Clinical Trials of the Anti-Amyloid Treatment, Aducanumab, has been halted due to shocking results

The termination of the aducanumab trials was the latest setback in the field of Alzheimer’s disease research. It also has renewed debate among researchers regarding the best approach to target the disease.

Hopes that a drug that targets amyloid-beta buildup might be the breakthrough that Alzheimer’s disease (AD) patients and families have longed for were dashed in March when two phase 3 trials were halted because the drug wasn’t showing effectiveness.

The monoclonal antibody aducanumab had been viewed as a promising development for Alzheimer’s disease before Biogen and its Japanese partner Eisai, Co., Ltd. announced their decision March 21 to end global clinical trials of the drug through the ENGAGE and EMERGE trials because a futility analysis of data found that the studies were unlikely to meet the desired results.

The companies did not provide specifics on the trials, saying instead in a news statement that detailed data “will be presented at future medical meetings to inform ongoing research.” The companies said that considering the disappointing results, they were also discontinuing other studies of aducanumab, including the EVOLVE phase 2 safety study and the long-term extension of the PRIME phase 1b study.

The termination of the aducanumab trials was the latest setback in the field of AD research, which has not yet delivered a disease-modifying therapy. It also served to renew the debate among researchers regarding the best approach to target AD. Some researchers believe that targeting the build-up of amyloid-beta (Abeta) plaques could help reduce the disease’s cognitive decline, while other researchers think it makes sense to focus on tau (tangles).

Aducanumab was being tested in patients with mild cognitive impairment due to AD and mild AD dementia. The phase 3 trials were assessing the effectiveness of monthly doses of aducanumab compared with placebo in slowing cognitive and functional impairment as measured by changes in the Clinical Dementia Rating-Sum Boxes (CDR-SB) score. The studies also included some secondary outcomes measures.

“Initiation of the aducanumab phase 3 secondary prevention trial will be assessed while the other data from ENGAGE and EMERGE are further evaluated,” the news release said.

 

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