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

Phase 2

Completed

• Conditions: Schizophrenia Disorders
• Interventions: Drug: AQW051 15mg (single and multiple doses); Drug: AQW051 2 mg (single and multiple doses); Drug: Placebo (single and multiple doses); Drug: AQW051 100mg (single dose), and 50mg (multiple doses)

• Registration Number: NCT01163227
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05
• Study First Submitted: 2010-07-12
• Study First Submitted QC: 2010-07-14
• Study First Posted: 2010-07-15
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Disposition First Submitted: 2013-02-18
• Disposition First Submitted QC: 2013-02-18
• Disposition First Posted: 2013-02-22
• Status Verified: 2013-03
• Last Update Submitted: 2020-12-16
• Last Update Posted: 2020-12-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 57

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.
5. 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
AQW051 Dose 2	AQW051 15mg (single and multiple doses)	-
AQW051 Dose 1	AQW051 2 mg (single and multiple doses)	-
Placebo	Placebo (single and multiple doses)	-
AQW051 Dose 3	AQW051 100mg (single dose), and 50mg (multiple doses)	-

Primary Outcome Measures

Name	Time	Method
Effects of single oral doses of AQW051 versus placebo on cognitive function as measured by selected CogState tests	132 days Part A, 121 days Part B (screening to study completion)

Secondary Outcome Measures

Name	Time	Method
Effects of single oral doses of AQW051 versus placebo on cognitive function as measured by selected MATRICS Consensus Cognitive Battery (MCCB) tests	132 days Part A, 121 days Part B (screening to study completion)
Effects of multiple oral doses of AQW051 versus placebo on cognitive function as measured by selected CogState tests and selected MCCB tests	132 days Part A, 121 days Part B (screening to study completion)
Correlation of the cognitive domains measured by MCCB versus CogState	132 days Part A, 121 days Part B (screening to study completion)
Pharmacokinetics, safety and tolerability of single and multiple doses of AQW051 as compared to placebo	132 days Part A, 121 days Part B (screening to study completion)

Trial Locations

Locations (2)

CRI Worldwide, 1113 Hospital Dr. Suite 202,; 🇺🇸 Willingboro, New Jersey, United States

PAREXEL (California Clinical Trials Medical Group), 1560 Chevy Chase Drive, Suite 140,; 🇺🇸 Glendale, California, United States