Journal article

Phase 1 randomized study on the safety, tolerability, and pharmacodynamic cognitive and electrophysiological effects of a dopamine D-1 receptor positive allosteric modulator in patients with schizophrenia

Amit Desai, Lauren Benner, Ruishan Wu, Lev Gertsik, Paul Maruff, Gregory A Light, Tolga Uz, Gerard J Marek, Tong Zhu

Neuropsychopharmacology | SPRINGERNATURE | Published : 2020


ASP4345, a novel dopamine D1 receptor positive allosteric modulator, is being evaluated for the treatment of cognitive impairment associated with schizophrenia (CIAS). This phase 1 multiple ascending-dose study (NCT02720263) assessed the safety, tolerability, and pharmacodynamics of ASP4345 in patients with schizophrenia/schizoaffective disorder. Pharmacodynamic assessments were Cogstate cognitive tests and electrophysiological biomarkers, including gamma-band power and phase synchronization in response to 40-Hz auditory steady-state stimulation, as well as mismatch negativity (MMN) and P3a event-related potentials. The sample size determination was based on standard practice in assessing sa..

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University of Melbourne Researchers