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Completed

NCT Number: NCT01163227

Effect of AQW051 on Cognitive Function in Patients With Chronic Stable Schizophrenia

This PoC study is designed to assess the cognitive effects of doses of AQW051 in patients with chronic stable schizophrenia.

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Key information

Conditions

Schizophrenia Disorders Behavior Behavioral Symptoms Cognition Disorders Delusions Hallucinations Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders Signs and Symptoms

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

PAREXEL (California Clinical Trials Medical Group), 1560 Chevy Chase Drive, Suite 140,, Glendale, 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.
  • Any clinically significant suicidal ideation (Type 4 or 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS) in the last month) or previous history of suicide behavior Other protocol-defined inclusion/exclusion criteria may apply

Treatment and study plan

Placebo (single and multiple doses)

Drug

AQW051 2 mg (single and multiple doses)

Drug

AQW051 15mg (single and multiple doses)

Drug

AQW051 100mg (single dose), and 50mg (multiple doses)

Drug

Primary outcomes

  1. Effects of single oral doses of AQW051 versus placebo on cognitive function as measured by selected CogState tests

    Time frame: 132 days Part A, 121 days Part B (screening to study completion)

Secondary outcomes

  1. Effects of single oral doses of AQW051 versus placebo on cognitive function as measured by selected MATRICS Consensus Cognitive Battery (MCCB) tests

    Time frame: 132 days Part A, 121 days Part B (screening to study completion)

  2. Effects of multiple oral doses of AQW051 versus placebo on cognitive function as measured by selected CogState tests and selected MCCB tests

    Time frame: 132 days Part A, 121 days Part B (screening to study completion)

  3. Correlation of the cognitive domains measured by MCCB versus CogState

    Time frame: 132 days Part A, 121 days Part B (screening to study completion)

  4. Pharmacokinetics, safety and tolerability of single and multiple doses of AQW051 as compared to placebo

    Time frame: 132 days Part A, 121 days Part B (screening to study completion)

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

A Randomized, Double-blind, Placebo-controlled, Cross-over, Single-dose Study to Evaluate the Effects of AQW051 on Cognitive Function in Patients With Chronic Stable Schizophrenia Including a One Week Multiple-dose Extension to Assess the Persistence of Observed Effects and a Multiple-dose Cross Over Study in Non Smokers Only.

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jul 15, 2010
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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