Back to resultsEffect of AQW051 on Cognitive Function in Patients With Chronic Stable Schizophrenia
Primary Purpose
Schizophrenia Disorders
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Placebo (single and multiple doses)
AQW051 2 mg (single and multiple doses)
AQW051 15mg (single and multiple doses)
AQW051 100mg (single dose), and 50mg (multiple doses)
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia Disorders focused on measuring Hallucinations,, psychotic,, delusions,, cognitive deficits
Eligibility Criteria
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
Sites / Locations
- PAREXEL (California Clinical Trials Medical Group), 1560 Chevy Chase Drive, Suite 140,
- CRI Worldwide, 1113 Hospital Dr. Suite 202,
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Placebo Comparator
Experimental
Experimental
Experimental
Arm Label
Placebo
AQW051 Dose 1
AQW051 Dose 2
AQW051 Dose 3
Arm Description
Outcomes
Primary Outcome Measures
Effects of single oral doses of AQW051 versus placebo on cognitive function as measured by selected CogState tests
Secondary Outcome Measures
Effects of single oral doses of AQW051 versus placebo on cognitive function as measured by selected MATRICS Consensus Cognitive Battery (MCCB) tests
Effects of multiple oral doses of AQW051 versus placebo on cognitive function as measured by selected CogState tests and selected MCCB tests
Correlation of the cognitive domains measured by MCCB versus CogState
Pharmacokinetics, safety and tolerability of single and multiple doses of AQW051 as compared to placebo
Full Information
NCT ID
NCT01163227
First Posted
July 12, 2010
Last Updated
December 16, 2020
Sponsor
Novartis Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT01163227
Brief Title
Effect of AQW051 on Cognitive Function in Patients With Chronic Stable Schizophrenia
Official 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.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals
4. Oversight
5. Study Description
Brief Summary
This PoC study is designed to assess the cognitive effects of doses of AQW051 in patients with chronic stable schizophrenia.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia Disorders
Keywords
Hallucinations,, psychotic,, delusions,, cognitive deficits
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
57 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
AQW051 Dose 1
Arm Type
Experimental
Arm Title
AQW051 Dose 2
Arm Type
Experimental
Arm Title
AQW051 Dose 3
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Placebo (single and multiple doses)
Intervention Type
Drug
Intervention Name(s)
AQW051 2 mg (single and multiple doses)
Intervention Type
Drug
Intervention Name(s)
AQW051 15mg (single and multiple doses)
Intervention Type
Drug
Intervention Name(s)
AQW051 100mg (single dose), and 50mg (multiple doses)
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
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)
Title
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)
Title
Correlation of the cognitive domains measured by MCCB versus CogState
Time Frame
132 days Part A, 121 days Part B (screening to study completion)
Title
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
PAREXEL (California Clinical Trials Medical Group), 1560 Chevy Chase Drive, Suite 140,
City
Glendale
State/Province
California
ZIP/Postal Code
91206
Country
United States
Facility Name
CRI Worldwide, 1113 Hospital Dr. Suite 202,
City
Willingboro
State/Province
New Jersey
ZIP/Postal Code
08046
Country
United States
12. IPD Sharing Statement
Links:
URL
https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=12543
Description
Results for CAQW051A2205 from the Novartis Clinical Trials website
Learn more about this trial
Effect of AQW051 on Cognitive Function in Patients With Chronic Stable Schizophrenia
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