Rexulti has become the first FDA-approved treatment for agitation associated with dementia due to Alzheimer’s disease.

Agitation is a common symptom in people with dementia and can involve restless behaviours such as pacing, verbal and physical aggression, and emotional distress. According to the Frontiers Journal of Neurology, agitation is observed in up to 70% of patients with cognitive decline, and ranges from 30-50% in those with Alzheimer’s disease.

Dementia is an umbrella term for several neurological conditions associated with the progressive decline of brain functioning. According to the World Health Organization, more than 55 million people have dementia worldwide, and there are nearly 10 million new cases every year.

Alzheimer’s disease is a progressive, irreversible brain disorder that affects memory and thinking. It is the most common form of dementia and may contribute to 60-70% of all cases.

The effectiveness of the Rexulti oral tablets was determined through two 12-week, randomised, double-blind, placebo-controlled, fixed-dose studies. Progress was measured through the Cohen-Mansfield Agitation Inventory total (CMAI) score – a tool that rates the frequency of certain agitative behaviours in people with dementia. In both studies, patients who received 2mg or 3mg of the drug showed statistically significant – and meaningful improvements – in their total CMAI scores.

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