Effect of AQW051 on Cognitive Function in Patients With Chronic Stable Schizophrenia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01163227
First received: July 12, 2010
Last updated: March 6, 2013
Last verified: March 2013
  Purpose

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


Condition Intervention Phase
Schizophrenia Disorders
Drug: Placebo (single and multiple doses)
Drug: AQW051 2 mg (single and multiple doses)
Drug: AQW051 15mg (single and multiple doses)
Drug: AQW051 100mg (single dose), and 50mg (multiple doses)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Effects of single oral doses of AQW051 versus placebo on cognitive function as measured by selected CogState tests [ Time Frame: 132 days Part A, 121 days Part B (screening to study completion) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Effects of single oral doses of AQW051 versus placebo on cognitive function as measured by selected MATRICS Consensus Cognitive Battery (MCCB) tests [ Time Frame: 132 days Part A, 121 days Part B (screening to study completion) ] [ Designated as safety issue: No ]
  • Effects of multiple oral doses of AQW051 versus placebo on cognitive function as measured by selected CogState tests and selected MCCB tests [ Time Frame: 132 days Part A, 121 days Part B (screening to study completion) ] [ Designated as safety issue: No ]
  • Correlation of the cognitive domains measured by MCCB versus CogState [ Time Frame: 132 days Part A, 121 days Part B (screening to study completion) ] [ Designated as safety issue: No ]
  • Pharmacokinetics, safety and tolerability of single and multiple doses of AQW051 as compared to placebo [ Time Frame: 132 days Part A, 121 days Part B (screening to study completion) ] [ Designated as safety issue: Yes ]

Enrollment: 57
Study Start Date: May 2010
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: Placebo (single and multiple doses)
Experimental: AQW051 Dose 1 Drug: AQW051 2 mg (single and multiple doses)
Experimental: AQW051 Dose 2 Drug: AQW051 15mg (single and multiple doses)
Experimental: AQW051 Dose 3 Drug: AQW051 100mg (single dose), and 50mg (multiple doses)

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01163227

Locations
United States, California
PAREXEL (California Clinical Trials Medical Group), 1560 Chevy Chase Drive, Suite 140,
Glendale, California, United States, 91206
United States, New Jersey
CRI Worldwide, 1113 Hospital Dr. Suite 202,
Willingboro, New Jersey, United States, 08046
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01163227     History of Changes
Other Study ID Numbers: CAQW051A2205
Study First Received: July 12, 2010
Last Updated: March 6, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
Hallucinations,
psychotic,
delusions,
cognitive deficits

Additional relevant MeSH terms:
Schizophrenia
Mental Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on October 30, 2014