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A Study to Evaluate the Effects of Once Daily Doses of AQW051 on Cognition, in Stable Schizophrenia Patients

Sponsor
Novartis Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT01730768
Collaborator
(none)
147
Enrollment
13
Locations
2
Arms
15
Duration (Months)
11.3
Patients Per Site
0.8
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
147 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
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 Start Date :
Sep 1, 2012
Actual Primary Completion Date :
Dec 1, 2013
Actual Study Completion Date :
Dec 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Experimental: AQW051 10 mg/day

Two 5mg AQW051 capsules will be taken orally daily by patients from Day 1 until Day 84.

Drug: AQW051
Placebo Comparator: Placebo to AQW051

Matching placebo administered orally.

Drug: Placebo

Outcome Measures

Primary Outcome Measures

  1. 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 Outcome Measures

  1. 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.

  2. 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.

  3. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 55 Years
Sexes Eligible for Study:
All
Accepts 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/exclusion criteria may apply

Contacts and Locations

Locations

Site City State Country Postal Code
1 Novartis Investigative Site Garden Grove California United States 92845
2 Novartis Investigative Site Glendale California United States 91206
3 Novartis Investigative Site National City California United States 91950
4 Novartis Investigative Site Oakland California United States 94612
5 Novartis Investigative Site Pico Rivera California United States 90660
6 Novartis Investigative Site San Diego California United States 92102
7 Novartis Investigative Site Miramar Florida United States 33025
8 Novartis Investigative Site Atlanta Georgia United States 30308
9 Novartis Investigative Site Marlton New Jersey United States 08053
10 Novartis Investigative Site Staten Island New York United States 10305
11 Novartis Investigative Site Staten Island New York United States 10312
12 Novartis Investigative Site Philadelphia Pennsylvania United States 19131
13 Novartis Investigative Site Irving Texas United States 75062

Sponsors and Collaborators

  • Novartis Pharmaceuticals

Investigators

  • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01730768
Other Study ID Numbers:
  • CAQW051A2207
First Posted:
Nov 21, 2012
Last Update Posted:
Dec 24, 2020
Last Verified:
Mar 1, 2017
Keywords provided by Novartis Pharmaceuticals
schizophrenia, chronic stable schizophrenia, cognition, memory, visual learning, CogState
Additional relevant MeSH terms:
Schizophrenia

Study Results

No Results Posted as of Dec 24, 2020