ALTO-101 / Alto Neurosci, MEDRx - LARVOL DELTA

ALTO-101-201: Study of ALTO-101 in Patients With Schizophrenia (clinicaltrials.gov) - P2 | N=82 | Recruiting | Sponsor: Alto Neuroscience | Trial completion date: Nov 2025 ➔ Mar 2026 | Trial primary completion date: Oct 2025 ➔ Feb 2026

Trial completion date • Trial primary completion date • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Psychiatry • Schizophrenia

Alto Neuroscience Receives FDA Fast Track Designation for ALTO-101 for the Treatment of Cognitive Impairment Associated with Schizophrenia (Businesswire) - "Our Phase 1 data, which demonstrated significant and clinically relevant effects of ALTO-101 on both EEG measures and cognitive performance in healthy subjects, provides strong validation for its mechanism."

Fast track • Schizophrenia

ALTO-101-201: Study of ALTO-101 in Patients With Schizophrenia (clinicaltrials.gov) - P2 | N=72 | Recruiting | Sponsor: Alto Neuroscience

New P2 trial • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Psychiatry • Schizophrenia

Pro-Cognitive Pharmacodynamic Effects of ALTO-101: Results from Brain and Behavioral Outcomes in a Randomized, Double-Blind Phase 1 Study (ASCP 2024) - "These findings demonstrate strong PD effects of ALTO-101 in driving key brain processes important for cognition as measured by EEG, along with behavioral evidence of cognitive improvement. Since these measures index schizophrenia-related deficits in cognition and cognitive processing, these data support further development of ALTO-101 for the treatment of cognitive impairment associated with schizophrenia."

Clinical • P1 data • PK/PD data • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Psychiatry • Schizophrenia