141 different medicines are being tested in Alzheimer disease clinical trials for the treatment of Alzheimer’s disease. 78% of these drugs are designed to delay the progression of the condition. We look at three drugs that have showed the most promise thus far: lecanemab, donanemab, and remternetug.
What treatments are available for Alzheimer’s disease?
Alzheimer’s disease causes brain cells to get unwell and eventually die, resulting in symptoms such as memory loss.
To treat Alzheimer’s disease, we need to discover potent drugs that can stop or slow its development. These drugs are often referred to as ‘disease-modifying’ medicines.
There are presently no disease-modifying medicines available in the UK for any kind of dementia, including Alzheimer’s disease.
No new Alzheimer’s disease drug has been authorised in the recent 20 years.
The drugs that are now available only treat the symptoms of Alzheimer’s disease. They do not treat the underlying cause of the sickness, which accelerates its progression.
Amyloid, a protein, develops plaques in the brains of people suffering from Alzheimer’s disease. These plaques are thought to be toxic and to destroy the brain’s nerve cells.
Sir Professor John Hardy’s work, which was funded by the Alzheimer’s Society, was the first to show the importance of amyloid protein in the aetiology of Alzheimer’s disease more than 30 years ago.
Since then, researchers have developed drugs that may eliminate amyloid from the brain. These drugs are known as immunotherapies. They want to degrade the amyloid plaques that have collected in the brains of Alzheimer’s patients.
Immunotherapies are now used in medicine, such as the treatment of different cancers.
Researchers believe that eliminating amyloid plaques from the brain might slow the onset of Alzheimer’s disease.
In this article, we look at three drugs that work in this way and have shown promise as Alzheimer’s disease treatments.
1. Donanemab and Alzheimer’s illness
Donanemab should be described.
Donanemab is the immunotherapy drug that has lately made headlines due to the announcement of the topline outcomes from its most recent clinical research.
An intravenous drip is administered to patients using a liquid drug in a bag that enters a person’s bloodstream through a catheter.
What happened to Donanemab recently?
Eli Lilly, the pharmaceutical company that developed donanemab, has recently disclosed early data from the TRAILBLAZER-ALZ 2 study, the donanemab final stage (phase 3) clinical trial. The experiment’s 1,182 individuals had amyloid in their brains and had indicators of memory and cognitive difficulties.
The study found that donanemab may slow the decline of memory and reasoning ability in early-stage Alzheimer’s patients by 36%.
The study’s positive conclusion was a 40% slower drop in everyday chores such as driving, participating in hobbies, and managing money. Donanemab efficiently removed amyloid from the brains of more than 70% of participants over the course of 18 months.
Following the positive results, the donanemab maker is anticipated to submit an application for donanemab clearance to the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA). Following acceptance, it will be reviewed by the National Institute for Health and Care Excellence (NICE). Donanemab would need to be approved by the MHRA and NICE before it could be made available on the NHS in the UK.
Donanemab is also being utilised in a number of other research. The TRAILBLAZER-ALZ 3 research is looking at donanemab therapy to determine whether it may reduce or halt the course of Alzheimer’s disease. In Alzheimer disease clinical trials known as TRAILBLAZER-ALZ4, donanemab therapy was compared to that of aducanumab, another anti-amyloid medicine that is currently only approved for the treatment of Alzheimer’s disease in the United States.
2. Lecanemab and Alzheimer’s disease
Eisai Pharmaceuticals created the immunotherapy medicine lecanemab, also known as BAN2401 and marketed as Leqembi. It is meant for people with early-stage Alzheimer’s disease and is supplied by intravenous drip.
It has already been approved in the United States and has been shown to be effective in delaying the progression of Alzheimer’s disease; decisions from EU and UK regulatory agencies are due in 2024.
What occurred lately with lecanemab?
The US Food and Drug Administration (FDA) approved lecanemab as a medication for early-onset Alzheimer’s disease in January 2023. As a consequence, persons in the United States with early-stage Alzheimer’s disease may now be able to acquire it. It was also revealed that a request for the European Medicines Agency to authorise the treatment in the EU had been made, and that the medication will be marketed as Leqembi.
Clarity-AD, a final (3rd) stage Alzheimer disease clinical trials on lecanemab, presented its full data at the Clinical Trials on Alzheimer’s Disease conference on November 29, 2022, before to the news of lecanemab’s approval.
The study found that lecanemab successfully removed tau and amyloid proteins from the brains of people with early-onset Alzheimer’s disease.
This indicates that the lecanemab group reduced the decline of cognitive capacity and memory by 27%. It also avoided a 56% slower decline in quality of life.
These exciting results have the potential to dramatically change the sector. They give us hope that people with early-onset Alzheimer’s disease may be able to spend more time with their loved ones in the future.
Where might I get lecanemab?
Before it may be used, lecanemab must be approved by drug regulatory bodies as a safe and effective treatment.
United States of America
As of may now be given to persons in the United States with early Alzheimer’s disease after FDA approval in January 2023. This, however, has no influence on whether or not lecanemab will be available in other countries.
The pharmaceutical industry asked the European Medicines Agency (EMA) to authorise lecanemab for usage in the European Union. We estimate that the EMA will advise the European Commission on whether lecanemab should be approved for use in Europe in the first half of 2024.
Before Lecanemab to be bought in the UK, it would need to be approved by the Medicines and Healthcare Products Regulatory Agency (MHRA). The Government has said that the MHRA would follow European Commission regulations after Brexit until January 2024. The United Kingdom has yet to determine if lecanemab will be approved for use there.
The MHRA’s clearance does not ensure that it will be available via the NHS. Lecanemab would also need to be approved by the National Institute for Health and Care Excellence (NICE). When reaching this decision, NICE will consider the benefits and drawbacks of the therapy as well as its cost-effectiveness.
3. Alzheimer’s disease and Internet usage
What exactly is online gaming?
Eli Lilly also manufactures remternetug, another intriguing amyloid-targeting immunotherapy drug, alongside donanemab. It is classified as a second generation immunotherapy since it targets the same kind of amyloid as donanemab but is expected to work better. It is also for those who are in the early stages of Alzheimer’s disease. Patients are also getting it in a different way.
Other immunotherapies for Alzheimer’s disease are delivered intravenously through drips. This may take up to an hour and requires people to visit a clinic in order to get their medicine. In the trial of remternetug, injections under the skin are compared to this treatment. This is done in the hopes that it will be more effective and have fewer side effects than other immunotherapy drugs. Furthermore, it provides a more comfortable method of administration, analogous to insulin pens for diabetics.
What is the most recent advancement in remternetug?
In November 2018, Eli Lilly delivered remternetug to 36 healthy volunteers in a small phase 1 trial to assess the drug’s absorption into the bloodstream and safety. The results were not made public, but a second exploratory study to investigate the safety of remternetug on people with mild-to-moderate Alzheimer’s disease started in July 2020. This study is scheduled to finish in January 2024.
Parallel to this research, a larger-scale phase 3 remternetug trial (dubbed TRAILRUNNER-ALZ 1) began in August 2022. This is done to determine if remternetug is safe and effective for a larger group of people with mild Alzheimer’s disease. They will compare and contrast the two methods of giving the drug. The experiment is set to conclude in 2025.
While the full results of the Alzheimer disease clinical trials will not be known for some months, early data shows that remternetug may be more successful at removing amyloid than donanemab. According to the findings, 75% of the 41 people assessed six months following treatment had their brains cleared of amyloid. Donanemab, on the other hand, required 18 months to entirely eradicate amyloid from 72% of people.
These trials will provide us a plethora of information on the benefits of using immunotherapies to eliminate amyloid protein from the brain.
Before a drug may be sold in the UK, it must be approved by the MHRA. The MHRA carefully examines each Alzheimer disease clinical trials data, using this information to determine if the medication is both safe and effective as a treatment.
Could a breakthrough Alzheimer’s disease therapy be made available via the NHS?
A drug would also need to be approved by the National Institute for Health and Care Excellence (NICE) before it could be acquired via the NHS.
When reaching this decision, NICE will examine the cost-effectiveness of a therapy.
This might be the beginning of the end for Alzheimer’s disease.
Lecanemab and donanemab are the exciting first steps in our quest to find new drugs that can reduce or cure dementia-causing diseases. More research will be conducted on these treatments in order to develop more effective strategies to delay or stop Alzheimer’s disease in its tracks.
However, it is not all. Dementia is caused by a number of different brain illnesses, each of which damages brain cells in a different way.
It is critical to do research to identify what is going on within the brain.
Using this knowledge, researchers will develop novel, cutting-edge medicines to treat all types of dementia.
The Alzheimer’s Society is committed to sponsoring leading researchers who will one day develop more effective, personalised medicines to benefit all individuals living with dementia.
The Alzheimer’s Society funds research into the causes, treatments, care, and prevention of dementia. If you are able, please consider making a gift to support our work.