Study of ALTO-101 in Patients With Schizophrenia

Part of paid clinical trials in Garden Grove, California.

Sponsor
Alto Neuroscience
Study ID
NCT06502964
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
21 Years - 55 Years
Healthy Volunteers
Not accepted

Interventions

  • ALTO-101 — DRUG
    ALTO-101 patches
  • ALTO-101 Transdermal Delivery System — DEVICE
    ALTO-101 transdermal delivery system
  • Placebo — DRUG
    Inactive placebo patches
  • Placebo Transdermal Delivery System — DEVICE
    Placebo transdermal delivery system

Study Details

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.

Key Dates

Start date
Jun 11, 2024
Status verified
Dec 2025
Primary completion
Feb 28, 2026
Completion
Mar 31, 2026

Study Design

Enrollment
82 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: ALTO-101
    10 days administration of ALTO-101T transdermal delivery system
  • Placebo Comparator: Placebo
    10 days administration of placebo transdermal delivery system

Primary Outcome Measure

Theta band activity [ Time Frame: Treatment Period 1 - Day 6 and Day 11; Treatment Period 2 - Day 6 and Day 11 ]

Central Contacts

Locations (14)

FacilityCityStateZIPSite coordinators
Site 5038Garden GroveCalifornia92845
Clinical Operations Manager
Site 5063Los AngelesCalifornia90015
Clinical Operations Manager
Site 5106OrangeCalifornia92868
Clinical Operations Manager
Site 5035Walnut CreekCalifornia94596
Clinical Operations Manager
Site 5060HollywoodFlorida33024
Clinical Operations Manager
Site 5015TampaFlorida33629-
Site 5064SnellvilleGeorgia30078
Clinical Operations Manager
Site 5056ChicagoIllinois60640
Clinical Operations Manager
Site 5062GaithersburgMaryland20877
Clinical Operations Manager
Site 5124BelmontMassachusetts02478
Clinical Operations Manager
Site 5077New YorkNew York10032
Clinical Operations Manager
Site 5108New YorkNew York10027
Clinical Operations Manager
Site 5109New YorkNew York10035-
Site 5126White PlainsNew York10605
Clinical Operations Manager

Find similar trials in Garden Grove, CA

By condition
Schizophrenia
By specialty
PsychiatryMental healthBehavioral health
By research site
Site 5038· Garden Grove, CASite 5063· Los Angeles, CASite 5106· Orange, CASite 5035· Walnut Creek, CASite 5060· Hollywood, FLSite 5015· Tampa, FL

Related Studies