ALTO-101 for Schizophrenia

Recruiting at 13 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new skin patch, ALTO-101, to determine if it can improve thinking skills in people with schizophrenia. Researchers aim to discover whether this patch, compared to a placebo, can alter brain activity related to thinking and enhance cognition. The trial also assesses the patch's safety and ease of use. Individuals who have had schizophrenia for at least a year, experience cognitive challenges, and are stable on their current medication might be suitable candidates for this trial. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

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.

Is there any evidence suggesting that ALTO-101T is likely to be safe for humans?

Research has shown that ALTO-101, administered through a skin patch, has been safe in earlier studies. In past trials, patients tolerated ALTO-101 well, and no major safety issues emerged. The skin patch method also improved the body's absorption of the drug, indicating good safety.

These findings suggest that ALTO-101 is well-tolerated, with no serious side effects reported in these early studies. While more research is needed, these results are encouraging for those considering participation in a trial for ALTO-101. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for schizophrenia?

Unlike the standard treatments for schizophrenia, which often involve oral medications and can take weeks to show effectiveness, ALTO-101 uses a transdermal delivery system, allowing the medication to be absorbed through the skin. This method promises faster absorption and potentially quicker symptom relief. Additionally, the unique delivery system might offer a more consistent release of medication, which could lead to fewer side effects and better adherence to treatment. Researchers are excited because these features could significantly improve the quality of life for individuals with schizophrenia.

What evidence suggests that ALTO-101 might be an effective treatment for schizophrenia?

Research has shown that ALTO-101, which participants in this trial may receive, might help improve cognitive problems in people with schizophrenia. This treatment appears promising because it targets specific brain markers related to cognition. The FDA has granted ALTO-101 a Fast Track designation, indicating its potential effectiveness. This designation suggests the treatment could make a meaningful difference, especially since it is designed as a skin patch. Researchers are carefully studying ALTO-101 in this trial to assess its ability to improve cognitive issues in schizophrenia. Early results suggest it could be a helpful tool for managing these challenges. ^{3 6 7 8 9}

Are You a Good Fit for This Trial?

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.

Willing to comply with all study assessments and procedures

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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]

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]

Citations

1. investors.altoneuroscience.com investors.altoneuroscience.com/news/news-details/2025/Alto-Neuroscience-Announces-Robust-Replication-of-EEG-Biomarker-to-Objectively-Identify-Patients-with-Cognitive-Impairment-in-Schizophrenia/default.aspx

Alto Neuroscience Announces Robust Replication of EEG ... Alto is currently utilizing theta ITC as a key biomarker and primary outcome measure in its ongoing Phase 2 study of ALTO-101, an ...

2. psychiatrictimes.com psychiatrictimes.com/view/alto-101-receives-fda-fast-track-designation-for-treatment-of-cognitive-impairment-related-to-schizophrenia

ALTO-101 Receives FDA Fast Track Designation for ... Alto Neuroscience's ALTO-101 gains FDA fast track designation, promising a novel treatment for cognitive impairment in schizophrenia.

3. neurologyadvisor.com neurologyadvisor.com/news/transdermal-pde4-inhibitor-fast-tracked-for-cognitive-impairment-in-schizophrenia/

Transdermal PDE4 Inhibitor Fast Tracked for Cognitive ... The FDA has granted Fast Track designation to ALTO-101 for the treatment of cognitive impairment associated with schizophrenia.

4. firstwordpharma.com firstwordpharma.com/story/5989085

Alto Neuroscience Reports Second Quarter 2025 Financial ... The Phase 2 POC trial consists of a dose-escalating treatment with ALTO-101 and is designed to enroll approximately 70 adult participants with ...

5. marketchameleon.com marketchameleon.com/articles/b/2025/10/3/fda-fast-track-for-alto-101-spotlights-alto-neurosciences-push-toward-a-novel-schizophrenia-treatment

FDA Fast Track for ALTO-101 Spotlights ... The FDA's Fast Track designation puts ALTO-101 on a quicker regulatory path, but meaningful results will hinge on upcoming data from the ongoing ...

6. investors.altoneuroscience.com investors.altoneuroscience.com/news/news-details/2025/Alto-Neuroscience-Receives-FDA-Fast-Track-Designation-for-ALTO-101-for-the-Treatment-of-Cognitive-Impairment-Associated-with-Schizophrenia/default.aspx

Alto Neuroscience Receives FDA Fast Track Designation ... Alto Neuroscience Receives FDA Fast Track Designation for ALTO-101 for the Treatment of Cognitive Impairment Associated with Schizophrenia.

7. clinicaltrialsarena.com clinicaltrialsarena.com/news/alto-alto-101-phase-i-results/

Alto Neuroscience reveals positive ALTO-101 Phase I trial ... Alto Neuroscience reported positive data from its Phase I trial of PDE4 inhibitor, ALTO-101, for cognitive impairment with schizophrenia.

8. trialx.com trialx.com/clinical-trials/listings/322491/study-of-alto-101-in-patients-with-schizophrenia/

Study of ALTO-101 in Patients With Schizophrenia This is a Phase 2, double-blind, placebo-controlled, two-way crossover study to compare the efficacy of ALTO-101T versus placebo in change ...

9. s204.q4cdn.com s204.q4cdn.com/951687249/files/doc_news/2024/Apr/23/alto-101-phase-1-patch-data-press-release-final.pdf

Alto Neuroscience Announces Positive Phase 1 Results for ... Results from the study demonstrated favorable tolerability and improved pharmacokinetics of ALTO-101 when administered via a transdermal ...