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

NCT ID: NCT01163227

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

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2011-09-30

Brief Summary

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

Detailed Description

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Conditions

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Schizophrenia Disorders

Keywords

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Hallucinations, psychotic, delusions, cognitive deficits

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo

Group Type PLACEBO_COMPARATOR

Placebo (single and multiple doses)

Intervention Type DRUG

AQW051 Dose 1

Group Type EXPERIMENTAL

AQW051 2 mg (single and multiple doses)

Intervention Type DRUG

AQW051 Dose 2

Group Type EXPERIMENTAL

AQW051 15mg (single and multiple doses)

Intervention Type DRUG

AQW051 Dose 3

Group Type EXPERIMENTAL

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

Intervention Type DRUG

Interventions

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Placebo (single and multiple doses)

Intervention Type DRUG

AQW051 2 mg (single and multiple doses)

Intervention Type DRUG

AQW051 15mg (single and multiple doses)

Intervention Type DRUG

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Diagnosis of schizophrenia
2. 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.
3. Specific cognitive impairment
4. Smokers and non-smokers

Exclusion Criteria

1. 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.
2. Current treatment with conventional antipsychotics (e.g fluphenazine, haloperidol) or clozapine.
3. History of neuroleptic malignant syndrome.
4. Diagnosis of substance abuse (other than nicotine) within the last month and alcohol or substance dependence (other than nicotine) within the last 6 months.
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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PAREXEL (California Clinical Trials Medical Group), 1560 Chevy Chase Drive, Suite 140,

Glendale, California, United States

Site Status

CRI Worldwide, 1113 Hospital Dr. Suite 202,

Willingboro, New Jersey, 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=12543

Results for CAQW051A2205 from the Novartis Clinical Trials website

Other Identifiers

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CAQW051A2205

Identifier Type: -

Identifier Source: org_study_id