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

Schizophrenia Clinical Trial

Official title:

A 12 Week, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Effects of Once Daily Doses of AQW051 on Cognition, in Stable Schizophrenia Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01730768
• Other study ID #: CAQW051A2207
• Status: Completed
• Phase: Phase 2
• Start date: September 2012
• Est. completion date: December 2013

Study information

• Verified date: March 2017
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 information / eligibility

• Status: Completed
• Enrollment: 147
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

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

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• AQW051

• Placebo

Locations

Country	Name	City	State
United States	Novartis Investigative Site	Atlanta	Georgia
United States	Novartis Investigative Site	Garden Grove	California
United States	Novartis Investigative Site	Glendale	California
United States	Novartis Investigative Site	Irving	Texas
United States	Novartis Investigative Site	Marlton	New Jersey
United States	Novartis Investigative Site	Miramar	Florida
United States	Novartis Investigative Site	National City	California
United States	Novartis Investigative Site	Oakland	California
United States	Novartis Investigative Site	Philadelphia	Pennsylvania
United States	Novartis Investigative Site	Pico Rivera	California
United States	Novartis Investigative Site	San Diego	California
United States	Novartis Investigative Site	Staten Island	New York
United States	Novartis Investigative Site	Staten Island	New York

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	4 weeks
Secondary	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.	Baseline, 12 weeks
Secondary	Effect on cognitive function after 12 weeks of treatment - MCCB	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.	Baseline, 12 weeks
Secondary	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.	12 weeks

External Links

•   Results for CAQW051A2207 from the Novartis Clinical Trials website