For the first time: the drug that will put an end to one of the most difficult symptoms of dementia patients
- Meital Yasur Beit-Or
- Published in Israel Today
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The FDA has approved a new drug to treat one of the severe symptoms suffered by Alzheimer's patients - and it is not considered an antipsychotic drug • "For the first time, there is apparently a possible treatment - and without side effects," said a senior physician at the Rambam Stroke Institute • "This symptom is the main reason families hospitalize the patient" • The article includes a comment from Prof. Yehudit Aharon-Peretz, chair of the scientific advisory committee of the EMDA Association.
Does not belong to the antipsychotic drug family
The US Food and Drug Administration (FDA) has approved a new drug to treat "agitation," a serious symptom suffered by Alzheimer's patients.
Restlessness in these patients may manifest itself in aggressive behavior such as tantrums, shouting or violent behavior, repetitive movements, mental restlessness such as continuous crying, anxiety, difficulty cooperating in daily activities such as bathing or dressing, and more.
The approved drug, Auvelity, is the first to be approved for this indication and does not belong to the antipsychotic drug family. A step that is considered a breakthrough in the field.
"A very complex symptom"
According to Dr. Tiffany Parcione, a senior director at the FDA's Center for Drug Evaluation, "Agitation is one of the most complex and difficult symptoms to manage in Alzheimer's patients. This approval provides another treatment option for patients suffering from this condition."
The FDA emphasized that the new approval reflects significant progress in an area where there is a lack of effective treatment solutions. "There is a significant unmet need for safe and effective treatments for agitation associated with Alzheimer's, and this approval is an important step forward," the statement said.
The drug was developed by Axsome Therapeutics and works through a unique mechanism that affects neurochemical systems in the brain related to regulating behavior, mood, and emotional responses.
The approval is based on data from several clinical studies, which demonstrated that the treatment significantly reduced the severity of agitation compared to placebo. The treatment has side effects including dizziness, abdominal pain, diarrhea, and dry mouth. There is even a warning of the risk of drowsiness in those taking the treatment in combination with antidepressants.
The current approval comes after the FDA first approved a dedicated treatment for the phenomenon about three years ago: the antipsychotic drug Rexulti. However, this drug includes a "black box" warning due to an increased risk of mortality among elderly people with limiting dementia, which led to a search for safer alternatives.
The drug Auvelity was added to the Israeli drug basket about two months ago for the treatment of major depression as a third-line treatment after exhausting treatment with two previous drugs. Unlike existing drugs that take time to improve the patient's condition, with this drug, benefit may occur within a week. The drug is not yet registered in Israel for the current indication.
"The reason the family is hospitalizing the patient"
Prof. Yehudit Aharon Peretz, a senior physician at the Rambam Stroke and Cognition Institute and chair of the scientific council at the association EMDA Association (Dementia and Alzheimer's patients) explains: "In all conditions that cause cognitive decline and dementia, there may be behavioral disorders called agitation or restlessness. This is one of the most important phenomena for the patient's daily life and also for the family, to the point that one of the reasons the family cannot cope with the patient and hospitalizes him is behavioral disorders. This is restlessness, violence, and lack of sleep. This is a very uncomfortable situation for the family."
She said, "Restlessness occurs in 60-70 percent of Alzheimer's patients and may occur in other conditions such as Parkinson's, blockages in blood vessels in the brain, or after head injuries." She added that "until recent years, the way to deal with it was through two main routes - the first non-pharmacological route - the assumption that some of the behavioral disorders are caused by some kind of distress in the patients that they cannot report. For example, pain, because the patient is unable to report the specific distress - the way is behavioral disorders.
"The first treatment was to rule out an environmental or physical cause. A few years ago, they began using psychiatric medications that are known for violent situations, old-generation and new-generation tranquilizers (Zyprexa, Seroquel, Risperdal or Helidol). These medications may have side effects. And what is very clear is that when all psychiatric tranquilizers are used in patients suffering from dementia of any cause, it increases the risk of stroke and death.
"For the first time, there is a drug that is specifically designed to treat restlessness, and there is an attempt to offer a drug that currently has no warning. And what is certain is that it is not an antipsychotic drug."
"This is the news that for the first time there is apparently a possible treatment to calm the restlessness and without side effects. So far, no dangerous side effects have been reported. Fatigue and dizziness have been reported, but no deaths or strokes."
Prof. Yehudit Aharon-Peretz She is the chair of the Scientific Advisory Committee of EMDA Association and a senior physician at the Institute for Stroke and Cognition, Rambam Medical Center. Previously, director of the Institute for Cognitive Neurology.