<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01730768</url>
  </required_header>
  <id_info>
    <org_study_id>CAQW051A2207</org_study_id>
    <nct_id>NCT01730768</nct_id>
  </id_info>
  <brief_title>A Study to Evaluate the Effects of Once Daily Doses of AQW051 on Cognition, in Stable Schizophrenia Patients</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Novartis Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Novartis</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a study in chronic stable Schizophrenia with the purpose to answer the question of&#xD;
      whether agonism of the nicotinic alpha7 receptor is capable of enhancing cognition in a well&#xD;
      defined chronic stable patient population treated with antipsychotics as standard of care,&#xD;
      and thus to support the future development of AQW051 for the treatment of cognitive&#xD;
      impairment associated with Schizophrenia (CIAS).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">December 2013</completion_date>
  <primary_completion_date type="Actual">December 2013</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Visual learning and memory at 4 weeks</measure>
    <time_frame>4 weeks</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Effect on cognitive function after 12 weeks of treatment - CogState test battery.</measure>
    <time_frame>Baseline, 12 weeks</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effect on cognitive function after 12 weeks of treatment - MCCB</measure>
    <time_frame>Baseline, 12 weeks</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with adverse events</measure>
    <time_frame>12 weeks</time_frame>
    <description>Summarized statistics on adverse events will be reported under categories such as total adverse events, serious adverse events and death.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">147</enrollment>
  <condition>Schizophrenia</condition>
  <arm_group>
    <arm_group_label>AQW051 10 mg/day</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Two 5mg AQW051 capsules will be taken orally daily by patients from Day 1 until Day 84.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo to AQW051</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Matching placebo administered orally.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>AQW051</intervention_name>
    <arm_group_label>AQW051 10 mg/day</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo to AQW051</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of schizophrenia&#xD;
&#xD;
          -  Symptomatically stable and currently treated with a stable regimen for at least 3&#xD;
             (three) months prior to dosing with one of the following second generation of&#xD;
             antipsychotics: risperidone, paliperidone, quetiapine, ziprasidone, aripiprazole.&#xD;
&#xD;
          -  Specific cognitive impairment&#xD;
&#xD;
          -  Smokers and non-smokers&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Current treatment with an anticholinergic or other agent known to adversely interfere&#xD;
             with the cholinergic system, and/ or treatment with cholinesterase inhibitor within&#xD;
             the last three (3) months prior to dosing.&#xD;
&#xD;
          -  Current treatment with conventional antipsychotics (e.g fluphenazine, haloperidol) or&#xD;
             clozapine.&#xD;
&#xD;
          -  History of neuroleptic malignant syndrome.&#xD;
&#xD;
          -  Diagnosis of substance abuse (other than nicotine) within the last month and alcohol&#xD;
             or substance dependence (other than nicotine) within the last 6 months.&#xD;
&#xD;
          -  Score 4 or 5 on the Suicidal Ideation item or any &quot;yes&quot; on the Suicidal Behavior item&#xD;
             of the CSSR-S that is related to suicidal behavior occurring during the last 2 years&#xD;
&#xD;
        Other protocol-defined inclusion/exclusion criteria may apply&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Novartis Pharmaceuticals</last_name>
    <role>Study Director</role>
    <affiliation>Novartis Pharmaceuticals</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Garden Grove</city>
        <state>California</state>
        <zip>92845</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Glendale</city>
        <state>California</state>
        <zip>91206</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>National City</city>
        <state>California</state>
        <zip>91950</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Oakland</city>
        <state>California</state>
        <zip>94612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Pico Rivera</city>
        <state>California</state>
        <zip>90660</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Miramar</city>
        <state>Florida</state>
        <zip>33025</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30308</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Marlton</city>
        <state>New Jersey</state>
        <zip>08053</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Staten Island</city>
        <state>New York</state>
        <zip>10305</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Staten Island</city>
        <state>New York</state>
        <zip>10312</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19131</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Irving</city>
        <state>Texas</state>
        <zip>75062</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=12903</url>
    <description>Results for CAQW051A2207 from the Novartis Clinical Trials website</description>
  </link>
  <verification_date>March 2017</verification_date>
  <study_first_submitted>September 6, 2012</study_first_submitted>
  <study_first_submitted_qc>November 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2012</study_first_posted>
  <disposition_first_submitted>August 20, 2020</disposition_first_submitted>
  <disposition_first_submitted_qc>August 20, 2020</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">August 26, 2020</disposition_first_posted>
  <last_update_submitted>December 16, 2020</last_update_submitted>
  <last_update_submitted_qc>December 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 24, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>schizophrenia, chronic stable schizophrenia, cognition, memory, visual learning, CogState</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Schizophrenia</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted, but a results disposition has been submitted           -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01730768
org study id: CAQW051A2207
nct id: NCT01730768
lead sponsor: 
has dmc: No
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).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Visual learning and memory at 4 weeks
time frame: 4 weeks
description: 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.
measure: Effect on cognitive function after 12 weeks of treatment - CogState test battery.
time frame: Baseline, 12 weeks
description: 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.
measure: Effect on cognitive function after 12 weeks of treatment - MCCB
time frame: Baseline, 12 weeks
description: 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.
measure: Number of patients with adverse events
time frame: 12 weeks
description: Summarized statistics on adverse events will be reported under categories such as total adverse events, serious adverse events and death.
arm group label: AQW051 10 mg/day
arm group type: Experimental
description: Two 5mg AQW051 capsules will be taken orally daily by patients from Day 1 until Day 84.
arm group label: Placebo to AQW051
arm group type: Placebo Comparator
description: Matching placebo administered orally.
intervention type: Drug
intervention name: AQW051
arm group label: AQW051 10 mg/day
intervention type: Drug
intervention name: Placebo
arm group label: Placebo to AQW051
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: No
last name: Novartis Pharmaceuticals
role: Study Director
affiliation: Novartis Pharmaceuticals
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
url: https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=12903
description: Results for CAQW051A2207 from the Novartis Clinical Trials website
responsible party type: Sponsor
mesh term: Schizophrenia