NCT06502964 Study of ALTO-101 in Patients With Schizophrenia
| NCT ID | NCT06502964 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Alto Neuroscience |
| Condition | Schizophrenia |
| Study Type | INTERVENTIONAL |
| Enrollment | 82 participants |
| Start Date | 2024-06-11 |
| Primary Completion | 2026-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 82 participants in total. It began in 2024-06-11 with a primary completion date of 2026-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 and measures of cognition. Additional goals are to assess pharmacokinetic (PK), safety, and tolerability of the recently developed ALTO-101T transdermal delivery system (TDS) formulation in a patient population.
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06502964 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, up to 55 Years, studying Schizophrenia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06502964 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06502964 currently recruiting?
Yes, NCT06502964 is actively recruiting participants. Contact the research team at clinical@altoneuroscience.com for enrollment information.
Where is the NCT06502964 trial being conducted?
This trial is being conducted at Garden Grove, United States, Los Angeles, United States, Orange, United States, Walnut Creek, United States and 10 additional locations.
Who is sponsoring the NCT06502964 clinical trial?
NCT06502964 is sponsored by Alto Neuroscience. The trial plans to enroll 82 participants.
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