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Study of ALTO-101 in Patients With Schizophrenia
Sponsor: Alto Neuroscience
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.
Official title: Double-Blind, Placebo-Controlled Study of ALTO-101 in Patients With Schizophrenia and Cognitive Impairment
Key Details
Gender
All
Age Range
21 Years - 55 Years
Study Type
INTERVENTIONAL
Enrollment
82
Start Date
2024-06-11
Completion Date
2026-03
Last Updated
2025-12-26
Healthy Volunteers
No
Conditions
Interventions
ALTO-101
ALTO-101 patches
ALTO-101 Transdermal Delivery System
ALTO-101 transdermal delivery system
Placebo
Inactive placebo patches
Placebo Transdermal Delivery System
Placebo transdermal delivery system
Locations (14)
Site 5038
Garden Grove, California, United States
Site 5063
Los Angeles, California, United States
Site 5106
Orange, California, United States
Site 5035
Walnut Creek, California, United States
Site 5060
Hollywood, Florida, United States
Site 5015
Tampa, Florida, United States
Site 5064
Snellville, Georgia, United States
Site 5056
Chicago, Illinois, United States
Site 5062
Gaithersburg, Maryland, United States
Site 5124
Belmont, Massachusetts, United States
Site 5108
New York, New York, United States
Site 5077
New York, New York, United States
Site 5109
New York, New York, United States
Site 5126
White Plains, New York, United States