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

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.

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

Study Overview

• Status: Completed
• Conditions: Schizophrenia Disorders
• Intervention / Treatment: Drug: Placebo (single and multiple doses); Drug: AQW051 2 mg (single and multiple doses); Drug: AQW051 15mg (single and multiple doses); Drug: AQW051 100mg (single dose), and 50mg (multiple doses)

• Study Type: Interventional
• Enrollment (Actual): 57
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Glendale, California, United States, 91206
      • PAREXEL (California Clinical Trials Medical Group), 1560 Chevy Chase Drive, Suite 140,
  • New Jersey
    • Willingboro, New Jersey, United States, 08046
      • CRI Worldwide, 1113 Hospital Dr. Suite 202,

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo (single and multiple doses)
Experimental: AQW051 Dose 1	Drug: AQW051 2 mg (single and multiple doses)
Experimental: AQW051 Dose 2	Drug: AQW051 15mg (single and multiple doses)
Experimental: AQW051 Dose 3	Drug: AQW051 100mg (single dose), and 50mg (multiple doses)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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)

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals

Publications and helpful links

Helpful Links

• Results for CAQW051A2205 from the Novartis Clinical Trials website

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (Actual): September 1, 2011
• Study Completion (Actual): September 1, 2011

Study Registration Dates

• First Submitted: July 12, 2010
• First Submitted That Met QC Criteria: July 14, 2010
• First Posted (Estimate): July 15, 2010

Study Record Updates

• Last Update Posted (Actual): December 24, 2020
• Last Update Submitted That Met QC Criteria: December 16, 2020
• Last Verified: March 1, 2013

More Information

Terms related to this study

• Keywords: cognitive deficits; Hallucinations,; psychotic,; delusions,
• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia
• Other Study ID Numbers: CAQW051A2205