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Study identifier: NCT06502964 Synced from ClinicalTrials.gov · August 09, 2026
● Study status: Recruiting

Study of ALTO-101 in Patients With Schizophrenia

Condition: Schizophrenia · Cognitive Impairment  ·  Sponsor: Alto Neuroscience

PhasePhase 2
Planned participants82
Who can joinAll sexes, 21 Years to 55 Years
Healthy volunteersNoCheck eligibility criteria ↓
Where14 locations

Interested? Contact the study team ↓

For sponsors, CROs & site teams
Professional view of this study — listed sites, countries and recruiting context from the public registry. Everything below is written for patients and caregivers.See where this study is running →

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Alto Neuroscience  ·  650-200-0412  ·  clinical@altoneuroscience.com

There is no obligation to join — the study team can answer your questions about taking part.

Always discuss trial participation with your own doctor first.

Full eligibility criteria (exactly as the study team wrote them)

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

Reproduced word-for-word from the public registry record — the study team can answer questions about it.

Locations (14)

Site 5038Garden Grove, California, United StatesRecruiting
Site 5063Los Angeles, California, United StatesRecruiting
Site 5106Orange, California, United StatesRecruiting
Site 5035Walnut Creek, California, United StatesRecruiting
Site 5060Hollywood, Florida, United StatesRecruiting
Site 5015Tampa, Florida, United StatesRecruiting
Site 5064Snellville, Georgia, United StatesRecruiting
Site 5056Chicago, Illinois, United StatesRecruiting
Site 5062Gaithersburg, Maryland, United StatesRecruiting
Site 5124Belmont, Massachusetts, United StatesRecruiting
Site 5108New York, New York, United StatesRecruiting
Site 5077New York, New York, United StatesRecruiting

+ 2 more locations — full list on the registry record.

More studies in these areas

This study lists sites in the areas below. Each link shows other recruiting studies near that city, from the public registry record.

Garden GroveLos AngelesOrangeWalnut Creek

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