A Study to Evaluate the Effects of Once Daily Doses of AQW051 on Cognition, in Stable Schizophrenia Patients

Novartis

Status and phase: Completed; Phase 2

Conditions: Schizophrenia

Treatments: Drug: Placebo; Drug: AQW051

Study type: Interventional

Funder types: Industry

Identifiers

NCT01730768

CAQW051A2207

Details and patient eligibility

About

This is a study in chronic stable Schizophrenia with the purpose to answer the question of whether agonism of the nicotinic alpha7 receptor is capable of enhancing cognition in a well defined chronic stable patient population treated with antipsychotics as standard of care, and thus to support the future development of AQW051 for the treatment of cognitive impairment associated with Schizophrenia (CIAS).

Enrollment: 147 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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.
• Score 4 or 5 on the Suicidal Ideation item or any "yes" on the Suicidal Behavior item of the CSSR-S that is related to suicidal behavior occurring during the last 2 years

Other protocol-defined inclusion/exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

147 participants in 2 patient groups, including a placebo group

AQW051 10 mg/day

Experimental group

Description:

Two 5mg AQW051 capsules will be taken orally daily by patients from Day 1 until Day 84.

Treatment:

Drug: AQW051

Placebo to AQW051

Placebo Comparator group

Description:

Matching placebo administered orally.

Treatment:

Drug: Placebo