Another Alzheimer's drug on the way – who it can help

The European Medicines Agency (EMA) has cleared the way for another drug to treat Alzheimer's disease. Following a re-examination, the EMA Committee for Medicinal Products for Human Use (CHMP) in Amsterdam announced that it has recommended EU marketing authorization for the antibody donanemab for the early-stage treatment of the disease.

In Germany alone , an estimated 1.2 million people suffer from Alzheimer's disease , but the drug is estimated to be suitable for only about ten percent of them. The drug can neither stop nor cure Alzheimer's disease, but can only slow the progression of the disease somewhat in its early stages.

The EU Commission in Brussels will now decide whether and when donanemab may be used in the European Union. The active ingredient is already approved in the USA, Japan, China, and Great Britain under the product name Kisunla.

Both drugs work in a fundamentally similar way: The antibody targets amyloid deposits in the brain and is intended to slow the progression of the disease in its early stages. Donanemab removes these deposits even more significantly than lecanemab, Peter Berlit, Secretary General of the German Society of Neurology (DGN), told the German Press Agency.

The antibody can slow the progression of the disease by up to six months. "This is, of course, an important period for people with very early-onset Alzheimer's dementia."

However, this treatment is only useful at the beginning of the disease: "We know that these antibodies only help in the very, very early stages of the disease, when there are only mild cognitive impairments," explains the expert.

In other words: At this early stage it must already be established that it is Alzheimer's disease – and not vascular dementia or the beginning of Parkinson's disease .

Similar to lecanemab, donanemab is also only suitable for a specific group of people, according to the EMA experts: those affected may have a maximum of one copy of the ApoE4 gene, which carries the information for the construction of the protein apolipoprotein E.

This genetic marker is more common in people with Alzheimer's disease, explains Berlit. Studies have shown that side effects of the antibodies can include swelling or bleeding in the brain – "especially in people who have one or two copies of this ApoE gene," Berlit says. "If you don't have a copy at all, the risk of complications from such therapies is vanishingly small."

With one copy of the gene the risk is still acceptable, but with two copies it is no longer acceptable.

After an initial rejection, donanemab has now received a recommendation for approval. "During the initial evaluation by the EMA, the experts concluded that the risk of these edema formations and bleeding in the brain was too high" compared to the benefits, Berlit explained.

Now, the approval regulations have been tightened, including the exclusion of certain ApoE4 carriers and the requirement to provide evidence that no vascular constrictions were found during a magnetic resonance imaging (MRI). According to DGN estimates, only around ten percent of the 1.2 million affected patients in Germany are likely to be eligible for this treatment.

The EMA explains that Kisunla therapy should be administered by physicians experienced in diagnosing and treating Alzheimer's disease and with constant access to MRI. Furthermore, the drug should be administered under the supervision of a multidisciplinary team trained in the detection, monitoring, and treatment of brain abnormalities.

1. Exercise: What's good for your heart is also good for your brain. This includes getting enough exercise—at least 2.5 hours per week is ideal.

2. Mental fitness: Learn new things—even as you get older. This keeps your brain active. Whether it's a musical instrument, a language, or learning how to use a computer, try something new.

3. Healthy diet: Follow the classic Mediterranean diet. Eat plenty of fruits and vegetables, olive oil, and nuts. Choose fish instead of red meat.

4. Socializing: Activities are more fun in pairs or in a group, and your brain cells are challenged. Arrange to do sports, play music, play cards, or cook together.

5. Reduce excess weight: Make sure you don't weigh too much. A healthy diet and regular exercise will help you achieve this.

6. Sufficient sleep: Ensure you get good and sufficient sleep so that your brain can eliminate toxins and recover.

7. Don't smoke: Smoking also damages your brain. Quit smoking; it's never too late.

8. Avoid head injuries: Take care of your head in everyday life and during sports, for example, wear a helmet when cycling.

9. Check your high blood pressure: Have your blood pressure checked regularly. High blood pressure should definitely be treated.

10. Check your diabetes: Keep an eye on your blood sugar level. If it's consistently too high, you should take action in consultation with your doctor.

11. Treat depression: Take good care of yourself. If you feel listless or depressed for an extended period of time, it's a good idea to see your doctor to determine the cause. Depression shouldn't go untreated.

12. Pay attention to hearing loss: Take it seriously if you notice that your hearing is deteriorating. A hearing aid can be a great way to correct this decline.