Cognitive Impairment, Schizophrenia
Conditions
Brief 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. 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.
Interventions
DEVICEALTO-101 Transdermal Delivery System
ALTO-101 transdermal delivery system
DRUGPlacebo
Inactive placebo patches
DEVICEPlacebo Transdermal Delivery System
Placebo transdermal delivery system
DRUGALTO-101
ALTO-101 patches
Sponsors
Alto Neuroscience
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
21 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Theta band activity | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] ALTO-101T compared to placebo | Treatment Period Day 1 through study completion (an average of 36 days) | Incidence, severity, and relatedness of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and discontinuation due to TEAEs. |
Countries
United States
Contacts
Primary ContactAlto Neuroscience
Outcome results
None listed