What do we know so far about the new Alzheimer’s drug trial?
A new drug designed to prevent Alzheimer’s disease is being tested at more than 100 centers around the world and is called lekanemab.
The drug consists of antibodies that bind to abnormal proteins that accumulate in the brains of people with Alzheimer’s disease.
Previous efforts to target these proteins have resulted in little or no improvement in the patient’s symptoms, for reasons that are still not well understood.
The researchers hope the new drug will be more effective because it is given early in the disease, before brain function begins to decline.
Alzheimer’s disease is a brain disease that slowly destroys memory and thinking abilities.
Although the causes of the disease are not yet fully understood, the accumulation of abnormal proteins in the brain is usually accompanied by brain shrinkage, inflammation, and damage to blood vessels.
Some suffer from a genetic mutation that more than doubles the risk of developing the disease.
But many people who have these mutations do not develop Alzheimer’s disease, and conversely, many people who do not have the mutation do.
Here’s what you should know about property:
Who is eligible to study?
Participants must be between the ages of 55 and 80 and have normal brain function.
Their brains must also have accumulated some of the abnormal proteins thought to play a role in causing Alzheimer’s disease. These sticky proteins are called beta-amyloids and can be identified using imaging of the brain called positron emission tomography (PET).
These tests are expensive and are only offered to potential study participants after they have had an initial blood test, which is less accurate than a CT scan but can rule out people without amyloid in the brain.
How can I register for a trial?
The trial was funded by the National Institutes of Health and several charities, as well as the Japanese antibody company Eisai.
The study is being coordinated by the University of Southern California Institute for Therapeutic Alzheimer’s Disease Research, Brigham and Women’s Hospital, Massachusetts General Hospital and Harvard Medical School.
The experiment has been running since mid-2020, but will run until October 2027, with many sites still registering participants.
The goal is to recruit 1,400 participants, half of whom receive doses of the drug itself and the other half receive a placebo. Volunteers first receive injections every two weeks and then move on to a monthly schedule for four years.
Those interested in participating in the study can visit AHEADstudy.org.
What does the drug do?
The antibodies in the drug are designed to recognize and attach to beta-amyloid, abnormal proteins in the brain.
When antibodies bind to these protein molecules, the immune system responds by removing them from the brain to get rid of them.
In a previous study published last November, the drug significantly reduced amyloid levels in the brains of people with early symptoms of the disease. But the effect on participants’ cognitive ability was relatively modest.
The researchers have already submitted the results of this study to the Food and Drug Administration, which is expected to review the drug for possible approval sometime in 2023. This means weighing the benefits against the risks of side effects, which can include swelling and bleeding in the brain.
The researchers hope the new study will prove the drug is more effective when given to people without symptoms.
Why does the drug name end in -mab?
Drug names often look like someone randomly picked letters from the alphabet, but there is a way to do it.
The letters mab at the end of the drug name refer, as in the case of lekanemab, to the monoclonal antibody.
Antibodies are Y-shaped proteins produced by the immune system. But they are made for medical use by genetically cloning a single type of cell, hence the term “monoclonal.”
Source: Medical Express