Actively Recruiting
Study of ALTO-101 in Patients With Schizophrenia
Led by Alto Neuroscience · Updated on 2025-12-26
82
Participants Needed
14
Research Sites
89 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Official Title
Study of ALTO-101 in Patients With Schizophrenia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of schizophrenia for at least one year
- Presence of cognitive impairment
- Stable doses of 1 to 2 antipsychotic medications for at least 8 weeks before Visit 2
- Positive and Negative Syndrome Scale (PANSS) scores with items P1, P3-P6 �3C= 5 and items P2 and P7 �3C= 4 during screening
- Body mass index (BMI) between 18.0 and 37.0 kg/m2 inclusive
- Willingness to comply with all study assessments and procedures
You will not qualify if you...
- Evidence of unstable medical condition
- Acute psychiatric decompensation or symptoms severe enough to require psychiatric hospitalization in past 6 months
- Diagnosis of schizoaffective disorder, bipolar affective disorder, dementia, or intellectual disability
- Current episode of major depressive disorder
- Use of mood stabilizers, clozapine, and/or daily benzodiazepines
- Current moderate or severe substance use disorder
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 14 locations
1
Site 5038
Garden Grove, California, United States, 92845
Actively Recruiting
2
Site 5063
Los Angeles, California, United States, 90015
Actively Recruiting
3
Site 5106
Orange, California, United States, 92868
Actively Recruiting
4
Site 5035
Walnut Creek, California, United States, 94596
Actively Recruiting
5
Site 5060
Hollywood, Florida, United States, 33024
Actively Recruiting
6
Site 5015
Tampa, Florida, United States, 33629
Actively Recruiting
7
Site 5064
Snellville, Georgia, United States, 30078
Actively Recruiting
8
Site 5056
Chicago, Illinois, United States, 60640
Actively Recruiting
9
Site 5062
Gaithersburg, Maryland, United States, 20877
Actively Recruiting
10
Site 5124
Belmont, Massachusetts, United States, 02478
Actively Recruiting
11
Site 5108
New York, New York, United States, 10027
Actively Recruiting
12
Site 5077
New York, New York, United States, 10032
Actively Recruiting
13
Site 5109
New York, New York, United States, 10035
Withdrawn
14
Site 5126
White Plains, New York, United States, 10605
Actively Recruiting
Research Team
A
Alto Neuroscience
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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