Bio­gen launch­es Phase IV tri­al to see just how well Aduhelm works in the re­al world

It could be years be­fore Bio­gen wraps up its con­fir­ma­to­ry tri­al for its con­tro­ver­sial new Alzheimer’s drug Aduhelm (up to nine years, to be pre­cise). But in the mean­time, the com­pa­ny is launch­ing a re­al-world, Phase IV study to eval­u­ate the long-term ef­fects of the drug — this time, with a fo­cus on re­cruit­ing more pa­tients from mi­nor­i­ty groups.

Bio­gen and Ei­sai are look­ing for 6,000 Alzheimer’s pa­tients with mild cog­ni­tive im­pair­ment or mild de­men­tia to par­tic­i­pate in an ob­ser­va­tion­al study dubbed ICARE AD-US, the part­ners shared Thurs­day at the Alzheimer’s As­so­ci­a­tion In­ter­na­tion­al Con­fer­ence. Af­ter tak­ing Aduhelm, pa­tients in the study will be mon­i­tored rough­ly every six months for a to­tal of five years, as re­searchers look for changes in cog­ni­tion, func­tion and neu­ropsy­chi­atric sta­tus.

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.

SIGN UP LOG IN BECOME A PREMIUM SUBSCRIBER