Clinical trial NCT01163227: Effect of AQW051 on Cognitive Function in Patients With Chronic Stable Schizophrenia
Official title: A Randomized, Double-blind, Placebo-controlled, Cross-over, Single-dose Study to Evaluate the Effects of AQW051 on Cognitive Function in Patients With Chronic Stable Schizophrenia Including a One Week Multiple-dose Extension to Assess the Persistence of Observed Effects and a Multiple-dose Cross Over Study in Non Smokers Only.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Schizophrenia Disorders
Keywords: Hallucinations,
psychotic,
delusions,
cognitive deficits
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2010-07-15
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This PoC study is designed to assess the cognitive effects of doses of AQW051 in patients with chronic stable schizophrenia.


Eligibility criteria: Inclusion Criteria:

1. Diagnosis of schizophrenia
2. 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.
3. Specific cognitive impairment
4. Smokers and non-smokers

Exclusion Criteria:

1. 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.
2. Current treatment with conventional antipsychotics (e.g fluphenazine, haloperidol) or clozapine.
3. History of neuroleptic malignant syndrome.
4. Diagnosis of substance abuse (other than nicotine) within the last month and alcohol or substance dependence (other than nicotine) within the last 6 months.
5. Any clinically significant suicidal ideation (Type 4 or 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS) in the last month) or previous history of suicide behavior Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Effects of single oral doses of AQW051 versus placebo on cognitive function as measured by selected CogState tests
timeFrame: 132 days Part A, 121 days Part B (screening to study completion)
Secondary outcomes:
measure: Effects of single oral doses of AQW051 versus placebo on cognitive function as measured by selected MATRICS Consensus Cognitive Battery (MCCB) tests
timeFrame: 132 days Part A, 121 days Part B (screening to study completion)
measure: Effects of multiple oral doses of AQW051 versus placebo on cognitive function as measured by selected CogState tests and selected MCCB tests
timeFrame: 132 days Part A, 121 days Part B (screening to study completion)
measure: Correlation of the cognitive domains measured by MCCB versus CogState
timeFrame: 132 days Part A, 121 days Part B (screening to study completion)
measure: Pharmacokinetics, safety and tolerability of single and multiple doses of AQW051 as compared to placebo
timeFrame: 132 days Part A, 121 days Part B (screening to study completion)
Other outcomes:
Locations:
city: Glendale
country: United States
facility: PAREXEL (California Clinical Trials Medical Group), 1560 Chevy Chase Drive, Suite 140,
state: California
city: Willingboro
country: United States
facility: CRI Worldwide, 1113 Hospital Dr. Suite 202,
state: New Jersey
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: