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

NCT ID: NCT01730768

Last Updated: 2020-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

147 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2013-12-31

Brief Summary

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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).

Detailed Description

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Conditions

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Schizophrenia

Keywords

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schizophrenia, chronic stable schizophrenia, cognition, memory, visual learning, CogState

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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AQW051 10 mg/day

Two 5mg AQW051 capsules will be taken orally daily by patients from Day 1 until Day 84.

Group Type EXPERIMENTAL

AQW051

Intervention Type DRUG

Placebo to AQW051

Matching placebo administered orally.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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AQW051

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Garden Grove, California, United States

Site Status

Novartis Investigative Site

Glendale, California, United States

Site Status

Novartis Investigative Site

National City, California, United States

Site Status

Novartis Investigative Site

Oakland, California, United States

Site Status

Novartis Investigative Site

Pico Rivera, California, United States

Site Status

Novartis Investigative Site

San Diego, California, United States

Site Status

Novartis Investigative Site

Miramar, Florida, United States

Site Status

Novartis Investigative Site

Atlanta, Georgia, United States

Site Status

Novartis Investigative Site

Marlton, New Jersey, United States

Site Status

Novartis Investigative Site

Staten Island, New York, United States

Site Status

Novartis Investigative Site

Staten Island, New York, United States

Site Status

Novartis Investigative Site

Philadelphia, Pennsylvania, United States

Site Status

Novartis Investigative Site

Irving, Texas, United States

Site Status

Countries

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United States

Related Links

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https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=12903

Results for CAQW051A2207 from the Novartis Clinical Trials website

Other Identifiers

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CAQW051A2207

Identifier Type: -

Identifier Source: org_study_id