NCT06502964 · Alto Neuroscience
Study of ALTO-101 in Patients With Schizophrenia
What this study is about
This is a Phase 2, where neither patients nor doctors know which treatment is given, compared against an inactive treatment, two-way crossover study to compare the effectiveness of ALTO-101T versus placebo in change in electroencephalogram (EEG) cognitive processing markers and measures of cognition.
View original scientific description
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.
Interventions
DRUG
ALTO-101
ALTO-101 patches
DEVICE
ALTO-101 Transdermal Delivery System
ALTO-101 transdermal delivery system
DRUG
Placebo
Inactive placebo patches
DEVICE
Placebo Transdermal Delivery System
Placebo transdermal delivery system
Primary outcome measures
Theta band activity
Time frame: Treatment Period 1 - Day 6 and Day 11; Treatment Period 2 - Day 6 and Day 11
Theta band activity after 5 and 10 days of dosing of ALTO-101T compared to placebo.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Garden Grove, California
- Los Angeles, California
- Orange, California
- Walnut Creek, California
- Hollywood, Florida
- Tampa, Florida
- Snellville, Georgia
- Chicago, Illinois
- Gaithersburg, Maryland
- Belmont, Massachusetts
- New York, New York
- White Plains, New York
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Dec 26, 2025 · Source of record for eligibility and locations