Bad results from a promising Alzheimer’s drug

Updated:06/17/2022 12:59h

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The result is not much of a surprise: Roche ended two phase 3 trials of crenezumab in people with prodromal to mild sporadic Alzheimer’s in early 2019 after interim analyzes found it would be futile to continue.

But it’s another blow to the amyloid hypothesis.

And it probably marks the end of the road for crenezumab as well.

The Phase 2 API-ADAD study, groundbreaking research that has been ongoing for more than a decade, looked at crenezumab’s ability to delay or prevent symptoms of Alzheimer’s disease in a population of cognitively healthy people with a specific genetic mutation that causes early-onset Alzheimer’s disease.

The clinical trial was sponsored by Roche, the National Institute on Aging and Banner Alzheimer Foundation.

And probably also marks the end of the road for crenezumab

Subjects enrolled in the study came from an extended family in Colombia with Alzheimer’s disease. autosomal Alzheimer’s (ADAD) associated with Presenilin 1 E280A mutation, leading to cognitive impairment in 40-year-old patients.

They were followed for five to eight years, receiving crenezumab as a subcutaneous injection every two weeks or an intravenous injection every four weeks.

The dose was increased over the course of the study “as knowledge about potential treatment approaches for Alzheimer’s disease evolved,” the company explained in a statement, raising the question of whether to provide a higher dose throughout the study period would have altered the result.

Discussion of that will have to wait until the official presentation of the data at the Alzheimer’s Association International Conference starting in late July, as for now Roche only reveals the main result.

Crenezumab failure shifts attention to Roche’s other late-stage amyloid drug, gantenerumab, being tested for ADA

While ADAD is far less common than sporadic Alzheimer’s, the result is another blow to the amyloid category after a brief period of hype surrounding fast-track approval of Aduhelm (addanumab) by Biogenlast year due to controversial data.

The failure of crenezumab diverts attention to Roche’s other drug targeting late-stage amyloid, gantenerumab, which is being tested for ADAD, as well as for the prevention of sporadic Alzheimer’s and the treatment of people in the early stages of Alzheimer’s. illness.

Before the end of the year, Roche should report the results of two Phase 3 studies in early-stage patients.

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