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
This trial does not accept healthy volunteersQualifiers
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
Design model
Crossover
Treatments tested in this trial
ALTO-101
DrugALTO-101 patches
ALTO-101 Transdermal Delivery System
DeviceALTO-101 transdermal delivery system
Placebo
DrugInactive placebo patches
Placebo Transdermal Delivery System
DevicePlacebo transdermal delivery system
Treatment groups
82 Participants
are divided into 2 treatment groupsGroup A: ALTO-101Experimental treatment 2 interventions
Group B: PlaceboPlacebo comparator 2 interventions
Trial outcomes
Primary outcomes
1
Theta band activity
Theta band activity after 5 and 10 days of dosing of ALTO-101T compared to placebo.
Time frame
Treatment Period 1 - Day 6 and Day 11; Treatment Period 2 - Day 6 and Day 11Secondary outcomes
1
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] ALTO-101T compared to placebo
Incidence, severity, and relatedness of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and discontinuation due to TEAEs.
Time frame
Treatment Period Day 1 through study completion (an average of 36 days)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov