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

Schizophrenia Disorders Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01163227
• Other study ID #: CAQW051A2205
• Status: Completed
• Phase: Phase 2
• Start date: May 2010
• Est. completion date: September 2011

Study information

• Verified date: March 2013
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Schizophrenia
• Schizophrenia Disorders

Intervention

Drug:
• 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)

Locations

Country	Name	City	State
United States	PAREXEL (California Clinical Trials Medical Group), 1560 Chevy Chase Drive, Suite 140,	Glendale	California
United States	CRI Worldwide, 1113 Hospital Dr. Suite 202,	Willingboro	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	Correlation of the cognitive domains measured by MCCB versus CogState		132 days Part A, 121 days Part B (screening to study completion)
Secondary	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)

External Links

•   Results for CAQW051A2205 from the Novartis Clinical Trials website