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Alzheimer's Association Statement on Topline Results of the A4 Trial of Solanezumab

Alzheimer's Association Statement on Topline Results of the A4 Trial of Solanezumab
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March 8, 2023
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CHICAGO, March 8, 2023 — The Alzheimer’s Association is disappointed by the topline results from the Anti-Amyloid Treatment in Asymptomatic Alzheimer’s (A4) Study of solanezumab. The company reported today that solanezumab did not slow cognitive decline in people with preclinical Alzheimer’s disease or reduce risk of progression to symptomatic Alzheimer’s disease compared to placebo.

Because solanezumab was unsuccessful at stopping or slowing the accumulation of amyloid, individuals continued to experience cognitive decline. Recently approved treatments have demonstrated that the clearance of beta amyloid accumulation leads to a clinical benefit. We look forward to learning more about the data and outcomes at the Alzheimer’s Association International Conference (AAIC), July 16-20 in Amsterdam.

The A4 Study was one of the first clinical trials to test an anti-amyloid treatment in the pre-clinical phase, before individuals demonstrated symptoms, but when they had evidence of amyloid plaque build-up in their brains.

“Though we’re disappointed by these data, these results will contribute to our understanding of Alzheimer’s and help us better conduct trials in people in the pre-symptomatic stages of the disease,” said Maria C. Carrillo, Ph.D., Alzheimer’s Association chief science officer. “Even with this news, it is a hopeful time for Alzheimer’s treatments. We now have approved therapies, with more on the way, which is a crucial first step towards safer and more effective treatment of Alzheimer’s disease.”

This was a well-crafted and conducted secondary prevention study that implemented several important practices, including a focus on recruiting a diverse and representative population. In the decade since the A4 study was initiated, there has been tremendous growth in our knowledge and approach to treatment dosage in trials. As a result, the dose of solanezumab was increased throughout the A4 trial. While this drug did not meet its primary or secondary endpoints, these results will expand our understanding of Alzheimer’s disease.

The Alzheimer’s Association is confident about the robust and diverse Alzheimer’s drug development pipeline; we are in a new era of expanding possibilities for Alzheimer’s treatment. More and better options for treatment are desperately needed for people living with all stages of Alzheimer’s.

We know that current anti-amyloid approaches are not a cure, nor will they stop the disease on their own, but they are the first wave of effective treatments for Alzheimer’s. The Alzheimer’s Association is committed to advancing all potential treatment avenues, and exploring combination therapies. The Association’s Part The Cloud initiative has funded 65 innovative clinical trials that explore a wide variety of treatment targets.

The Alzheimer’s Association funded a sister study that leveraged the A4 study infrastructure called the Longitudinal Evaluation of Amyloid Risk and Neurodegeneration (LEARN), which enrolled individuals who did not qualify for A4 because they did not have enough elevated amyloid in the brain, but were otherwise demographically similar. LEARN is monitoring the cognitive, clinical and biological changes in these individuals compared to those in A4, with the goal of developing risk profiles and biomarkers for Alzheimer’s. Thanks to Alzheimer’s Association funding, A4 and LEARN are among the first clinical trials to utilize tau PET brain imaging to track disease progression.

Many Alzheimer’s studies need volunteers, including clinical trials of more than 140 unique therapies. The Alzheimer’s Association’s TrialMatch® program connects individuals living with Alzheimer’s, caregivers and healthy volunteers to a wide variety of studies that advance Alzheimer’s research.

About the Alzheimer's Association

The Alzheimer’s Association is a worldwide voluntary health organization dedicated to Alzheimer’s care, support and research. Our mission is to lead the way to end Alzheimer's and all other dementia — by accelerating global research, driving risk reduction and early detection, and maximizing quality care and support. Our vision is a world without Alzheimer's and all other dementia®. Visit or call 800.272.3900.

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