completed their filing with the US Drug Agency (FDA) for the treatment of early symptomatic amyloid-positive Alzheimer’s disease (mild cognitive impairment or mild dementia), regardless of baseline tau level. The approval decision is expected by the end of the year, and other regulatory authorities around the world are evaluating the submissions, with most expected to be completed by the end of the year.
In the Trailblazer-Alz 2 study, participants were divided according to the level of tau, a predictive biomarker for disease progression, into a low-medium tau arm or a high tau arm, representing more advanced disease stage. All participants were assessed for 18 months using scales measuring both cognitive and functional ability, including the integrated Alzheimer’s Disease Rating Scale (iAdrs) and the Clinical Dementia Rating-Sum of Boxes (Cdr-Sb).
Treatment with donanemab significantly reduced amyloid plaque levels, with an average reduction of 84% at 18 months, compared with a 1% decrease in the placebo group of participants. The results showed that about half of the participants treated in the early stages of the disease showed no clinical progression after one year of treatment. Additional analyzes revealed that early treatment led to a slowdown in cognitive decline by 60% compared to the control group. Furthermore, the treatment effect continued to improve compared to placebo throughout the study, even though many participants completed the course of therapy at 6 or 12 months, supporting the idea of a time-limited dosing.
These promising results offer hope to people living with Alzheimer’s disease by providing new treatment options to slow disease progression and improve quality of life. Early diagnosis and treatment of Alzheimer’s disease appears crucial to maximizing clinical benefits and giving people more time to maintain a meaningful level of functioning. The study findings underscore the importance of removing barriers to accessing amyloid-targeted diagnosis and therapies, enabling timely and targeted treatment for those who need it.
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