- Intra-Cellular Therapeutics (NASDAQ:ITCI) commences a Phase 3 clinical trial, ITI-007-201, assessing lead product candidate ITI-007 for the treatment of agitation in patients with dementia, including Alzheimer's disease (AD).
- The double-blind, placebo-controlled study will randomize ~360 subjects 1:1 to receive a daily oral dose of 9 mg of ITI-007 or placebo for four weeks. The primary endpoint is the treatment effect compared to placebo as measured by a 37-item scale called Cohen-Mansfield Agitation Inventory - Community version (CMAI-C) which measures the ability of a drug to reduce the overall frequency of agitation symptoms, including aggressive behaviors.
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ITI-007 combines 5-HT2A serotonin receptor antagonism, dopamine receptor phosphoprotein modulation, glutamatergic modulation and serotonin reuptake inhibition in one drug.
- As many as 60% of AD sufferers experience agitation.
- ITI-007 is also under development for the treatment of bipolar depression and schizophrenia.