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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01730768
Recruitment Status : Completed
First Posted : November 21, 2012
Last Update Posted : December 24, 2020
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Description
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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).

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: AQW051 Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 147 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Study Start Date : September 2012
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Visual learning and memory at 4 weeks [ Time Frame: 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 :
  1. Effect on cognitive function after 12 weeks of treatment - CogState test battery. [ Time Frame: 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.

  2. Effect on cognitive function after 12 weeks of treatment - MCCB [ Time Frame: 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.

  3. Number of patients with adverse events [ Time Frame: 12 weeks ]
    Summarized statistics on adverse events will be reported under categories such as total adverse events, serious adverse events and death.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01730768


Locations
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United States, California
Novartis Investigative Site
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
United States, Florida
Novartis Investigative Site
Miramar, Florida, United States, 33025
United States, Georgia
Novartis Investigative Site
Atlanta, Georgia, United States, 30308
United States, New Jersey
Novartis Investigative Site
Marlton, New Jersey, United States, 08053
United States, New York
Novartis Investigative Site
Staten Island, New York, United States, 10305
Novartis Investigative Site
Staten Island, New York, United States, 10312
United States, Pennsylvania
Novartis Investigative Site
Philadelphia, Pennsylvania, United States, 19131
United States, Texas
Novartis Investigative Site
Irving, Texas, United States, 75062
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
More Information
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Additional Information:

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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01730768    
Other Study ID Numbers: CAQW051A2207
First Posted: November 21, 2012    Key Record Dates
Last Update Posted: December 24, 2020
Last Verified: March 2017
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
schizophrenia, chronic stable schizophrenia, cognition, memory, visual learning, CogState
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders