Phase 3 Trial for Agitation in Alzheimer’s, Dementia Patients Initiated by Intra-Cellular Therapies

Phase 3 Trial for Agitation in Alzheimer’s, Dementia Patients Initiated by Intra-Cellular Therapies
New York City-based Intra-Cellular Therapies has started its ITI-007-201 Phase 3 clinical trial for the treatment of agitation in patients with dementia, including Alzheimer's disease, following the company's communication with the U.S. FDA. Intra-Cellular Therapies Chairman and CEO Dr. Sharon Mates said in a press release she is pleased that ITI-007 is advancing into Phase 3 development to treat dementia-associated behavioral problems "as we continue in our mission to provide improved treatment options to patients suffering from CNS disorders." "Agitation associated with dementia imparts considerable distress for patients and burden on their caregivers. Given ITI-007’s unique pharmacology, we believe that its ability to fully occupy serotonin 5-HT2A receptors at low doses, while modestly modulating dopamine D2 and D1 receptors, and inhibit serotonin reuptake will improve a wide range of behavioral disturbances associated with dementia, including agitation," she said. "We believe the favorable safety and tolerability profile of ITI-007 observed in other patient populations will translate well into this new therapeutic area to ease suffering and improve quality of life for patients and their families," Mates added. ITI-007-201 is a multicenter, randomized, double-blind, placebo-controlled Phase 3 cli
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