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NCT06502964 · ClinicalTrials.gov registry record · Phase 2
Study of ALTO-101 in Patients With Schizophrenia
A Phase 2 study of Schizophrenia and Cognitive Impairment, sponsored by Alto Neuroscience.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 82
- Enrollment target
- 14
- Study locations
NCT06502964 is a Phase 2 study of Schizophrenia and Cognitive Impairment that is actively recruiting participants, run by Alto Neuroscience. The registered enrollment target is 82 participants, below the 219-participant average among 315 other Schizophrenia trials with a reported enrollment target (63% lower). The trial reports 14 study locations across 7 states.
The verdict
NCT06502964, a Phase 2 study of Schizophrenia and Cognitive Impairment, is actively recruiting participants, sponsored by Alto Neuroscience.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 82 participants
- Enrollment target
- 14
- Study locations
Study 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 Studied
Interventions
- DRUG Placebo
- DRUG ALTO-101
- DEVICE ALTO-101 Transdermal Delivery System
- DEVICE Placebo Transdermal Delivery System
Study Locations (14)
California
- Site 5038 - Garden Grove
- Site 5063 - Los Angeles
- Site 5106 - Orange
- Site 5035 - Walnut Creek
New York
- Site 5108 - New York
- Site 5077 - New York
- Site 5109 - New York
- Site 5126 - White Plains
Florida
- Site 5060 - Hollywood
- Site 5015 - Tampa
Georgia
- Site 5064 - Snellville
Illinois
- Site 5056 - Chicago
Maryland
- Site 5062 - Gaithersburg
Massachusetts
- Site 5124 - Belmont
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 82 participants |
| Start Date | 2024-06-11 |
| Est. Completion | 2026-03 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06502964
The ClinicalTrials.gov registry entry for NCT06502964 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 82 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 219-participant average among 315 other Schizophrenia trials with a reported enrollment target (63% lower). The listed sponsor is Alto Neuroscience, which has 10 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Schizophrenia appearing as the primary indexed condition, and to 4 interventions - of which Placebo is the first listed.
NCT06502964 reports 14 study locations spanning 7 distinct geographic areas - top geographies include California, New York, Florida.
Frequently Asked Questions
What is clinical trial NCT06502964 about?
NCT06502964 is a clinical study titled "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 in electroencephalogram (EEG) cognitive processing markers and measures of cognition. Additional goals are to assess pharmacokinetic (PK), safety, and tolerabil...
What is the current status of trial NCT06502964?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 82 participants. The study started on 2024-06-11. Estimated completion is 2026-03.
What conditions does trial NCT06502964 study?
This clinical trial studies the following conditions: Schizophrenia, Cognitive Impairment.
What interventions are being tested in trial NCT06502964?
The interventions under investigation include: Placebo (DRUG), ALTO-101 (DRUG), ALTO-101 Transdermal Delivery System (DEVICE), Placebo Transdermal Delivery System (DEVICE).
Who is sponsoring clinical trial NCT06502964?
This trial is sponsored by Alto Neuroscience, which has 10 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06502964 being conducted?
This trial has 14 study locations across California, Florida, Georgia, Illinois, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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