Study of ALTO-101 in Patients With Schizophrenia (NCT06502964) | Clinical Trial Compass
RecruitingPhase 2
Study of ALTO-101 in Patients With Schizophrenia
United States82 participantsStarted 2024-06-11
Plain-language summary
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 participate
Age range
21 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Theta band activity
Timeframe: Treatment Period 1 - Day 6 and Day 11; Treatment Period 2 - Day 6 and Day 11