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Agitation in Alzheimer's dementia

Psychiatry· 2 reviewed drugs· 4215 cited findings behind them

What the regulatory reviews cover

Regulatory review documents in this library for the treatment of agitation associated with Alzheimer’s dementia include Rexulti. Rexulti's indication is for the Treatment of agitation associated with Alzheimer’s dementia, as well as Adjunctive Treatment of Major Depressive Disorder.

Different drugs were studied in different trials, so the figures presented are not head-to-head comparisons. For Rexulti, the CMAI Total Score change from baseline at Week 12 (LS mean difference vs placebo) was -2.34. The CGI-S change from baseline at Week 12 (LS mean difference vs placebo) was -0.31. In three 12-week Phase 3 studies, the total deaths in the brexpiprazole arm were 8, representing 1.2% of participants, while the placebo arm had 1 total death.

The drugs — one cited result each

Rxulti

Otsuka Holdings Co., Ltd.

2326 cited findings on the drug page →
Rexulti

Otsuka Holdings Co., Ltd.

CMAI Total Score change from baseline at Week 12 (LS mean difference vs placebo): -2.34

Rexulti FDA Review (NDA205422, S, p.96

Different drugs were studied in different trials — these figures are not head-to-head comparisons.

Explore the full evidence

Every finding behind these drugs — searchable, comparable and answerable in plain language — is in the Psychiatry research library →

Lists reflect the regulatory review documents in this library, not all therapies that exist. Educational reference only — not medical or investment advice.

Agitation in Alzheimer's dementia — 2 Drugs, FDA & EMA Review Findings | BioPharmaPT Psychiatry