ALTO-101 for Schizophrenia

Phase 2

Recruiting

Research Sponsored by Alto Neuroscience

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Schizophrenia diagnosis for at least one year

Be between 18 and 65 years old

Must not have

Current episode of major depressive disorder (MDD)

Diagnosis of schizoaffective or bipolar affective disorder, dementia, or intellectual disability

Timeline

Screening 3 weeks

Treatment Varies

Follow Up treatment period 1 - day 6 and day 11; treatment period 2 - day 6 and day 11

Summary

This trial aims to compare the effectiveness of ALTO-101T versus a placebo in improving cognitive processing and cognition using EEG markers. It is a Phase 2 study involving a transdermal delivery system

Who is the study for?

This trial is for individuals with schizophrenia, particularly those experiencing cognitive impairment. Participants should meet specific health criteria and not have conditions that could interfere with the study or pose a risk.

What is being tested?

The study tests ALTO-101 delivered through the skin (transdermal) against a placebo to see if it improves brain function markers and cognition in schizophrenia patients. It's also checking how the body processes the drug and its safety.

What are the potential side effects?

While specific side effects are not listed, common concerns may include skin irritation at the patch site, potential neurological effects due to medication action on brain function, and general reactions like nausea or headaches.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with schizophrenia for over a year.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently experiencing a major depressive episode.

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I have been diagnosed with schizoaffective, bipolar disorder, dementia, or intellectual disability.

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I have a health condition that is not stable.

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I have not been hospitalized for psychiatric reasons in the last 6 months.

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I am currently taking medication for mood stabilization, clozapine, or daily benzodiazepine.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ treatment period 1 - day 6 and day 11; treatment period 2 - day 6 and day 11

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~treatment period 1 - day 6 and day 11; treatment period 2 - day 6 and day 11

This trial's timeline: 3 weeks for screening, Varies for treatment, and treatment period 1 - day 6 and day 11; treatment period 2 - day 6 and day 11 for reporting.