Study of ALTO-101 in Patients With Schizophrenia
Recruiting · NCT06502964 · Interventional (participants receive a specific treatment) · Lead sponsor: Alto Neuroscience
View the official record on ClinicalTrials.gov →Interventions studied
ALTO-101ALTO-101 Transdermal Delivery SystemPlaceboPlacebo Transdermal Delivery System
What this trial is about
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.
Who can take part
Age range
21 Years to 55 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
14 locations listed across 7 US states.
- Site 5038 - Garden Grove, California, United States
- Site 5063 - Los Angeles, California, United States
- Site 5106 - Orange, California, United States
- Site 5035 - Walnut Creek, California, United States
- Site 5060 - Hollywood, Florida, United States
- Site 5015 - Tampa, Florida, United States
- Site 5064 - Snellville, Georgia, United States
- Site 5056 - Chicago, Illinois, United States
- Site 5062 - Gaithersburg, Maryland, United States
- Site 5124 - Belmont, Massachusetts, United States
- Site 5108 - New York, New York, United States
- Site 5077 - New York, New York, United States
- Site 5109 - New York, New York, United States
- Site 5126 - White Plains, New York, United States