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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ALTO-101 | Experimental | 10 days administration of ALTO-101T transdermal delivery system |
|
| Placebo | Placebo Comparator | 10 days administration of placebo transdermal delivery system |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALTO-101 | Drug | ALTO-101 patches |
| |
| ALTO-101 Transdermal Delivery System |
| Measure | Description | Time Frame |
|---|---|---|
| Theta band activity | Theta band activity after 5 and 10 days of dosing of ALTO-101T compared to placebo. | Treatment Period 1 - Day 6 and Day 11; Treatment Period 2 - Day 6 and Day 11 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Treatment Period Day 1 through study completion (an average of 36 days) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alto Neuroscience | Contact | 650-200-0412 | clinical@altoneuroscience.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site 5038 | Recruiting | Garden Grove | California | 92845 | United States |
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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.
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| Device |
ALTO-101 transdermal delivery system |
|
| Placebo | Drug | Inactive placebo patches |
|
| Placebo Transdermal Delivery System | Device | Placebo transdermal delivery system |
|
| Site 5063 | Recruiting | Los Angeles | California | 90015 | United States |
|
| Site 5106 | Recruiting | Orange | California | 92868 | United States |
|
| Site 5035 | Recruiting | Walnut Creek | California | 94596 | United States |
|
| Site 5060 | Recruiting | Hollywood | Florida | 33024 | United States |
|
| Site 5015 | Recruiting | Tampa | Florida | 33629 | United States |
| Site 5064 | Recruiting | Snellville | Georgia | 30078 | United States |
|
| Site 5056 | Recruiting | Chicago | Illinois | 60640 | United States |
|
| Site 5062 | Recruiting | Gaithersburg | Maryland | 20877 | United States |
|
| Site 5124 | Recruiting | Belmont | Massachusetts | 02478 | United States |
|
| Site 5108 | Recruiting | New York | New York | 10027 | United States |
|
| Site 5077 | Recruiting | New York | New York | 10032 | United States |
|
| Site 5109 | Withdrawn | New York | New York | 10035 | United States |
| Site 5126 | Recruiting | White Plains | New York | 10605 | United States |
|
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
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