NCT06502964RecruitingPhase 2
Study of ALTO-101 in Patients With Schizophrenia
Double-Blind, Placebo-Controlled Study of ALTO-101 in Patients With Schizophrenia and Cognitive Impairment
Source: ClinicalTrials.gov · Last updated 26 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 82 (estimated)
- First submitted
- 9 Jul 2024
- Start date
- 11 Jun 2024
- Primary completion date
- 28 Feb 2026
- Lead sponsor
- Alto Neuroscience
- Diseases
- Schizophrenia
- NCT number
- NCT06502964
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 82
- From 11 Jun 2024 to the primary completion date, 28 Feb 2026
- 14 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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)
- Current moderate or severe substance use disorder
Other
- Use of mood stabilizer, clozapine, and/or daily benzodiazepine
Who the study is looking for
- 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
Age in the registry: 21 years to 55 years · Sex: All · Does not accept healthy volunteers
Sites (14)
Sites in registry order. Pick your city on the disease page to sort them by distance.
This page is information, not medical advice. Discuss any trial with your doctor.