Aduhelm for Alzheimer’s disease
Last updated Aug. 19, 2025, by Andrea Lobo, PhD
Fact-checked by Ana de Barros, PhD
What is Aduhelm for Alzheimer’s?
Aduhelm (aducanumab) is an antibody that targets amyloid-beta, the protein that builds up inside nerve cells in those with Alzheimer’s disease.
The treatment was granted accelerated approval by the U.S. Food and Drug Administration (FDA) in 2021 to help slow neuronal loss and reduce the progression of cognitive and functional decline in individuals with Alzheimer’s.
Given as an intravenous (into-the-vein) infusion once every four weeks, the treatment’s active ingredient, aducanumab, targets aggregated beta-amyloid, helping to reduce the buildup of amyloid plaques that contribute to nerve cell dysfunction and loss in Alzheimer’s.
The most common side effects associated with Aduhelm use include headaches, falls, and amyloid-related imaging abnormalities (ARIA), which involve brain swelling (ARIA-E) and bleeding (ARIA-H). The drug’s label carried a boxed warning about the risk of serious ARIA, particularly in patients with two copies of the APOE4 variant of the apolipoprotein E (APOE) gene.
In 2024, Biogen, Aduhelm’s developer, discontinued the development and commercialization of Aduhelm due to inconsistent efficacy results in Phase 3 clinical trials, as well as commercial reasons. The company decided to reallocate resources to its other approved Alzheimer’s therapy Leqembi (lecanemab).
Therapy snapshot
| Treatment name: | Aduhelm (aducanumab) |
| Administration: | Given via intravenous infusion once every four weeks |
| Clinical testing: | The treatment was in Phase 4 clinical trial testing, but was discontinued due to inconsistent results regarding its clinical benefits and a lack of commercial acceptance |
Aduhelm in clinical trials
Aduhelm’s conditional approval in the U.S. was based on data from two Phase 3 clinical trials — ENGAGE (NCT02477800) and EMERGE (NCT02484547) — that showed the treatment significantly reduced beta-amyloid plaques in the brain. The trials enrolled nearly 3,500 adults with early-stage Alzheimer’s who had mild cognitive impairment and mild dementia due to the disease. The therapy was tested against a placebo for 1.5 years.
Clinical trial results were not fully conclusive regarding the therapy’s effectiveness, however. The EMERGE trial met its primary goal, showing a significant reduction in the progression of cognitive and functional impairments. But in contrast, the ENGAGE trial did not demonstrate significant differences overall. Importantly, in the ENGAGE trial, only patients who received sufficient exposure to the highest dose of aducanumab showed meaningful benefits.
The treatment was also being tested in the Phase 4 ENVISION trial (NCT05310071), which was designed to confirm Aduhelm’s clinical benefit. All trials were terminated after the company decided to discontinue the treatment.
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