SchizophreniaPhase 2NCT06502964
Study of ALTO-101 in Patients With Schizophrenia
A Phase 2 study testing ALTO-101 and ALTO-101 Transdermal Delivery System in people with Schizophrenia and Cognitive Impairment, run by Alto Neuroscience at 14 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 55 years
- Conditions the study is for
- Schizophrenia, Cognitive Impairment
- What is being tested?
- ALTO-101 and ALTO-101 Transdermal Delivery System
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 82 participants
- Where
- 14 sitesUnited States
- Study dates
- 11 Jun 2024to Mar 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
14 sites in 1 country. Contact the study team or a site near you to ask about taking part.
14 sites in 1 country
United States14 sites, 13 recruiting
- Recruiting
Site 5124
Belmont, Massachusetts, 02478
Clinical Operations Manager
- Recruiting
Site 5056
Chicago, Illinois, 60640
Clinical Operations Manager
- Recruiting
Site 5062
Gaithersburg, Maryland, 20877
Clinical Operations Manager
- Recruiting
Site 5038
Garden Grove, California, 92845
Clinical Operations Manager
- Recruiting
Site 5060
Hollywood, Florida, 33024
Clinical Operations Manager
- Recruiting
Site 5063
Los Angeles, California, 90015
Clinical Operations Manager
- Recruiting
Site 5108
New York, New York, 10027
Clinical Operations Manager
- Recruiting
Site 5077
New York, New York, 10032
Clinical Operations Manager
- Withdrawn
Site 5109
New York, New York, 10035
- Recruiting
Site 5106
Orange, California, 92868
Clinical Operations Manager
- Recruiting
Site 5064
Snellville, Georgia, 30078
Clinical Operations Manager
- Recruiting
Site 5015
Tampa, Florida, 33629
- Recruiting
Site 5035
Walnut Creek, California, 94596
Clinical Operations Manager
- Recruiting
Site 5126
White Plains, New York, 10605
Clinical Operations Manager
About this study
Official title: Double-Blind, Placebo-Controlled Study of ALTO-101 in Patients With Schizophrenia and Cognitive Impairment
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
- Schizophrenia, Cognitive Impairment
- Being tested
- ALTO-101, ALTO-101 Transdermal Delivery System, Placebo, Placebo Transdermal Delivery System
- Medical subject headings
- Schizophrenia, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALTO-101Drug
ALTO-101 patches
ALTO-101 Transdermal Delivery SystemDevice
ALTO-101 transdermal delivery system
PlaceboDrug
Inactive placebo patches
Placebo Transdermal Delivery SystemDevice
Placebo transdermal delivery system
| Study group | Role | What they receive |
|---|---|---|
| ALTO-101 | Experimental | 10 days administration of ALTO-101T transdermal delivery system Receives: Drug: ALTO-101; Device: ALTO-101 Transdermal Delivery System |
| Placebo | Placebo comparator | 10 days administration of placebo transdermal delivery system Receives: Drug: Placebo; Device: Placebo Transdermal Delivery System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Theta band activity
Theta band activity after 5 and 10 days of dosing of ALTO-101T compared to placebo.
Measured: Treatment Period 1 - Day 6 and Day 11; Treatment Period 2 - Day 6 and Day 11
Secondary outcomes (1)
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] ALTO-101T compared to placebo
Incidence, severity, and relatedness of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and discontinuation due to TEAEs.
Measured: Treatment Period Day 1 through study completion (an average of 36 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2024
- Study start11 Jun 2024
- Primary completionFeb 2026 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Each participant will receive both placebo and active study drug: 10-day administration each of placebo TDS and ALTO-101T TDS (in random order), with a 6- to 14-day washout period between conditions.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alto Neuroscience
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06502964
- Sponsor's protocol ID
- ALTO-101-201
- Status last verified
- Dec 2025
- First submitted
- 9 Jul 2024
- Last updated
- 26 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-Blind, Placebo-Controlled Study of ALTO-101 in Patients With Schizophrenia and Cognitive Impairment
- ClinicalTrials.gov ID
- NCT06502964
- Acronym / sponsor ID
- ALTO-101-201
- Conditions
- Schizophrenia, Cognitive Impairment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Alto NeuroscienceIndustry (pharma, biotech, devices)
- Study start
- 11 Jun 2024 (actual)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 16 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Each participant will receive both placebo and active study drug: 10-day administration each of placebo TDS and ALTO-101T TDS (in random order), with a 6- to 14-day washout period between conditions.
| Arm | Type | Receives |
|---|---|---|
| ALTO-101 | Experimental | Drug: ALTO-101, Device: ALTO-101 Transdermal Delivery System10 days administration of ALTO-101T transdermal delivery system |
| Placebo | Placebo comparator | Drug: Placebo, Device: Placebo Transdermal Delivery System10 days administration of placebo transdermal delivery system |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ALTO-101ALTO-101 patches | Drug | ALTO-101 |
| ALTO-101 Transdermal Delivery SystemALTO-101 transdermal delivery system | Device | ALTO-101 |
| PlaceboInactive placebo patches | Drug | Placebo |
| Placebo Transdermal Delivery SystemPlacebo transdermal delivery system | Device | Placebo |
Primary outcome
Theta band activity
Time frame: Treatment Period 1 - Day 6 and Day 11; Treatment Period 2 - Day 6 and Day 11
Theta band activity after 5 and 10 days of dosing of ALTO-101T compared to placebo.
1 secondary outcome
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] ALTO-101T compared to placebo
Time frame: Treatment Period Day 1 through study completion (an average of 36 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ALTO-101 and ALTO-101 Transdermal Delivery System in people with Schizophrenia and Cognitive Impairment, run by Alto Neuroscience at 14 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alto Neuroscience (650-200-0412, clinical@altoneuroscience.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Theta band activity (time frame: Treatment Period 1 - Day 6 and Day 11; Treatment Period 2 - Day 6 and Day 11). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2025.