Aducanumab is the new remedy, the first ever Alzheimer can slow down. It is approved in the USA – and highly controversial.
Alzheimer’s drug approved in the USA – will we soon?
For Alzheimer’s sufferers and their relatives it is the only glimmer of hope in a desperate situation, for the manufacturer Biogen a billion dollar business – for many scientists and doctors, aducanumab is one thing above all: too little researched.
Nevertheless, the American Food and Drug Safety Authority (FDA) approved the novel active ingredient against Alzheimer’s at the beginning of June 2021.
A medical sensation: The active ingredient aducanumab or Aduhelm (US brand name) is the first drug ever to fight the disease itself. In the case of Alzheimer’s dementia, it has so far only been possible, if at all, to reduce the symptoms with medication. Now, in theory, aducanumab should slow down the progression of mental decline in every Alzheimer’s patient, regardless of the stage. A medicine revolution? It’s very controversial. This is not the only reason why it will take some time before the drug comes onto the market in Germany – if at all. Read here how the new Alzheimer’s drug works, everything about the research, and what makes aducanumab approval so problematic
How Alzheimer’s occurs and how aducanumab is supposed to stop it
Aducanumab is a monoclonal antibody, which means that it works in the body like a kind of vaccination. The goal of a normal vaccination is to produce antibodies that work against a pathogen. Alzheimer’s is not about viruses or bacteria to be fought, but the goal is something else – the protein beta-amyloid. How Alzheimer’s occurs and why beta amyloid plays a major role in it:
To make the human brain so efficient, more than 100 billion nerve cells work together, constantly processing information and stimuli. So that the network works, the nerve cells are connected via contact points, so-called synapses. The exchange takes place via the synapses through messenger substances. You are the first to be affected by Alzheimer’s, so that the communication between the nerve cells no longer works properly – the first disturbances appear, e.g. increased forgetfulness, concentration and orientation problems.
➔ This is how you can recognize the first signs of Alzheimer’s disease and act!
In the further course of the disease, nerve cells die completely, they are irretrievably lost. This leads to drastic symptoms, which can be very individual depending on the Alzheimer’s patient – also how quickly the disease progresses is very different. Alzheimer’s has four stages that can extend over up to 20 years. In the third and fourth stages, those affected often suffer from:
- Loss of short-term memory and long-term memory disruption, e.g. sudden memories from childhood.
- Loss of the ability to recognize faces, including those of close relatives.
- Disturbed sense of time and disturbed day / night rhythm.
- Disorientation, nervousness, distrust, often the need to run away.
- Speaking, swallowing, and moving become difficult or impossible.
In short: the brain gradually stops functioning. But what destroys this once powerful organ? Despite intensive research, it is still not known exactly why some people develop Alzheimer’s and others do not. What is certain, however, is that two factors lead to the destruction of nerve cells: the protein beta-amyloid and the protein building block tau protein.
Beta amyloid occurs naturally in the brain and is completely harmless in itself. Beta amyloid arises from a biochemical reaction. In Alzheimer’s disease, this process changes, so that defective beta-amyloid proteins are created. They accumulate and clump, thereby forming indissoluble deposits between the nerve cells, the plaques. In addition, there is a modified tau protein, i.e. a protein building block, in the nerve cells.
Tau proteins help move nutrients from one cell to another. In Alzheimer’s disease, the tau protein changes so that it is deposited in the nerve cell, causing it to lose its shape and break down.
Alzheimer’s goes back to the fact that nerve cells in the brain are damaged by protein deposits. This is where aducanumab comes in. The active ingredient reduces the plaques from the protein beta-amyloid in the brain, as studies clearly show. There is great disagreement about everything else.
Why the approval of the Alzheimer’s drug is so controversial
It was an unusual move by the US Food and Drug Administration – they have now granted aducanumab marketing authorization, but only on condition that further research takes place. Normally, all studies and tests with patients must be completed before a new drug can come onto the market. However, when it comes to treating Alzheimer’s, the situation is complex, not to say desperate. It is better to use a remedy that might just prevent patients from losing weight further than to have no remedy at all, so the argument of patient representatives and Alzheimer’s relatives. In addition, precious time should not be wasted. Because even aducanumab is not able to cure Alzheimer’s or reverse the damage, the disease can only be prevented from progressing – maybe.
How effective aducanumab really is is highly controversial and cannot yet be determined with certainty. Because it’s not clear whether a decrease in amyloid beta is really enough to stop Alzheimer’s disease. The clinical tests by the manufacturer Biogen do not show a clear picture, but rather two contradicting phase 3 studies. Phase 3 of approval studies is an examination with a large number of patients, one group of whom receives the new drug and another group is treated as usual or receives a placebo preparation. The comparison of the results should show whether the remedy is effective and also what side effects occur. In the case of aducanumab, a phase 3 study showed that the active ingredient could slightly slow down the mental decline in Alzheimer’s patients. Another study, however, showed no clear effect. As a result, the studies were stopped prematurely because aducanumab did not appear to have any benefits for those affected – it was unethical to continue exposing people to a novel drug with potential side effects if it does not help anyway.
However, manufacturer Biogen then stated that further data had been evaluated and found that a particularly high dose of aducanumab had positive effects after all. The decline in mental abilities and memory is said to have been slowed down by about 22 percent. This means that the mental decline, calculated over a period of one and a half years, could be postponed by about four months. After many debates from various scientific committees, the FDA has now decided to grant approval in order to give Alzheimer’s patients and their relatives the chance of more time in better health.
How do you rate the Alzheimer’s drug in Germany?
In this country people are a lot more cautious about the potential of aducanumab. The assessment of the Alzheimer Research Initiative eV, which promotes education and independent scientific research on Alzheimer’s:
“We welcome the decision of the FDA to approve the Alzheimer’s active ingredient aducanumab on the condition that the manufacturer Biogen submits another study on the effectiveness of the drug. (…) The approval shouldn’t raise false hopes. Aducanumab can also reduce Alzheimer’s disease. It does not cure the disease, it slows down the loss of memory to a small extent. For patients in a very early stage of the disease, this can bring about a temporary noticeable stabilization of cognitive abilities and quality of life. “
So it doesn’t help, doesn’t it hurt? Unfortunately, no. Because even if Alzheimer’s patients are people at the end of their life, the possible side effects of aducanumab must not be forgotten. “The effect is offset by serious side effects and extensive, close-knit medical supervision. One side effect of the active ingredient is brain swelling, which can lead to cerebral haemorrhage undetected. Therefore, participants in the approval studies were examined at regular intervals with imaging procedures such as MRI The dose was suspended. Such accompanying examinations would also have to be carried out regularly on patients, “the Alzheimer Research Initiative points out.
Treatment would not be done with the administration of the drug, accompanying examinations could mean further stress, especially for Alzheimer’s patients, and make acceptance more difficult. Another problem is that although aducanumab can theoretically be used in any stage of Alzheimer’s dementia, those affected often no longer have the mental abilities to make an active decision.
What are the next steps with patient studies on aducanumab?
Aducanumab can currently only be prescribed in the USA, and there are no clinical studies on the active ingredient in this country that patients can participate in. The European Medicines Agency (EMA) will likely decide towards the end of the year whether aducanumab should be approved in the EU. The manufacturer Biogen had submitted an application for this.
The EMA first decides on the approval on the basis of study data from the USA. There, Biogen was obliged to carry out additional studies after the market launch, which should clearly demonstrate how much aducanumab improves cognitive abilities. The company has nine years to do this. An approach that worries many scientists. They fear that it will be very difficult to find participants for a placebo-controlled study.
Why should Alzheimer’s patients get involved and maybe only get the dummy drug when they can simply get aducanumab prescribed? Just one of the many stumbling blocks on the way to effective Alzheimer’s therapy. After all, two other active ingredients are currently in the trial phase and could come onto the market within the next few years, perhaps with greater effectiveness. The Alzheimer’s Research Initiative is cautiously optimistic about this new class of drugs:
“So far, there are no drugs in the drug therapy of Alzheimer’s disease that affect the basic mechanisms of the disease. The drugs that have been used to date stimulate brain performance, and side effects of the disease, such as depression, can be treated. Aduhelm takes action against this the protein deposits in the brain that are characteristic of Alzheimer’s disease. “
Anyway: Social contacts and exercise therapy help with depression in Alzheimer’s sufferers better than medication, studies show.
Alzheimer’s is and will remain an incurable disease, which is one of the reasons why prevention is so important. After all, there is now some knowledge about measures that can protect you. This is especially important for women, because they are more often affected by Alzheimer’s disease.
You can find even more information on detection and prevention and also on the behavior of relatives on our Alzheimer’s topic page.
At the Alzheimer Research Initiative eV you will find explanations of the current state of Alzheimer’s research and medical background knowledge.