A Study to Evaluate the Effects of Once Daily Doses of AQW051 on Cognition, in Stable Schizophrenia Patients

Phase 2

Completed

Brief Summary: This is a study in chronic stable Schizophrenia with the purpose to answer the question of whether agonism of the nicotinic alpha7 receptor is capable of enhancing cognition in a well defined chronic stable patient population treated with antipsychotics as standard of care, and thus to support the future development of AQW051 for the treatment of cognitive impairment associated with Schizophrenia (CIAS).

Recruitment & Eligibility

Inclusion Criteria

Diagnosis of schizophrenia
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.
Specific cognitive impairment
Smokers and non-smokers

Exclusion Criteria

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.
Current treatment with conventional antipsychotics (e.g fluphenazine, haloperidol) or clozapine.
History of neuroleptic malignant syndrome.
Diagnosis of substance abuse (other than nicotine) within the last month and alcohol or substance dependence (other than nicotine) within the last 6 months.
Score 4 or 5 on the Suicidal Ideation item or any "yes" on the Suicidal Behavior item of the CSSR-S that is related to suicidal behavior occurring during the last 2 years

Other protocol-defined inclusion/exclusion criteria may apply

Arm && Interventions

Group	Intervention	Description
Placebo to AQW051	Placebo	Matching placebo administered orally.
AQW051 10 mg/day	AQW051	Two 5mg AQW051 capsules will be taken orally daily by patients from Day 1 until Day 84.

Primary Outcome Measures

Name	Time	Method
Visual learning and memory at 4 weeks	4 weeks	The primary objective is to evaluate the pro-cognitive effects of AQW051 in a chronic stable schizophrenic patient population at week 4 as measured by the absolute change from baseline in CPAL number of errors (CogState battery) at week 4.

Secondary Outcome Measures

Name	Time	Method
Effect on cognitive function after 12 weeks of treatment - CogState test battery.	Baseline, 12 weeks	Change from baseline will be analyzed using a mixed model for repeated measures, including baseline value as covariate, time (timepoint), treatment as fixed effects and treatment\*time interaction term and patient as random effect. Appropriate contrasts will be used to compare treatments at each timepoint.
Effect on cognitive function after 12 weeks of treatment - MCCB	Baseline, 12 weeks	Change from baseline will be analyzed using a mixed model for repeated measures, including baseline value as covariate, time (timepoint), treatment as fixed effects and treatment\*time interaction term and patient as random effect. Appropriate contrasts will be used to compare treatments at each timepoint.
Number of patients with adverse events	12 weeks	Summarized statistics on adverse events will be reported under categories such as total adverse events, serious adverse events and death.