Schizophrenia
Conditions
Keywords
schizophrenia, chronic stable schizophrenia, cognition, memory, visual learning, CogState
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).
Interventions
DRUGAQW051
DRUGPlacebo
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual learning and memory at 4 weeks | 4 weeks | 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
| Measure | Time frame | Description |
|---|---|---|
| Effect on cognitive function after 12 weeks of treatment - CogState test battery. | Baseline, 12 weeks | 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 | Baseline, 12 weeks | 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 | 12 weeks | Summarized statistics on adverse events will be reported under categories such as total adverse events, serious adverse events and death. |
Countries
United States
Outcome results
None listed