Status:
RECRUITING
Study of ALTO-101 in Patients With Schizophrenia
Lead Sponsor:
Alto Neuroscience
Conditions:
Schizophrenia
Cognitive Impairment
Eligibility:
All Genders
21-55 years
Phase:
PHASE2
Brief Summary
This is a Phase 2, double-blind, placebo-controlled, two-way crossover study to compare the efficacy of ALTO-101T versus placebo in change in electroencephalogram (EEG) cognitive processing markers an...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
June 11 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2026
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT06502964
Start Date
June 11 2024
End Date
March 1 2026
Last Update
December 26 2025
Active Locations (14)
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1
Site 5038
Garden Grove, California, United States, 92845
2
Site 5063
Los Angeles, California, United States, 90015
3
Site 5106
Orange, California, United States, 92868
4
Site 5035
Walnut Creek, California, United States, 94596