A Study to Evaluate the Effects of Once Daily Doses of AQW051 on Cognition, in Stable Schizophrenia Patients
| Status: | Completed |
|---|---|
| Conditions: | Schizophrenia |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 1/1/2014 |
| Start Date: | September 2012 |
| End Date: | December 2013 |
| Contact: | Novartis Pharmaceuticals |
| Phone: | 1-888-669-6682 |
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
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).
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).
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
We found this trial at
13
sites
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