ALTO-101 for Schizophrenia

Recruiting at 7 trial locations

Overseen By Alto Neuroscience

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2

Sponsor: Alto Neuroscience

Must be taking: Antipsychotics

Must not be taking: Mood stabilizers, Clozapine, Benzodiazepines

Disqualifiers: Unstable condition, Bipolar, Dementia, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 20 days

82 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires that you stay on a stable dose of 1-2 antipsychotic medications for at least 8 weeks before joining. However, you cannot participate if you are using mood stabilizers, clozapine, or daily benzodiazepines.

What data supports the effectiveness of the drug ALTO-101 for treating schizophrenia?

Research on similar drugs like aripiprazole and olanzapine shows they can improve symptoms and reduce hospitalizations in people with schizophrenia, suggesting that ALTO-101 might have similar benefits. ^{1 2 3 4 5}

What is the purpose of this trial?

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.

Eligibility Criteria

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.

Inclusion Criteria

Cognitive impairment

I have been diagnosed with schizophrenia for over a year.

I have been on 1 or 2 stable antipsychotic medications for at least 8 weeks.

Exclusion Criteria

I am currently experiencing a major depressive episode.

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

I have a health condition that is not stable.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ALTO-101T or placebo via transdermal delivery system for 10 days in each crossover period

20 days

Multiple visits for patch application and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

16 days

Treatment Details

Interventions

• ALTO-101

Trial Overview 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.

Participant Groups

Group I: ALTO-101 Experimental Treatment 2 Interventions

10 days administration of ALTO-101T transdermal delivery system

Group II: Placebo Placebo Group 2 Interventions

10 days administration of placebo transdermal delivery system

Who Is Running the Clinical Trial?

Alto Neuroscience

Lead Sponsor

Trials

11

Recruited

1,300+

Findings from Research

In a study of 16 patients with treatment-resistant schizophrenia, olanzapine treatment led to significant improvements in psychiatric symptoms, as measured by the Brief Psychiatric Rating Scale (BPRS) and Global Assessment Scale (GAS), over 16 weeks.

While 50% of the patients showed a positive response to olanzapine, there was an increase in dyskinetic movements after 4 weeks, indicating a potential side effect that needs monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Olanzapine for patients with treatment-resistant schizophrenia: a naturalistic case-series outcome study. Dursun, SM., Gardner, DM., Bird, DC., et al.[2018]

Individuals with schizophrenia treated with aripiprazole once monthly (AOM400) had a 40% lower risk of hospitalization compared to those treated with atypical oral antipsychotics, indicating greater efficacy in managing their condition.

AOM400 not only resulted in longer time to first hospitalization and shorter hospital stays but also led to significant cost savings of €1,717.9 per individual annually, highlighting its potential for reducing healthcare resource use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Healthcare resource use and costs reduction with aripiprazole once-monthly in schizophrenia: AMBITION, a real-world study. Sanchez-Gistau, V., Moreno, MJ., Gómez-Lus, S., et al.[2023]

The GiSAS trial is a large-scale, pragmatic randomized controlled trial comparing the effectiveness of haloperidol, olanzapine, and aripiprazole in treating schizophrenia, involving at least 260 patients over a one-year follow-up period.

The primary focus of the study is to assess tolerability through the onset of metabolic syndrome and effectiveness by measuring the discontinuation of antipsychotic monotherapy, providing valuable real-world data to guide clinical prescriptions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The GiSAS study: rationale and design of a pragmatic randomized controlled trial on aripiprazole, olanzapine and haloperidol in the long-term treatment of schizophrenia. Parabiaghi, A., D'Avanzo, B., Tettamanti, M., et al.[2018]

In a study of 428 patients with schizophrenia, early improvement in positive symptoms after one week of treatment with a long-acting injectable antipsychotic was linked to better chances of achieving social functional remission after 65 weeks.

Key predictors for social functional remission included a shorter duration of illness, higher baseline social functioning scores, and higher supervision scores, indicating that these factors may play a significant role in treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early Improvement of Psychiatric Symptoms with Long-Acting Injectable Antipsychotic Predicts Subsequent Social Functional Remission in Patients with Schizophrenia. Ohnishi, T., Wakamatsu, A., Kobayashi, H.[2022]

In a 6-month study involving patients with schizophrenia who switched from oral antipsychotics to aripiprazole once-monthly 400 mg, significant improvements were observed in clinical symptoms as measured by the Positive and Negative Syndrome Scale (PANSS) and Clinical Global Impression-Severity (CGI-S) scores.

By the end of the study, nearly half (49.0%) of the patients were classified as responders, indicating a substantial reduction in symptoms, which suggests that AOM 400 is an effective treatment option for managing schizophrenia in a community setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of aripiprazole once-monthly on symptoms of schizophrenia in patients switched from oral antipsychotics. Peters-Strickland, T., Zhao, C., Perry, PP., et al.[2017]

References

1. United States pubmed.ncbi.nlm.nih.gov

Olanzapine for patients with treatment-resistant schizophrenia: a naturalistic case-series outcome study. [2018]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Healthcare resource use and costs reduction with aripiprazole once-monthly in schizophrenia: AMBITION, a real-world study. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

The GiSAS study: rationale and design of a pragmatic randomized controlled trial on aripiprazole, olanzapine and haloperidol in the long-term treatment of schizophrenia. [2018]

4. New Zealand pubmed.ncbi.nlm.nih.gov

Early Improvement of Psychiatric Symptoms with Long-Acting Injectable Antipsychotic Predicts Subsequent Social Functional Remission in Patients with Schizophrenia. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Effects of aripiprazole once-monthly on symptoms of schizophrenia in patients switched from oral antipsychotics. [2017]