<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/NCT01678755</url>
  </required_header>
  <id_info>
    <org_study_id>M13-608</org_study_id>
    <nct_id>NCT01678755</nct_id>
  </id_info>
  <brief_title>A Phase 2 Study to Evaluate ABT-126 for the Treatment of Cognitive Deficits in Schizophrenia</brief_title>
  <official_title>A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2 Study of the Safety and Efficacy of ABT-126 in the Treatment of Cognitive Deficits in Schizophrenia (CDS) in Smokers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AbbVie (prior sponsor, Abbott)</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>AbbVie</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is an efficacy study evaluating a experimental treatment for cognitive deficits in&#xD;
      adults with schizophrenia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Safety and Efficacy Study for Cognitive Deficits in Adult Subjects with Schizophrenia.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">March 2014</completion_date>
  <primary_completion_date type="Actual">March 2014</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>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cognition: MCCB (MATRICS Consensus Cognitive Battery) change from baseline to week 12</measure>
    <time_frame>Change from baseline to week 12</time_frame>
    <description>Rater based interview</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Functioning: UPSA-2 (University of California San Diego Performance-based Skills Assessment-2)</measure>
    <time_frame>Measurements from screening period up through week 12</time_frame>
    <description>Rater based interview</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Symptom Severity: PANSS (Positive and Negative Syndrome Scale)</measure>
    <time_frame>Measurements from screening period up through week 12</time_frame>
    <description>Rater based interview</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Symptom Severity: NSA-16 (16-item version of the Negative Symptom Assessment Scale)</measure>
    <time_frame>Measurements from screening period up through week 12</time_frame>
    <description>Rater based interview</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">157</enrollment>
  <condition>Schizophrenia</condition>
  <arm_group>
    <arm_group_label>ABT-126 Low Dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ABT-126 Low Dose</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ABT-126 High Dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ABT-126 High Dose</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ABT-126</intervention_name>
    <description>ABT-126 Low Dose</description>
    <arm_group_label>ABT-126 Low Dose</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ABT-126</intervention_name>
    <description>ABT-126 High Dose</description>
    <arm_group_label>ABT-126 High Dose</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Has a current Diagnostic and Statistical Manual of Mental Disorders-, 4th Edition,&#xD;
             Text Revision (DSM-IV-TR) diagnosis of schizophrenia confirmed by the&#xD;
             Mini-International Neuropsychiatric Interview (M.I.N.I.).&#xD;
&#xD;
          -  Is clinically stable while receiving a regimen of one or two allowable antipsychotic&#xD;
             medications; lack of hospitalizations in 4 months prior to initial screening visit;&#xD;
             taking the same antipsychotic medication(s) for at least 8 weeks prior to baseline&#xD;
             visit; core positive symptoms of Positive and Negative Syndrome Scale (PANSS) no worse&#xD;
             than moderate in severity throughout screening period of at least 4 weeks.&#xD;
&#xD;
          -  Has been diagnosed with or treated for schizophrenia for at least 2 years prior to&#xD;
             initial screening visit.&#xD;
&#xD;
          -  Has had continuity in psychiatric care (e.g., mental health system, clinic or&#xD;
             physician) for at least 6 months prior to initial screening visit.&#xD;
&#xD;
          -  Has an identified contact person (e.g., family member, social worker, case worker, or&#xD;
             nurse) that can provide support to the subject to ensure compliance with protocol&#xD;
             requirements.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  In the Investigator's judgment, has a current or past diagnosis of schizoaffective&#xD;
             disorder, bipolar disorder, manic episode, dementia, post traumatic stress disorder,&#xD;
             or obsessive-compulsive disorder, or the subject has a current major depressive&#xD;
             episode.&#xD;
&#xD;
          -  Has a positive urine drug screen for cocaine, phencyclidine (PCP), opiates (unless&#xD;
             duly prescribed), benzodiazepines (unless duly prescribed), marijuana, or amphetamines&#xD;
             during the Screening Period.&#xD;
&#xD;
          -  Has a current or past history of seizures, with the exception of a single febrile&#xD;
             seizure occurring prior to 6 years of age.&#xD;
&#xD;
          -  Has a clinically significant abnormal electrocardiogram (ECG) at Screening Visit 1 as&#xD;
             determined by the Investigator.&#xD;
&#xD;
          -  Has any risk factors for Torsades de Pointes (TdP)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>George Haig, PharmD</last_name>
    <role>Study Director</role>
    <affiliation>AbbVie</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 74436</name>
      <address>
        <city>Chino</city>
        <state>California</state>
        <zip>91710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 72704</name>
      <address>
        <city>Garden Grove</city>
        <state>California</state>
        <zip>92845</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 72699</name>
      <address>
        <city>National City</city>
        <state>California</state>
        <zip>91950</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 73983</name>
      <address>
        <city>Oceanside</city>
        <state>California</state>
        <zip>92056</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 73236</name>
      <address>
        <city>Orange</city>
        <state>California</state>
        <zip>92868</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 86974</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 72701</name>
      <address>
        <city>Torrance</city>
        <state>California</state>
        <zip>90502</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 75314</name>
      <address>
        <city>Bradenton</city>
        <state>Florida</state>
        <zip>34201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 75146</name>
      <address>
        <city>Maitland</city>
        <state>Florida</state>
        <zip>32751</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 75654</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30308</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 72703</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60640</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 76534</name>
      <address>
        <city>Hoffman Estates</city>
        <state>Illinois</state>
        <zip>60169</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 73984</name>
      <address>
        <city>Lake Charles</city>
        <state>Louisiana</state>
        <zip>70629</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 73981</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 89553</name>
      <address>
        <city>Marlton</city>
        <state>New Jersey</state>
        <zip>08053</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 72700</name>
      <address>
        <city>Cedarhurst</city>
        <state>New York</state>
        <zip>11516</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 73982</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 113035</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73116</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 72702</name>
      <address>
        <city>DeSoto</city>
        <state>Texas</state>
        <zip>75115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 75147</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77008</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>Haig GM, Wang D, Zhao J, Othman AA, Bain EE. Efficacy and Safety of the alpha7-Nicotinic Acetylcholine Receptor Agonist ABT-126 in the Treatment of Cognitive Impairment Associated With Schizophrenia: Results From a Phase 2b Randomized Controlled Study in Smokers. J Clin Psychiatry. 2018 May/Jun;79(3):16m11162. doi: 10.4088/JCP.16m11162.</citation>
    <PMID>28922590</PMID>
  </results_reference>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>August 31, 2012</study_first_submitted>
  <study_first_submitted_qc>September 4, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 5, 2012</study_first_posted>
  <disposition_first_submitted>March 4, 2015</disposition_first_submitted>
  <disposition_first_submitted_qc>March 4, 2015</disposition_first_submitted_qc>
  <disposition_first_posted type="Estimate">March 24, 2015</disposition_first_posted>
  <last_update_submitted>July 2, 2021</last_update_submitted>
  <last_update_submitted_qc>July 2, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 7, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>schizophrenia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Schizophrenia</mesh_term>
    <mesh_term>Cognition Disorders</mesh_term>
    <mesh_term>Cognitive Dysfunction</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/NCT01678755
org study id: M13-608
nct id: NCT01678755
lead sponsor: 
has dmc: Yes
This is an efficacy study evaluating a experimental treatment for cognitive deficits in
      adults with schizophrenia.
Safety and Efficacy Study for Cognitive Deficits in Adult Subjects with Schizophrenia.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Cognition: MCCB (MATRICS Consensus Cognitive Battery) change from baseline to week 12
time frame: Change from baseline to week 12
description: Rater based interview
measure: Functioning: UPSA-2 (University of California San Diego Performance-based Skills Assessment-2)
time frame: Measurements from screening period up through week 12
description: Rater based interview
measure: Symptom Severity: PANSS (Positive and Negative Syndrome Scale)
time frame: Measurements from screening period up through week 12
description: Rater based interview
measure: Symptom Severity: NSA-16 (16-item version of the Negative Symptom Assessment Scale)
time frame: Measurements from screening period up through week 12
description: Rater based interview
arm group label: ABT-126 Low Dose
arm group type: Experimental
description: ABT-126 Low Dose
arm group label: ABT-126 High Dose
arm group type: Experimental
description: ABT-126 High Dose
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo
intervention type: Drug
intervention name: ABT-126
description: ABT-126 Low Dose
arm group label: ABT-126 Low Dose
intervention type: Drug
intervention name: ABT-126
description: ABT-126 High Dose
arm group label: ABT-126 High Dose
intervention type: Drug
intervention name: Placebo
description: Placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 20 Years
maximum age: 55 Years
healthy volunteers: No
last name: George Haig, PharmD
role: Study Director
affiliation: AbbVie
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country: United States
citation: Haig GM, Wang D, Zhao J, Othman AA, Bain EE. Efficacy and Safety of the alpha7-Nicotinic Acetylcholine Receptor Agonist ABT-126 in the Treatment of Cognitive Impairment Associated With Schizophrenia: Results From a Phase 2b Randomized Controlled Study in Smokers. J Clin Psychiatry. 2018 May/Jun;79(3):16m11162. doi: 10.4088/JCP.16m11162.
PMID: 28922590
responsible party type: Sponsor
mesh term: Schizophrenia
mesh term: Cognition Disorders
mesh term: Cognitive Dysfunction