New Alzheimer’s drug Aducanumab – What is it?

In the next year the first vaccine to be approved for Alzheimer’s disease. The manufacturer, Biogen announced now. Studies with Aducanumab showed improved brain performance in affected patients. Experts explain what this development means for the treatment of Alzheimer’s disease.

Currently, around 1.7 million people in Germany suffer from Alzheimer’s disease. In the year 2050, it should be up to three million. The disease is currently considered incurable.

Hope in the fight against the Forgotten is now a highly controversial media: The anti body against Beta-Amyloid, Aducanumbab, is designed to combat harmful deposits in the brain. As the manufacturer, Biogen announced now, to get the active ingredient in the next year, a approval in the USA. The company announced in the framework of the conference Clinical Trials on Alzheimer’s Disease (CTAD) in San Diego.

Can Plaques disappear: So Aducanumab acts

The antibody Aducanumab is injected into the bloodstream. “The drug binds to Protein clumps, called amyloid plaques that accumulate in Alzheimer’s disease in the brain and nerve cell damage,” explains Christian Haass, the holder of the chair for biochemistry at the Ludwig-Maximilian-University (LMU) in Munich. As a result, the active ingredient highlighted in the deposits, the immune system recognizes them as harmful to the proteins and attacks them with specialized feeding cells. This causes the Plaques to shrink.

The discussions of the active ingredient are not new. In 2016, the studies gave first references to improved brain performance in patients, which was Aducanumab been administered.

Alzheimer’s cloth: Parallel studies

The company Biogen had investigated the drug in two other parallel studies (“Emerge” and “Engange ends”). In the clinical studies, Doctors and researchers at the Institute for stroke and dementia research (ISD) of the LMU University hospital and the German center for Neurodegenerative diseases (DZNE) in Munich were involved.

Both studies were stopped in March 2019 after an interim analysis in advance, and as a failure classified. At that time, Biogen was informed of the supposed Alzheimer’s vaccine Aducanumab be ineffective.

A renewed and extended analysis of the data should now have shown, however, that the antibody is present in high doses – to be able to reduce the cognitive decline in Alzheimer’s patients in the early stages. On this basis, Biogen will apply for 2020, an approval for Aducanumab.

“Break in the immune therapy research”

“The current results of the Emerge study demonstrate for the first Time, a positive effect of immune therapy on the mental performance of patients with Alzheimer’s disease,” explains Michael Ewers, responsible for Brain Imaging and biomarkers at the ISD. “This is a turning-point in the immune therapy research, which has been running for 20 years.”

Not to incite “premature hopes”

Due to the premature termination of the study, the data set was smaller than planned. Therefore, the study could not be fully assessed. Add to this that the results of the “Emerge”study, study “Engage” could only be partially confirmed by the Parallel.

To this end, Katharina citizens, who ran the “Emerge”study on the ISD: “It would be an absolute novelty, if Aducanumab a certain number of Patients in the course of the disease slowed down, it can be.”, the upper declared a doctor of the memory clinic. “However, we should not incite hasty hopes.”

Side effects cost make the use in everyday life complicated

Although most of the patients showed no symptoms, isolated the active ingredient, however, led to side effects such as bleeding in the brain and water retention in the brain, these were in the MRI visible. “The potential adverse effects make the use of Aducanumab in everyday life complicated, because the patients for the control of investigation must for the MRI,” explains citizens.

Stefan Lichtenthaler from the DZNE added: “Even if Aducanumab should lead to a significant slowdown in the rate of memory loss is still unclear, how the necessary, massive amounts of this antibody and a reasonable price can be.”

“Approval is currently difficult to predict”

“How long will it take to to a marketing authorisation of the active ingredient and how the approval will look like, is currently not known and difficult to estimate”, explains Katharina citizens. In Europe, Biogen had asked for no testing.


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