Clinical trial NCT01730768: A Study to Evaluate the Effects of Once Daily Doses of AQW051 on Cognition, in Stable Schizophrenia Patients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Schizophrenia
Keywords: schizophrenia, chronic stable schizophrenia, cognition, memory, visual learning, CogState
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2012-11-21
Enrollment: 147
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).


Eligibility 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

Primary outcomes:
measure: Visual learning and memory at 4 weeks
timeFrame: 4 weeks
Secondary outcomes:
measure: Effect on cognitive function after 12 weeks of treatment - CogState test battery.
timeFrame: Baseline, 12 weeks
measure: Effect on cognitive function after 12 weeks of treatment - MCCB
timeFrame: Baseline, 12 weeks
measure: Number of patients with adverse events
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Garden Grove
country: United States
facility: Novartis Investigative Site
state: California
city: Glendale
country: United States
facility: Novartis Investigative Site
state: California
city: National City
country: United States
facility: Novartis Investigative Site
state: California
city: Oakland
country: United States
facility: Novartis Investigative Site
state: California
city: Pico Rivera
country: United States
facility: Novartis Investigative Site
state: California
city: San Diego
country: United States
facility: Novartis Investigative Site
state: California
city: Miramar
country: United States
facility: Novartis Investigative Site
state: Florida
city: Atlanta
country: United States
facility: Novartis Investigative Site
state: Georgia
city: Marlton
country: United States
facility: Novartis Investigative Site
state: New Jersey
city: Staten Island
country: United States
facility: Novartis Investigative Site
state: New York
city: Staten Island
country: United States
facility: Novartis Investigative Site
state: New York
city: Philadelphia
country: United States
facility: Novartis Investigative Site
state: Pennsylvania
city: Irving
country: United States
facility: Novartis Investigative Site
state: Texas
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: