The re-analysis of data from a Phase 3 study, in which the active substance aducanumab (antibody against aggregated amyloid-β) had previously had to be declared clinically ineffective (due to different results in two double-blind partial studies), showed in October 2019 that aducanumab could after all lead to an improvement in clinical symptoms. This was achieved by a higher dosage of the active substance and a longer period of administration.

At the beginning of 2020, the developers (Biogen) now intend to submit an application for approval of the drug to the US Food and Drug Administration (FDA). It is hoped that the drug will already be effective during the development of Alzheimer's disease, thereby slowing down the disease process. The slowing of the loss of memory, orientation and speech in Alzheimer's patients has now been shown in the second analysis of data from a phase 3 study.

This news is relevant for the project, because the earliest possible diagnosis, which we want to achieve in the IASON project, will become very important if the drug really does lead to success in slowing down the loss of brain function on a large scale. A diagnosis as early as possible is essential in order to intervene as early as possible in the course of the disease, before there is irreversible damage.




Update: for the current status of the approval of Aducanumab see