Complete Announced during: After hours · announced Wed 4:55p ET (after hours); before = Wed close; first trade Wed 4:58p ET; time = SEC 8-K acceptance
Alto Neuroscience (NYSE: ANRO) reported topline results from a Phase 2 trial of ALTO-101 in schizophrenia on April 1, 2026. The company said the trial did not meet its primary endpoint. ClinicalTrials.gov lists 82 planned participants (NCT06502964).
Trial details
- Drug
- ALTO-101Type Drug
- Treats
- Studied as a treatment for schizophrenia.Conditions Schizophrenia, Cognitive Impairment
- Patients
- 82 patients (anticipated enrollment)2 arms · 14 sites in 1 country
- Phase
- Phase 2
- Design
- Randomized, quadruple-blind, placebo-controlled, crossover
- Primary endpoint
- Theta band activity (Treatment Period 1 – Day 6 and Day 11; Treatment Period 2 – Day 6 and Day 11)
- Key secondary endpoints
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] ALTO-101T compared to placebo
- Result
- Missed endpoint
- Sponsor
- Alto Neuroscience NYSE: ANRO
- Dates
- Study start Jun 11, 2024Primary completion Feb 2026 (anticipated)Announced Apr 1, 2026, 4:55 PM ET (SEC 8-K filing time)
- Trial ID
- NCT06502964 ClinicalTrials.gov
About this trial
This randomized, quadruple-blind, placebo-controlled, crossover Phase 2 trial (NCT06502964) tested ALTO-101 in Schizophrenia and Cognitive Impairment. Studied as a treatment for schizophrenia. It planned to enroll 82 patients across 2 arms at 14 sites in 1 country. The primary endpoint was Theta band activity (Treatment Period 1 – Day 6 and Day 11; Treatment Period 2 – Day 6 and Day 11). Alto Neuroscience reported that the trial did not meet its primary endpoint. The study started on Jun 11, 2024 and is expected to reach primary completion in Feb 2026.
Sources
- Source: SEC EDGAR 8-K (EX-99.1)
- ClinicalTrials.gov record: NCT06502964
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