Last updated on November 2019

A Study to Assess the Safety and Efficacy of ASP4345 as Add-on Treatment for Cognitive Impairment in Subjects With Schizophrenia on Stable Doses of Antipsychotic Medication

Brief description of study

The purpose of this study is to evaluate the efficacy of ASP4345 on cognitive impairment compared to placebo using change from baseline in MATRICS Consensus Cognitive Battery (MCCB) neurocognitive composite score (excluding social cognition domain). The primary estimand will use a Hypothetical Strategy and compare participants as though the participant had continued on the assigned treatment and to evaluate the safety and tolerability of ASP4345 compared to placebo. This study will also evaluate the effects of ASP4345 compared to placebo on functional capacity using the University of California San Diego Performance-based Skills Assessment-2 Extended Range (UPSA-2-ER) total score and evaluate the pharmacokinetic profile of ASP4345 and its metabolites, if necessary.

Detailed Study Description

Participants will receive oral doses of ASP4345 or matching placebo QD (once daily) for 12 weeks. All participants will be administered the first dose of blinded study drug at the site following randomization and provided with web-based applications that provide supplemental cognitive training and record treatment compliance. Participants will return to the clinic weekly for safety, efficacy, and/or pharmacokinetic procedures. Participants will continue the participant's antipsychotic treatment for the entire study and will be followed for 14 days after the participant's last dose of study drug.

Clinical Study Identifier: NCT03557931

Recruitment Status: Closed

Brief Description Eligibility Contact Research Team

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