NCT06502964

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
82

participants targeted

Target at P25-P50 for phase_2 schizophrenia

Timeline
Completed

Started Jun 2024

Geographic Reach
1 country

14 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 11, 2024

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

July 9, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 16, 2024

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2026

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

December 26, 2025

Status Verified

December 1, 2025

Enrollment Period

1.6 years

First QC Date

July 9, 2024

Last Update Submit

December 23, 2025

Conditions

SchizophreniaCognitive Impairment

Outcome Measures

Primary Outcomes (1)

  • Theta band activity

    Theta band activity after 5 and 10 days of dosing of ALTO-101T compared to placebo.

    Treatment Period 1 - Day 6 and Day 11; Treatment Period 2 - Day 6 and Day 11

Secondary Outcomes (1)

  • Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] ALTO-101T compared to placebo

    Treatment Period Day 1 through study completion (an average of 36 days)

Study Arms (2)

ALTO-101

EXPERIMENTAL

10 days administration of ALTO-101T transdermal delivery system

Drug: ALTO-101Device: ALTO-101 Transdermal Delivery System

Placebo

PLACEBO COMPARATOR

10 days administration of placebo transdermal delivery system

Drug: PlaceboDevice: Placebo Transdermal Delivery System

Interventions

ALTO-101DRUG

ALTO-101 patches

ALTO-101
ALTO-101 Transdermal Delivery SystemDEVICE

ALTO-101 transdermal delivery system

ALTO-101
PlaceboDRUG

Inactive placebo patches

Placebo
Placebo Transdermal Delivery SystemDEVICE

Placebo transdermal delivery system

Placebo

Eligibility Criteria

Age21 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Site 5038

Garden Grove, California, 92845, United States

RECRUITING

Site 5063

Los Angeles, California, 90015, United States

RECRUITING

Site 5106

Orange, California, 92868, United States

RECRUITING

Site 5035

Walnut Creek, California, 94596, United States

RECRUITING

Site 5060

Hollywood, Florida, 33024, United States

RECRUITING

Site 5015

Tampa, Florida, 33629, United States

RECRUITING

Site 5064

Snellville, Georgia, 30078, United States

RECRUITING

Site 5056

Chicago, Illinois, 60640, United States

RECRUITING

Site 5062

Gaithersburg, Maryland, 20877, United States

RECRUITING

Site 5124

Belmont, Massachusetts, 02478, United States

RECRUITING

Site 5108

New York, New York, 10027, United States

RECRUITING

Site 5077

New York, New York, 10032, United States

RECRUITING

Site 5109

New York, New York, 10035, United States

WITHDRAWN

Site 5126

White Plains, New York, 10605, United States

RECRUITING

MeSH Terms

Conditions

SchizophreniaCognitive Dysfunction

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersCognition DisordersNeurocognitive Disorders

Central Study Contacts

Alto Neuroscience

CONTACT

650-200-0412clinical@altoneuroscience.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: Each participant will receive both placebo and active study drug: 10-day administration each of placebo TDS and ALTO-101T TDS (in random order), with a 6- to 14-day washout period between conditions.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 9, 2024

First Posted

July 16, 2024

Study Start

June 11, 2024

Primary Completion

February 1, 2026

Study Completion

March 1, 2026

Last Updated

December 26, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

US(14)