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

Diagnostic and Statistical Manual of Mental Disorders, 5th edition criteria and confirmed

by the Mini-International Neuropsychiatric Interview version 7.02

concomitant medication section) within 4 weeks prior to baseline for oral

medications and within 2 months for depot medications,

current severe major depressive episode (moderately severe depression is allowed)

medications and within 2 months for depot medications) on up to 2 antipsychotic

therapies (oral or depot) other than clozapine

present study, defined as signing the informed consent form until completion of the last

study visit

formulation

screening or has any suicidal ideation that meets criteria at a level of 4 or 5 by using the

Columbia Suicide Severity Rating Scale (C-SSRS) or who is at significant risk to commit

suicide

aminotransferase [AST], alanine aminotransferase [ALT], total bilirubin [TBL]) or a

result > 1.5 times above the upper limit of normal (ULN) at screening or repeated within

1 week prior to potential randomization (day 1). In such a case, the assessment may be

repeated once

gastrointestinal, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic,

pulmonary, neurologic, dermatologic, history of seizure disorder, renal and/or other major

disease or malignancy

laboratory tests at screening or at admission to the study (day 1)

per meter squared at screening and subjects will be discontinued from treatment only for

decreases in the GFR that are clinically relevant

diastolic blood pressure > 100 mmHg at screening. These assessments may be repeated

screening period)

female subjects) at screening or at randomization. If the mean QTcF exceeds the limits

above, one additional triplicate ECG can be taken on day 1

per week for females. (Note 1 unit = 12 ounces of beer, 4 ounces of wine, or 1 ounce of

spirits)

antibodies (immunoglobulin M) (anti-HAV [IgM]) or hepatitis C virus antibodies (anti-

HCV) at Screening or has history of a positive test for human immunodeficiency virus

type 1(HIV-1) and/or type 2 (HIV-2)

consciousness for 1 hour or greater

is longer, prior to screening