Effect of AQW051 on Cognitive Function in Patients With Chronic Stable Schizophrenia

A Randomized, Double-blind, Placebo-controlled, Cross-over, Single-dose Study to Evaluate the Effects of AQW051 on Cognitive Function in Patients With Chronic Stable Schizophrenia Including a One Week Multiple-dose Extension to Assess the Persistence of Observed Effects and a Multiple-dose Cross Over Study in Non Smokers Only.

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01163227

Enrollment

Registered

2010-07-15

Start date

2010-05-31

Completion date

2011-09-30

Last updated

2020-12-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia Disorders

Keywords

Hallucinations,, psychotic,, delusions,, cognitive deficits

Brief summary

This PoC study is designed to assess the cognitive effects of doses of AQW051 in patients with chronic stable schizophrenia.

Interventions

DRUGPlacebo (single and multiple doses)

DRUGAQW051 2 mg (single and multiple doses)

DRUGAQW051 15mg (single and multiple doses)

DRUGAQW051 100mg (single dose), and 50mg (multiple doses)

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Inclusion criteria

1. Diagnosis of schizophrenia 2. Symptomatically stable and currently treated with a stable regimen for at least 3 (three) months prior to dosing with one of the following second generation of antipsychotics: risperidone, paliperidone, quetiapine, ziprasidone, aripiprazole. 3. Specific cognitive impairment 4. Smokers and non-smokers

Exclusion criteria

1. Current treatment with an anticholinergic or other agent known to adversely interfere with the cholinergic system, and/ or treatment with cholinesterase inhibitor within the last three (3) months prior to dosing. 2. Current treatment with conventional antipsychotics (e.g fluphenazine, haloperidol) or clozapine. 3. History of neuroleptic malignant syndrome. 4. Diagnosis of substance abuse (other than nicotine) within the last month and alcohol or substance dependence (other than nicotine) within the last 6 months. 5. Any clinically significant suicidal ideation (Type 4 or 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS) in the last month) or previous history of suicide behavior Other protocol-defined inclusion/

Design outcomes

Primary

Measure	Time frame
Effects of single oral doses of AQW051 versus placebo on cognitive function as measured by selected CogState tests	132 days Part A, 121 days Part B (screening to study completion)

Secondary

Measure	Time frame
Effects of single oral doses of AQW051 versus placebo on cognitive function as measured by selected MATRICS Consensus Cognitive Battery (MCCB) tests	132 days Part A, 121 days Part B (screening to study completion)
Effects of multiple oral doses of AQW051 versus placebo on cognitive function as measured by selected CogState tests and selected MCCB tests	132 days Part A, 121 days Part B (screening to study completion)
Correlation of the cognitive domains measured by MCCB versus CogState	132 days Part A, 121 days Part B (screening to study completion)
Pharmacokinetics, safety and tolerability of single and multiple doses of AQW051 as compared to placebo	132 days Part A, 121 days Part B (screening to study completion)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026