s-CitAD: Escitalopram for agitation in Alzheimer's disease

Agitation requiring pharmacological intervention is commonly seen in the Alzheimer’s disease (AD) population and in residents of assisted living facilities, posing a burden on families and caretakers. A previous multi-institutional collaborative study (Citalopram in Agitated Dementia [CitAD] trial) administered a real-world-usable psychosocial intervention to people with agitation in AD who were also randomized to receive citalopram (30mg/day) or placebo.

The findings suggested that citalopram was effective for agitation in AD, where 40% of people that received both the psychosocial intervention and citalopram showed a substantial clinical benefit, while only 26% of those that received the psychosocial intervention plus placebo showed significant clinical improvement. Clinical benefit from citalopram was seen from a particular formulation of this medication (escitalopram), whereas some adverse effects or cognitive impairments were attributed to an alternate formulation.

The proposed study intends to extend on these findings in a real-world environment to define subgroups of people that are most likely to respond to particular treatments, thereby optimizing the treatment of agitation in AD. Specifically, the research will observe the benefit and safety of a treatment algorithm in those that are not responsive to the psychosocial intervention. This will be a placebo-controlled, double-blinded, 24-week, randomized controlled trial done at 24 to 30 sites. The study is sponsored by the National Institute on Aging.