Study of ALTO-101 in Patients With Schizophrenia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ALTO-101, ALTO-101 Transdermal Delivery System, Placebo, Placebo Transdermal Delivery System.
- Who it may be relevant to
- Registry conditions: Schizophrenia, Cognitive Impairment. Basic parameters: 21 years — 55 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Double-Blind, Placebo-Controlled Study of ALTO-101 in Patients With Schizophrenia and Cognitive Impairment
Overview
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.
Interventions
- Drug ALTO-101
ALTO-101 patches - Device ALTO-101 Transdermal Delivery System
ALTO-101 transdermal delivery system - Drug Placebo
Inactive placebo patches - Device Placebo Transdermal Delivery System
Placebo transdermal delivery system
Primary outcome measures
- Theta band activity [Time frame: Treatment Period 1 - Day 6 and Day 11; Treatment Period 2 - Day 6 and Day 11]
Secondary outcome measures (1)
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] ALTO-101T compared to placebo [Time frame: Treatment Period Day 1 through study completion (an average of 36 days)]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
United States · 14 centers
- Site 5038 — Garden Grove
- Site 5063 — Los Angeles
- Site 5106 — Orange
- Site 5035 — Walnut Creek
- Site 5060 — Hollywood
- Site 5015 — Tampa
- Site 5064 — Snellville
- Site 5056 — Chicago
- … and 6 more centers
Identifiers
NCT: NCT06502964 · ALTO-101-201