<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/NCT02220738</url>
  </required_header>
  <id_info>
    <org_study_id>M13-334</org_study_id>
    <nct_id>NCT02220738</nct_id>
  </id_info>
  <brief_title>Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ABT-957 in Subjects With Mild-to-Moderate Alzheimer's Disease on Stable Doses of Acetylcholinesterase Inhibitors</brief_title>
  <official_title>A Multiple-Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ABT-957 in Subjects With Mild-to-Moderate Alzheimer's Disease on Stable Doses of Acetylcholinesterase Inhibitors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AbbVie</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>AbbVie</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is designed to evaluate the safety, tolerability and pharmacokinetics of multiple&#xD;
      doses of ABT-957 in subjects with mild to moderate Alzheimer's disease.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Slow subject enrollment&#xD;
  </why_stopped>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">March 2016</completion_date>
  <primary_completion_date type="Actual">March 2016</primary_completion_date>
  <phase>Phase 1</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pharmacokinetic evaluation of the two ABT-957 diastereomers</measure>
    <time_frame>Day 7</time_frame>
    <description>maximum observed plasma concentration (Cmax), time to Cmax (peak time, Tmax), plasma concentration at the end of the dosing interval (Ctrough), the area under the plasma concentration-time curve (AUC) during each dosing interval (AUC0-12 and AUC12-24)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of subjects with adverse events</measure>
    <time_frame>Routinely for the duration of the study, about 7 months</time_frame>
    <description>Subjects will be monitored for clinical and laboratory evidence of adverse events throughout the study</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">19</enrollment>
  <condition>Alzheimer's Disease</condition>
  <arm_group>
    <arm_group_label>ABT-957</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ABT-957 administered twice-daily for 7 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo administered twice-daily for 7 days</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ABT-957</intervention_name>
    <description>ABT-957 administered twice-daily for 7 days</description>
    <arm_group_label>ABT-957</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo for ABT-957</intervention_name>
    <description>Placebo for ABT-957 administered twice-daily for 7 days</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Meets the National Institute of Neurological and Communicative Disorders and&#xD;
             Stroke/Alzheimer's Disease and Related Disorders Association criteria for probable&#xD;
             Alzheimer's disease (AD);&#xD;
&#xD;
          -  Has a Mini-Mental State Examination total score of 16 to 26;&#xD;
&#xD;
          -  Has a Modified Hachinski Ischemia Scale score of ≤ 4;&#xD;
&#xD;
          -  Is taking a stable dose of donepezil, galantamine or rivastigmine for at least 30&#xD;
             days;&#xD;
&#xD;
          -  Has had a computerized tomography or magnetic resonance imaging. The scan must not&#xD;
             show evidence for an alternative etiology for dementia;&#xD;
&#xD;
          -  With the exception of a diagnosis of mild-to-moderate AD and the presence of stable&#xD;
             medical conditions, is in general good health.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Positive screen for drugs of abuse, alcohol or cotinine;&#xD;
&#xD;
          -  Females must not have positive results for pregnancy;&#xD;
&#xD;
          -  Focal neurological signs on examination;&#xD;
&#xD;
          -  Has a clinically significant abnormal value, in serum chemistry, hematology or&#xD;
             urinalysis;&#xD;
&#xD;
          -  History of any significant neurologic disease other than AD;&#xD;
&#xD;
          -  History of head trauma, motor vehicle accident, concussion.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>55 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nuno Mendonca, MD</last_name>
    <role>Study Director</role>
    <affiliation>AbbVie</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 129545</name>
      <address>
        <city>Glendale</city>
        <state>California</state>
        <zip>91206</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 129435</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32806</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 129641</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10019</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 144825</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>Lon HK, Mendonca N, Goss S, Othman AA, Locke C, Jin Z, Rendenbach-Mueller B. Pharmacokinetics, Safety, Tolerability, and Pharmacodynamics of Alicapistat, a Selective Inhibitor of Human Calpains 1 and 2 for the Treatment of Alzheimer Disease: An Overview of Phase 1 Studies. Clin Pharmacol Drug Dev. 2019 Apr;8(3):290-303. doi: 10.1002/cpdd.598. Epub 2018 Jul 27.</citation>
    <PMID>30052328</PMID>
  </results_reference>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>August 18, 2014</study_first_submitted>
  <study_first_submitted_qc>August 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 20, 2014</study_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 6, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Alzheimer's Disease</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alzheimer Disease</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT02220738
org study id: M13-334
nct id: NCT02220738
lead sponsor: 
has dmc: No
This study is designed to evaluate the safety, tolerability and pharmacokinetics of multiple
      doses of ABT-957 in subjects with mild to moderate Alzheimer's disease.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Pharmacokinetic evaluation of the two ABT-957 diastereomers
time frame: Day 7
description: maximum observed plasma concentration (Cmax), time to Cmax (peak time, Tmax), plasma concentration at the end of the dosing interval (Ctrough), the area under the plasma concentration-time curve (AUC) during each dosing interval (AUC0-12 and AUC12-24)
measure: Number of subjects with adverse events
time frame: Routinely for the duration of the study, about 7 months
description: Subjects will be monitored for clinical and laboratory evidence of adverse events throughout the study
arm group label: ABT-957
arm group type: Experimental
description: ABT-957 administered twice-daily for 7 days
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo administered twice-daily for 7 days
intervention type: Drug
intervention name: ABT-957
description: ABT-957 administered twice-daily for 7 days
arm group label: ABT-957
intervention type: Other
intervention name: Placebo for ABT-957
description: Placebo for ABT-957 administered twice-daily for 7 days
arm group label: Placebo
criteria: 
gender: All
minimum age: 55 Years
maximum age: 90 Years
healthy volunteers: No
last name: Nuno Mendonca, MD
role: Study Director
affiliation: AbbVie
facility: 
facility: 
facility: 
facility: 
country: United States
citation: Lon HK, Mendonca N, Goss S, Othman AA, Locke C, Jin Z, Rendenbach-Mueller B. Pharmacokinetics, Safety, Tolerability, and Pharmacodynamics of Alicapistat, a Selective Inhibitor of Human Calpains 1 and 2 for the Treatment of Alzheimer Disease: An Overview of Phase 1 Studies. Clin Pharmacol Drug Dev. 2019 Apr;8(3):290-303. doi: 10.1002/cpdd.598. Epub 2018 Jul 27.
PMID: 30052328
responsible party type: Sponsor
mesh term: Alzheimer Disease