Study of ALTO-101 in Patients With Schizophrenia
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age21-55
SponsorAlto Neuroscience
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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)
Trial design
Treatments tested in this trial
- ALTO-101
- ALTO-101 Transdermal Delivery System
- Placebo
- Placebo Transdermal Delivery System
Treatment groups
82 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov