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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01730768
First received: September 6, 2012
Last updated: July 8, 2014
Last verified: July 2014
  Purpose

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 Intervention Phase
Schizophrenia
Drug: AQW051
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Visual learning and memory at 4 weeks [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    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:
  • Effect on cognitive function after 12 weeks of treatment - CogState test battery. [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    Summarized statistics on adverse events will be reported under categories such as total adverse events, serious adverse events and death.


Enrollment: 147
Study Start Date: September 2012
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01730768

Locations
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, 10312
Novartis Investigative Site
Staten Island, New York, United States, 10305
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
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01730768     History of Changes
Other Study ID Numbers: CAQW051A2207
Study First Received: September 6, 2012
Last Updated: July 8, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
schizophrenia, chronic stable schizophrenia, cognition, memory, visual learning, CogState

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders

ClinicalTrials.gov processed this record on August 19, 2014