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

Novartis Pharmaceuticals147 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

147

Conditions

Schizophrenia

Interventions

AQW051DRUG

PlaceboDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 Years

Medical Language ↔ Plain English

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

Locations (13)

Novartis Investigative Site

Garden Grove, California, United States

Novartis Investigative Site

Glendale, California, United States

Novartis Investigative Site

National City, California, United States

Outcomes

Primary Outcomes

Visual learning and memory at 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.

Time frame: 4 weeks

Secondary Outcomes

Effect on cognitive function after 12 weeks of treatment - CogState test battery.

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.

Time frame: Baseline, 12 weeks

Effect on cognitive function after 12 weeks of treatment - MCCB

Time frame: Baseline, 12 weeks

Number of patients with adverse events

Summarized statistics on adverse events will be reported under categories such as total adverse events, serious adverse events and death.

Time frame: 12 weeks

Data from ClinicalTrials.gov

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