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

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

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 Overview

• Status: Completed
• Conditions: Schizophrenia
• Intervention / Treatment: Drug: Placebo; Drug: AQW051

• Study Type: Interventional
• Enrollment (Actual): 147
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Garden Grove, California, United States, 92845
      • Novartis Investigative Site
    • Glendale, California, United States, 91206
      • Novartis Investigative Site
    • National City, California, United States, 91950
      • Novartis Investigative Site
    • Oakland, California, United States, 94612
      • Novartis Investigative Site
    • Pico Rivera, California, United States, 90660
      • Novartis Investigative Site
    • San Diego, California, United States, 92102
      • Novartis Investigative Site
  • Florida
    • Miramar, Florida, United States, 33025
      • Novartis Investigative Site
  • Georgia
    • Atlanta, Georgia, United States, 30308
      • Novartis Investigative Site
  • New Jersey
    • Marlton, New Jersey, United States, 08053
      • Novartis Investigative Site
  • New York
    • Staten Island, New York, United States, 10312
      • Novartis Investigative Site
    • Staten Island, New York, United States, 10305
      • Novartis Investigative Site
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19131
      • Novartis Investigative Site
  • Texas
    • Irving, Texas, United States, 75062
      • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AQW051 10 mg/day; Two 5mg AQW051 capsules will be taken orally daily by patients from Day 1 until Day 84.	Drug: AQW051
Placebo Comparator: Placebo to AQW051; Matching placebo administered orally.	Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals

Publications and helpful links

Helpful Links

• Results for CAQW051A2207 from the Novartis Clinical Trials website

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: September 6, 2012
• First Submitted That Met QC Criteria: November 20, 2012
• First Posted (Estimate): November 21, 2012

Study Record Updates

• Last Update Posted (Actual): December 24, 2020
• Last Update Submitted That Met QC Criteria: December 16, 2020
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: schizophrenia, chronic stable schizophrenia, cognition, memory, visual learning, CogState
• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia
• Other Study ID Numbers: CAQW051A2207