Trials / Recruiting
RecruitingNCT06502964
Study of ALTO-101 in Patients With Schizophrenia
Double-Blind, Placebo-Controlled Study of ALTO-101 in Patients With Schizophrenia and Cognitive Impairment
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 82 (estimated)
- Sponsor
- Alto Neuroscience · Industry
- Sex
- All
- Age
- 21 Years – 55 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ALTO-101 | ALTO-101 patches |
| DEVICE | ALTO-101 Transdermal Delivery System | ALTO-101 transdermal delivery system |
| DRUG | Placebo | Inactive placebo patches |
| DEVICE | Placebo Transdermal Delivery System | Placebo transdermal delivery system |
Timeline
- Start date
- 2024-06-11
- Primary completion
- 2026-02-01
- Completion
- 2026-03-01
- First posted
- 2024-07-16
- Last updated
- 2025-12-26
Locations
14 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06502964. Inclusion in this directory is not an endorsement.