Age

21–55

Sex

ALL

Healthy volunteers

Not accepted

Schizophrenia diagnosis for at least one year
Cognitive impairment
Stable doses of 1-2 antipsychotic medication(s) for at least 8 weeks at Visit 2
Positive and Negative Syndrome Scale (PANSS) score: items P1, P3-P6 ≤ 5 and item P2 and P7 ≤ 4 during screening
Have a body mass index (BMI) ≥ 18.0 and ≤ 37.0 kg/m2 (inclusive)
Willing to comply with all study assessments and procedures

Evidence of unstable medical condition
Acute psychiatric decompensation or severity of symptoms requiring psychiatric hospitalization in past 6 months
Diagnosis of schizoaffective or bipolar affective disorder, dementia, or intellectual disability
Current episode of major depressive disorder (MDD)
Use of mood stabilizer, clozapine, and/or daily benzodiazepine
Current moderate or severe substance use disorder

Study of ALTO-101 in Patients With Schizophrenia