Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT06502964 · ClinicalTrials.gov registry record · Phase 2
Study of ALTO-101 in Patients With Schizophrenia
A Phase 2 study of Schizophrenia and Cognitive Impairment, sponsored by Alto Neuroscience.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 82
- Enrollment target
- 14
- Study locations
NCT06502964: Recruiting Phase 2 study of Schizophrenia and Cognitive Impairment, sponsored by Alto Neuroscience.
NCT06502964 is a Phase 2 study of Schizophrenia and Cognitive Impairment that is actively recruiting participants, run by Alto Neuroscience. The registered enrollment target is 82 participants, below the 219-participant average among 315 other Schizophrenia trials with a reported enrollment target (63% lower). The trial reports 14 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06502964, a Phase 2 study of Schizophrenia and Cognitive Impairment, is actively recruiting participants, sponsored by Alto Neuroscience.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 82 participants
- Enrollment target
- 14
- Study locations
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.
Primary Outcome
Theta band activity after 5 and 10 days of dosing of ALTO-101T compared to placebo.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG ALTO-101
- DEVICE ALTO-101 Transdermal Delivery System
- DEVICE Placebo Transdermal Delivery System
Study Locations (14)
California
- Site 5038 - Garden Grove
- Site 5063 - Los Angeles
- Site 5106 - Orange
- Site 5035 - Walnut Creek
New York
- Site 5108 - New York
- Site 5077 - New York
- Site 5109 - New York
- Site 5126 - White Plains
Florida
- Site 5060 - Hollywood
- Site 5015 - Tampa
Georgia
- Site 5064 - Snellville
Illinois
- Site 5056 - Chicago
Maryland
- Site 5062 - Gaithersburg
Massachusetts
- Site 5124 - Belmont
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 82 participants |
| Start Date | 2024-06-11 |
| Est. Completion | 2026-03 |
| Phase | Phase 2 |
What NCT06502964 shows while recruiting
NCT06502964 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 82 participants, a relatively small participant target, below the 219-participant average among 315 other Schizophrenia trials with a reported enrollment target (63% lower).
The record links to 2 conditions, with Schizophrenia appearing as the primary indexed condition, and to 4 interventions - of which Placebo is the first listed.
NCT06502964 lists 14 locations in 7 states (California, New York, Florida).
Frequently Asked Questions
What is clinical trial NCT06502964 about?
NCT06502964 is a clinical study titled "Study of ALTO-101 in Patients With Schizophrenia". 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 tolerabil...
What is the current status of trial NCT06502964?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 82 participants. The study started on 2024-06-11. Estimated completion is 2026-03.
What conditions does trial NCT06502964 study?
This clinical trial studies the following conditions: Schizophrenia, Cognitive Impairment.
What interventions are being tested in trial NCT06502964?
The interventions under investigation include: Placebo (DRUG), ALTO-101 (DRUG), ALTO-101 Transdermal Delivery System (DEVICE), Placebo Transdermal Delivery System (DEVICE).
Who is sponsoring clinical trial NCT06502964?
This trial is sponsored by Alto Neuroscience, which has 10 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06502964 being conducted?
This trial has 14 study locations across California, Florida, Georgia, Illinois, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Schizophrenia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06502964's enrollment target sits among peer trials
82 159th of 315 higher than 157 of 315 other Schizophrenia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Schizophrenia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Search for Novel Transcranial Magnetic Stimulation (TMS) Targets for Mental Illness
RECRUITING · Phase 2
-
A Study to Assess the Efficacy and Safety of ML-007C-MA for the Treatment of Inpatient Adults With Schizophrenia
RECRUITING · Phase 2
-
Study to Assess the Safety, Tolerability, and Treatment Response of GXV813 in Hospitalized Adults With Schizophrenia
RECRUITING · Phase 2
-
A Study to Assess Adverse Events, Change in Disease Activity, and How Oral Emraclidine Moves Through the Body in Adult Participants With Schizophrenia
RECRUITING · Phase 2
-
Low-dose Buprenorphine as a Modulator of Social Motivation in Schizophrenia
RECRUITING · Phase 2
-
A Study of ANAVEX3-71 in Adults With Schizophrenia
ACTIVE NOT RECRUITING · Phase 2
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03319901 · 82 participants · Phase 1
Venetoclax and Chemotherapy as Frontline Therapy in Older Patients and Patients With Relapsed/Refractory ALL
- NCT03493425 · 82 participants · Phase 2
Chemotherapy Before Surgery and Radiation Therapy or Surgery and Radiation Therapy Alone in Treating Patients With Nasal and Paranasal Sinus Cancer That Can Be Removed by Surgery
- NCT04105270 · 82 participants · Phase 2
RMT in Combination With Durvalumab + Chemo in Untreated Adenocarcinoma NSCLC. A Randomized Double Blind Phase II Trial
- NCT04428658 · 82 participants · NA
Randomized Trial of Supplemental Synchronous and Asynchronous Telehealth to Improve Glycemic Control for Pediatric Patients With Type 1 Diabetes
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI