WORLD – Biogen and Eisai have presented a design of the first real-world observational phase 4 study in Alzheimer’s disease by the name ICARE AD-US.

ICARE AD-US, a prospective study of Aduhelm (aducanumab-avwa) solution for injection, is designed to collect real-world, long-term effectiveness and safety data on Aduhelm.

The study design includes an important goal to help address the common underrepresentation of Black/African American and Latinx patients in Alzheimer’s disease studies, aiming to enroll at least 16 percent of the trial’s expected 6,000 participants from these communities.

ICARE AD-US is a real-world study that will provide information on the long-term effectiveness and safety of ADUHELM as prescribed in routine clinical practice in the U.S. based on the label approved by the U.S. Food and Drug Administration (FDA).

The primary objective of the study is to characterize and evaluate real-world, long-term changes in cognition, function and neuropsychiatric status in ADUHELM-treated patients.

Secondary objectives are related to gaining a better understanding of ADUHELM safety in real-world clinical practice.

The study intends to enroll patients with Alzheimer’s disease over four years from approximately 200 sites in the U.S. Patients will be monitored for a period of up to five years.

This study will become the third clinical programs designed to generate new data about Aduhelm with the others including Embark, that is an ongoing phase 3b study; Emerge and finally Engage study.

Aduhelm has been at the center of controversies and a number of shareholders in the medical space have been divided due to different opinions about the drug.

Many doctors believe the U.S. Food and Drug Administration “moved the goalposts” to approve Aduhelm (aducanumab) in early June, and they aren’t inclined to recommend its use, this is according to Dr. Ken Lin, a family physician with MedStar Georgetown University Hospital in Washington, D.C.

But one doctor involved in Aduhelm’s clinical trials believes the FDA’s move was necessary to pump new energy into Alzheimer’s research, which had been stagnating with the repeated failure of countless potential treatments.

However, the Cleveland Clinic, as well as Mount Sinai in New York City, each announced this month that they will not administer Aduhelm to patients. Other major medical centers and insurance companies are reviewing the drug’s use with a wary eye.

The medicine’s disputed effectiveness is the main bone of contention, but its steep price also plays a role in the debate. Biogen has set the list price for Aduhelm at US$56,000 a year.

It could cost the federal government US$29 billion a year if just one-quarter of patients now receiving Medicare-covered treatments for Alzheimer’s are prescribed the drug, according to a recent Kaiser Family Foundation analysis.

To put this to contest, the highlighted price tag would be US$6billion more than it would cost the US federal government to fund its moon exploration trip that stood at US$23billion.

Biogen is determined to make Aduhelm a trusted therapy for Alzheimer’s disease under its various trial phases meant to test its safety.