The FDA has approved a new Alzheimer’s drug

The FDA has approved a new Alzheimer’s drug
The FDA has approved a new Alzheimer’s drug

AGI – The US Food and Drugs Administration (Fda) has approved the use of Aduhelm, a drug against Alzheimer’s syndrome. A note reports it. The authorization was awaited with great attention as a new therapy against this disease had not been approved since 2003.

It is the first drug approved by the FDA for Alzheimer’s in nearly two decades, a disease that affects millions of people and their families: almost 6 million cases in the US, 500,000 patients in Italy alone. The FDA approved the drug on the condition that the manufacturer, Biogen, conducts further clinical trials, as the results of the first phase of testing were deemed incomplete.

These results had raised doubts about Aduhelm’s effectiveness, so much so that the FDA’s commission of independent advisers responsible for nerve diseases had expressed an opinion against the authorization of the drug and several experts had advised against its approval.

Aduhelm would be the first drug to intervene directly on the physiological mechanisms of the onset of the disease, or the formation of betamyloid plaques on the brain. The tests showed a reduction of these plaques in patients with the first symptoms of the disease, that is memory loss and first difficulty in reasoning.

The therapy, which consists of monthly injections, has not been attempted on patients with the syndrome in an advanced state. The FDA underlines the great media attention raised by the treatment and warns that the data provided by Biogen “are extremely complex and leave residual doubts about the clinical benefits”.

The US agency acknowledged that “the community of experts offered different perspectives” but explained that it had chosen the accelerated approval procedure, used to provide access to treatments for serious diseases for which there is insufficient treatment, after concluding that “the benefits for Alzheimer’s patients treated with Aduhelm outweigh the risks of the therapy”.

How the disease manifests itself

A sneaky start: People begin to forget some things, then get worse, to the point where they can’t even recognize family members anymore and need help with even the simplest daily tasks.

Alzheimer’s dementia today affects about 5% of people over 60 and in Italy, reads the fact sheet published on the EpiCentro portal of the Istituto Superiore di Sanità, there are an estimated 500,000 sick people. A disease on which new hopes are lit with today’s approval by the American FDA of Aduhelm, the first drug approved since 2003.

The disease affects memory and cognitive functions, affects the ability to speak and think but can also cause other problems including states of confusion, mood swings and space-time disorientation.

An enormous psychological cost for the sick and families, but also significant material repercussions: according to a recent Censis research, the direct cost of assistance alone is 11 billion a year, over 70% borne by families. It takes its name from Alois Alzheimer, a German neurologist who for the first time in 1907 described its symptoms and neuropathological aspects.

On his autopsy examination, the doctor noticed particular signs in the brain tissue of a woman who had died from an unusual mental illness. In fact, he highlighted the presence of agglomerates, later called amyloid plaques, and of bundles of tangled fibers, the neuro-fibrillar tangles.

Today the plaques formed by amyloid proteins and the tangles are considered the effects on the nervous tissues of a disease of which, despite the great efforts put in place, the causes are not yet known. In patients with Alzheimer’s dementia, a loss of nerve cells is observed in areas of the brain vital for memory and other cognitive functions.

There is also a low level of those chemicals, such as acetylcholine, which work as neurotransmitters and are therefore involved in communication between nerve cells.

A slow course

The course of the disease is slow and on average patients can live for 8-10 years after the diagnosis of the disease. Alzheimer’s dementia, as mentioned, manifests itself with slight memory problems, ending with severe damage to brain tissues, but the speed with which the symptoms worsen varies from person to person. During the course of the disease, cognitive deficits worsen and can lead the patient to severe memory loss, to ask the same questions several times, to get lost in familiar places, to the inability to follow precise directions, to be confused about time, people and places, but also to neglect their personal safety, hygiene and nutrition.

However, cognitive impairments can also be present years before a diagnosis of Alzheimer’s dementia is made. Today the only way to make a certain diagnosis of Alzheimer’s dementia is through the identification of amyloid plaques in the brain tissue, possible only with an autopsy after the patient’s death. This means that only a “possible” or “probable” diagnosis of Alzheimer’s can be made during the course of the disease.

For this reason, doctors use various tests: clinical tests, such as blood, urine or spinal fluid tests, neuropsychological tests to measure memory, the ability to solve problems, the degree of attention, the ability to count and talk CT brain to identify any possible signs of abnormality.

These tests allow the doctor to rule out other possible causes that lead to similar symptoms, such as thyroid problems, adverse drug reactions, depression, brain tumors, but also diseases of the brain blood vessels. As in other neurodegenerative diseases, early diagnosis is very important both because it offers the possibility of treating some symptoms of the disease, and because it allows the patient to plan his future, when he is still able to make decisions.

Pharmacological therapies

Finally, drug therapies: to date there are no drugs capable of stopping and regressing the disease and all available treatments aim to contain the symptoms. This is why Aduhelm’s approval could be a fundamental step: it would be the first drug to intervene directly on the physiological mechanisms of the onset of the disease, namely the formation of betamyloid plaques on the brain.

The tests showed a reduction of these plaques in patients with the first symptoms of the disease, that is memory loss and first difficulty in reasoning. For some patients with mild or moderate disease, drugs such as tacrine, donepezil, rivastigmine and galantamine can help limit worsening of symptoms for a few months.

These active ingredients work as inhibitors of acetylcholinesterase, an enzyme that destroys acetylcholine, the deficient neurotransmitter in the brains of Alzheimer’s patients.. Therefore, by inhibiting this enzyme, it is hoped to keep the concentration of acetylcholine intact in patients and thus to improve memory. In addition, other medications can help contain insomnia, anxiety and depression.

The development of new drugs for Alzheimer’s dementia is a field in great development, research laboratories are working on active ingredients that help prevent, slow down the disease and reduce its symptoms. Another active research path is that which focuses on the development of an immunological response against the disease trying to develop a vaccine capable of containing the production of b-amyloid (the peptide that aggregates to form plaques).

Among the various non-pharmacological therapies proposed for the treatment of Alzheimer’s dementia, reality-oriented therapy (ROT) is the one for which there is the greatest evidence of efficacy (albeit modest). This therapy is aimed at orienting the patient with respect to his personal life, the environment and the space that surrounds him through continuous verbal, visual, written and musical stimuli.

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