Schizophrenia Treatment, Brexpiprazole, Seen to Ease Agitation in Alzheimer’s Patients in Phase 3 Trial

Schizophrenia Treatment, Brexpiprazole, Seen to Ease Agitation in Alzheimer’s Patients in Phase 3 Trial
The schizophrenia medication Rexulti (brexpiprazole) reduced agitation in patients with Alzheimer’s disease, newly released data from two Phase 3 clinical trials of the drug show. The studies highlight that efforts are ongoing to target symptoms — other than dementia itself — to improve the quality of life of Alzheimer’s patients and their loved ones. The treatment, developed by Otsuka Pharmaceutical and Lundbeck, was also found safe in this patient group, with a similar side effects profile as was seen in earlier trials in other patient populations. The two studies (NCT01862640 and NCT01922258) enrolled 700 patients diagnosed with probable Alzheimer’s disease and symptoms of agitation. The studies randomized patients to receive either brexpiprazole or a placebo, with neither study staff nor patients aware of the treatment — what's known as a double-blind setup. Both trials investigated brexpiprazole treatment over 12 weeks, but differed in their dosing schedules. The first trial treated patients with fixed doses of either 1 or 2 mg per day, while the other used a flexible range of doses, including 0.5 mg, 1 mg or 2 mg per day. Both, however, focused on the primary outcome measure of lower agitation, assessed using the Cohen-Mansfield Agitation Inventory. Researchers also evaluated agitation using another tool: the Clinical Global Impression-Severity of Illness (CGI-S) score. Interestingly, the first trial showed a robust effect of the treatment in lessening agitation using the first scale, bu
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