FDA Alert

FDA Approves First Treatment of Agitation in Patients With Alzheimer Dementia

Jessica Ganga

The FDA has approved an oral tablet for the treatment of agitation associated with dementia due to Alzheimer disease. This is the first FDA-approved treatment for this common symptom of Alzheimer dementia.

“Agitation can include symptoms ranging from pacing or restlessness to verbal and physical aggression,” said Tiffany Farchione, MD, director of the Division of Psychiatry in the FDA’s Center for Drug Evaluation and Research, said in a press release. “These symptoms are leading causes of assisted living or nursing home placement and have been associated with accelerated disease progression.”

The approval follows two 12-week, randomized, double-blind, placebo-controlled, fixed-dose studies that examined the efficacy of the treatment. Patients were required to: (1) have a probable diagnosis of Alzheimer dementia, (2) score between 5 to 22 on the Mini-Mental State examination, which determines whether a person is experiencing cognitive impairment, and (3) exhibit the type, frequency, and severity of agitation behaviors that require treatment.

In the first study, patients received either 1 mg or 2 mg dose of the oral tablet, and in the second study, patients received 2 mg or 3 mg of the medication. In both studies, patients who received 2 mg or 3 mg of the medication showed statistically significant and clinically meaningful improvements in total Cohen-Mansfield Agitation (CMAI) Inventory scores when compared to patients who received placebo at week 12. The CMAI survey is a tool used to rate the frequency of certain agitative behaviors in patients with dementia based on input from caregivers.

The most common adverse events associated with the treatment included headache, dizziness, urinary tract infection, nasopharyngitis, and sleep disturbances. The recommended starting dosage for the treatment of agitation using the oral tablet is 0.5 mg once daily on days 1 to 7. Patients should increase the dosage on days 8 through 14 to 1 mg a day. And on day 15, the dosage will increase to 2 mg once a day.



FDA approves first drug to treat agitation symptoms associated with dementia due to Alzheimer’s disease. News release. US Food and Drug Administration; May 11, 2023. Accessed on May 15, 2023.