First non-antipsychotic drug approved for agitation in Alzheimer's disease
Although Auvelity shows promise, the FDA warns of possible side effects, including an increase in suicidal thoughts.
The Food and Drug Administration(FDA) approved Auvelity a non-antipsychotic tablet medication that offers a new option for treating agitation in adults with Alzheimer's dementia. This approval is significant given existing antipsychotics carry serious risks such as cerebrovascular accidents and an increase in mortality.
Auvelity, which was already approved for the treatment of major depressive disorder, has demonstrated in clinical trials its effectiveness in relieving agitation symptoms in patients with Alzheimer's, affecting neurotransmitters such as glutamate and dopamine.
“We've been needing a drug like this for decades, because the agitation associated with Alzheimer's disease is one of the most difficult and discouraging symptoms we treat,” he told ABC News. Dr. Richard Isaacson, director of research at the Florida Institute for Neurodegenerative Diseases, “This new drug would be used because its tolerability profile is better,” he added.
Warnings and side effects
However, although Auvelity shows promise, the FDA warns of possible side effects, including an increase in suicidal thoughts and other adverse reactions such as dizziness and seizures.
Specialized monitoring is required when initiating treatment. Auvelity was initially approved by the FDA in 2022, but for the treatment of major depressive disorder in adults.
Alzheimer's in numbers
In 2026, approximately 7.4 million Americans 65 years older suffer from Alzheimer's dementia, and this number is expected to 13.8 million by 2060, according to the Alzheimer's Association.
According to a study released by JAMA Neurology, between 50% and 60% of people with Alzheimer's experience symptoms s of agitation at sometime, one of the most common and annoying symptoms for those suffering from Alzheimer's dementia.
Repercussions of Alzheimer's
Alzheimer's disease is a progressive and irreversible brain disorder that profoundly impairs cognitive faculties, resulting in complete functional dependence and a significant emotional impact both for for the patient and their close environment. As neuronal connections break down and cerebral atrophy occurs, the person gradually loses their ability to reason, communicate and perform everyday activities.
Functional impairment and dependency
The progression of the disease manifests through a stepped loss of autonomy that begins with complex tasks and culminates in the need for total care.
Psychological and behavioral impact
The changes in the brain alter mood and behavior, which usually represents one of the biggest challenges for coexistence and daily care.
Future perspectives
Dr. Isaacson stresses the importance of offering not only pharmacological treatments, but also complementary approaches such as exercise and diet.
The growing population affected by dementia demands continuous care and more research in this area.
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