RightFit
RecruitingPhase 2

Study of ALTO-101 in Patients With Schizophrenia

Double-Blind, Placebo-Controlled Study of ALTO-101 in Patients With Schizophrenia and Cognitive Impairment

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
21 Years to 55 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Mentioned in the study description

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Mentioned in the study description
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Official 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

Study sites (14)

CA

FL

GA

IL

MA

MD

NY