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Completed

NCT Number: NCT01730768

A 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).

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Key information

Conditions

Schizophrenia Behavior Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders Spatial Behavior Spatial Learning

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Novartis Investigative Site, Garden Grove, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AQW051

Drug

Placebo

Drug

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Nov 21, 2012
Registry last updated
Dec 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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