Study of ALTO-101 in Patients With Schizophrenia

NCT06502964 · tracked via the Priya Life Science USA tracker

Sponsor

Alto Neuroscience

Phase

Phase 2

Started

2024-06-11

Last updated

2025-12-26

Condition(s) studied

SchizophreniaCognitive Impairment

Investigational drug(s) / intervention(s)

ALTO-101ALTO-101 Transdermal Delivery SystemPlaceboPlacebo Transdermal Delivery System

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

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.

Eligibility

Sex

ALL

Min age

21 Years

Max age

55 Years

Healthy volunteers

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

Primary outcome measure(s)

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.

Trial sites (14)

Facility	City	Region	Status
Site 5038	Garden Grove	California	Recruiting
Site 5063	Los Angeles	California	Recruiting
Site 5106	Orange	California	Recruiting
Site 5035	Walnut Creek	California	Recruiting
Site 5060	Hollywood	Florida	Recruiting
Site 5015	Tampa	Florida	Recruiting
Site 5064	Snellville	Georgia	Recruiting
Site 5056	Chicago	Illinois	Recruiting
Site 5062	Gaithersburg	Maryland	Recruiting
Site 5124	Belmont	Massachusetts	Recruiting
Site 5108	New York	New York	Recruiting
Site 5077	New York	New York	Recruiting
Site 5109	New York	New York	Withdrawn
Site 5126	White Plains	New York	Recruiting

More Alto Neuroscience trials in the USA

Study of ALTO-300 in MDD Recruiting

ALTO-207 in Adults With Treatment-resistant Depression (TRD) Recruiting

ALTO-100 in Bipolar Disorder With Depression (BD-D) Recruiting

Other trials for the same condition

A Study of LTX-001 In Adult Participants With Acute Exacerbation of Schizophrenia Recruiting

Study of SPG302 in Adults With Schizophrenia Active, not recruiting

A Study of the Feasibility, Safety and Tolerability of Aticaprant as Adjunctive Treatment in Participants With Schizophrenia Recruiting

Study to Evaluate LB-102 for the Treatment of Adult Patients With Acute Schizophrenia Recruiting

Efficacy of NBI-1117568 in Preventing Relapse in Adults With Schizophrenia Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06502964 on ClinicalTrials.gov ↗ ← All trials in the USA