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

Novartis

Status and phase: Completed; Phase 2

Conditions: Schizophrenia Disorders

Treatments: Drug: AQW051 100mg (single dose), and 50mg (multiple doses); Drug: AQW051 2 mg (single and multiple doses); Drug: AQW051 15mg (single and multiple doses); Drug: Placebo (single and multiple doses)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01163227

CAQW051A2205

Details and patient eligibility

About

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

Enrollment: 57 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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57 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo (single and multiple doses)

AQW051 Dose 1

Experimental group

Treatment:

Drug: AQW051 2 mg (single and multiple doses)

AQW051 Dose 2

Experimental group

Treatment:

Drug: AQW051 15mg (single and multiple doses)

AQW051 Dose 3

Experimental group

Treatment:

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