Study of ALTO-101 in Patients With Schizophrenia
Recruiting
Phase 2
Interventional Study
Schizophrenia
Cognitive Impairment
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 21 – 55
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 82 (estimated)
- Sponsor
- Alto Neuroscience · Industry
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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 p…
Trial Locations
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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 bod…
Contacts