#AAN2022 – Real-world Trial of Aduhelm Now Enrolling Patients in US

Marta Figueiredo, PhD avatar

by Marta Figueiredo, PhD |

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Biogen is continuing to actively recruit Alzheimer’s patients for its Phase 4 ICARE AD-US trial, which is evaluating the long-term safety and effectiveness of Aduhelm (aducanumab) in the real-world U.S. clinical setting.

Participants — including a targeted enrollment of 16% Latino and African American patients — are currently being enrolled at more than 10 sites in the U.S., with up to 200 sites expected to open. Further information on contacts and locations can be found here.

ICARE AD-US is a Phase 4 trial — one that begins after a medicine has been approved by regulators and is usually conducted to check a therapy’s performance in real life.

The trial’s design was outlined at the 2022 American Academy of Neurology Annual Meeting (AAN), held in Seattle April 2–7 and virtually April 24–26. A poster titled “ICARE AD-US: Design of a Prospective, Single-Arm, Multicenter, Noninterventional, Real-World Study of Aducanumab in the United States” was presented by scientists working with Biogen.

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Aduhelm, developed by Biogen alongside Eisai, is an antibody-based therapy designed to clear the toxic clumps of beta-amyloid protein that are thought to drive neurodegeneration in people with Alzheimer’s.

The therapy was granted accelerated approval in the U.S. last year for early-stage Alzheimer’s.

That limited approval was based on clinical trial results showing that Aduhelm reduced amyloid-beta clumps in the brain. Full approval of Aduhelm is dependent on further demonstrations of clinical benefits in additional trials, known as Phase 4 confirmatory trials.

Biogen is gearing up to launch such a trial, dubbed ENVISION, which is expected to begin enrolling participants in May.

Notably, an application seeking Aduhelm’s approval in Japan is currently under review. Meanwhile, an application submitted to health authorities in the European Union was recently withdrawn by Biogen due to indications that available data, to date, were not sufficient to support an approval.

ICARE AD-US is seeking to recruit up to 6,000 adults in the U.S. with Alzheimer’s — including about 500 African American and 500 Latino patients. The goal of this trial is to evaluate Aduhelm’s five-year safety and effectiveness in real-world U.S. clinical practice.

The therapy will be administered directly into the bloodstream (intravenously) once a month, consistent with its approved label.

The study is expected to involve about 200 centers “representing diverse Alzheimer’s disease care settings (e.g. academic centers, memory clinics), with broad geographical representation across the US,” the researchers wrote.

The main endpoints or goals of ICARE AD-US are to assess changes in cognitive function, ability to perform daily life activities, neuropsychiatric status, and quality of life. Disease burden and health care resource utilization are other key goals.

“Clinical measures were selected based on their sensitivity to change in early-stage Alzheimer’s disease and their feasibility in routine clinical care,” the researchers wrote.

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Secondary goals include multiple safety measures, such as the frequency and severity of adverse events (side effects), the frequency and clinical outcomes of amyloid-related imaging abnormalities–edema (ARIA-E), and the frequency of ARIA associated with symptoms.

ARIA, or abnormalities suggestive of swelling (edema) or bleeding on brain scans, were previously reported in some Aduhelm-treated patients and are often associated with amyloid-targeting therapies.

Researchers also will obtain data on the characteristics of the Aduhelm user population and on therapy utilization. Blood samples from participants also will be collected throughout the trial for biomarker studies.

Clinical visits and study assessments will be conducted about every six months. However, such checkpoints may vary, as they will occur within the context of standard-of-care and will not be mandatory.

ICARE AD-US “will collect a harmonized core dataset to assess the long-term effectiveness and safety of [Aduhelm] treatment in real-world clinical practice,” including “in patients from underrepresented racial and ethnic minority groups,” the researchers wrote.

Note: The Alzheimer’s News Today team is providing coverage of the American Academy of Neurology (AAN) 2022 Annual Meeting.