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

Purpose

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).

Condition	Intervention	Phase
Schizophrenia	Drug: AQW051 Drug: Placebo	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	A 12 Week, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Effects of Once Daily Doses of AQW051 on Cognition, in Stable Schizophrenia Patients

Resource links provided by NLM:

MedlinePlus related topics: Memory Schizophrenia

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

Visual learning and memory at 4 weeks [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
The primary objective is to evaluate the pro-cognitive effects of AQW051 in a chronic stable schizophrenic patient population at week 4 as measured by the absolute change from baseline in CPAL number of errors (CogState battery) at week 4.

Secondary Outcome Measures:

Effect on cognitive function after 12 weeks of treatment - CogState test battery. [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: No ]
Change from baseline will be analyzed using a mixed model for repeated measures, including baseline value as covariate, time (timepoint), treatment as fixed effects and treatment*time interaction term and patient as random effect. Appropriate contrasts will be used to compare treatments at each timepoint.
Effect on cognitive function after 12 weeks of treatment - MCCB [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: No ]
Change from baseline will be analyzed using a mixed model for repeated measures, including baseline value as covariate, time (timepoint), treatment as fixed effects and treatment*time interaction term and patient as random effect. Appropriate contrasts will be used to compare treatments at each timepoint.
Number of patients with adverse events [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
Summarized statistics on adverse events will be reported under categories such as total adverse events, serious adverse events and death.

Estimated Enrollment:	134
Study Start Date:	September 2012
Estimated Study Completion Date:	June 2013
Estimated Primary Completion Date:	June 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: AQW051 10 mg/day Two 5mg AQW051 capsules will be taken orally daily by patients from Day 1 until Day 84.	Drug: AQW051
Placebo Comparator: Placebo to AQW051 Matching placebo administered orally.	Drug: Placebo

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01730768

Contacts

Contact: Novartis Pharmaceuticals

+1(862)778-8300

Locations

United States, California
Novartis Investigative Site	Recruiting
Garden Grove, California, United States, 92845
Novartis Investigative Site	Not yet recruiting
Garden Grove, California, United States, 92845
Novartis Investigative Site	Recruiting
Oakland, California, United States, 94612
Novartis Investigative Site	Not yet recruiting
Pico Rivera, California, United States, 90660
Novartis Investigative Site	Not yet recruiting
San Diego, California, United States, 92102

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

Study Director:

Novartis Pharmaceuticals

More Information

No publications provided

Responsible Party:	Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:	NCT01730768 History of Changes
Other Study ID Numbers:	CAQW051A2207
Study First Received:	September 6, 2012
Last Updated:	November 20, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

schizophrenia, chronic stable schizophrenia, cognition, memory, visual learning, CogState

Additional relevant MeSH terms:

Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders

ClinicalTrials.gov processed this record on May 21, 2013