Study of ALTO-101 in Patients With Schizophrenia

Alto Neuroscience

Status and phase: Enrolling; Phase 2

Conditions: Cognitive Impairment; Schizophrenia

Treatments: Drug: Placebo; Device: Placebo Transdermal Delivery System; Device: ALTO-101 Transdermal Delivery System; Drug: ALTO-101

Study type: Interventional

Funder types: Industry

Identifiers

NCT06502964

ALTO-101-201

Details and patient eligibility

About

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.

Enrollment: 82 estimated patients

Sex: All

Ages: 21 to 55 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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82 participants in 2 patient groups, including a placebo group

ALTO-101

Experimental group

Description:

10 days administration of ALTO-101T transdermal delivery system

Treatment:

Device: ALTO-101 Transdermal Delivery System

Drug: ALTO-101

Placebo

Placebo Comparator group

Description:

10 days administration of placebo transdermal delivery system

Treatment:

Device: Placebo Transdermal Delivery System

Drug: Placebo