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

Completed · Phase 2 · Has a placebo group

Conditions studied: Schizophrenia

In brief

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).

Key facts

Study ID

NCT01730768

Run by

Novartis Pharmaceuticals

People needed

147

Starts

2012-09-01

Expected to finish

2013-12-01

Last updated by the study team

2020-12-24

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Novartis Investigative Site — Garden Grove, California, United States
• Novartis Investigative Site — Glendale, California, United States
• Novartis Investigative Site — National City, California, United States
• Novartis Investigative Site — Oakland, California, United States
• Novartis Investigative Site — Pico Rivera, California, United States
• Novartis Investigative Site — San Diego, California, United States
• Novartis Investigative Site — Miramar, Florida, United States
• Novartis Investigative Site — Atlanta, Georgia, United States
• Novartis Investigative Site — Marlton, New Jersey, United States
• Novartis Investigative Site — Staten Island, New York, United States
• Novartis Investigative Site — Staten Island, New York, United States
• Novartis Investigative Site — Philadelphia, Pennsylvania, United States
• Novartis Investigative Site — Irving, Texas, United States

Full record on ClinicalTrials.gov

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