Clinical Study Schedule of Activities, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 2.0.0-ballot built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/Vulcan-schedule-ig/ and changes regularly. See the Directory of published versions

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: H2Q-MC-LZZT Research Study

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<ResearchStudy xmlns="http://hl7.org/fhir">
  <id value="H2Q-MC-LZZT-ResearchStudy"/>
  <meta>
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             value="http://hl7.org/fhir/uv/vulcan-schedule/StructureDefinition/ResearchStudySoa"/>
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  <language value="en"/>
  <text>
    <status value="generated"/>
    <div xmlns="http://www.w3.org/1999/xhtml" xml:lang="en" lang="en"><p class="res-header-id"><b>Generated Narrative: ResearchStudy H2Q-MC-LZZT-ResearchStudy</b></p><a name="H2Q-MC-LZZT-ResearchStudy"> </a><a name="hcH2Q-MC-LZZT-ResearchStudy"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">Language: en</p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-ResearchStudySoa.html">ResearchStudySoa</a></p></div><p><b>identifier</b>: H2Q-MC-LZZT (use: usual, ), <code>https://clinicaltrials.gov/show/</code>/NCTA12313212 (use: official, ), 60809</p><p><b>title</b>: Safety and Efficacy of the Xanomeline Transdermal Therapeutic System (TTS) in Patients with Mild to Moderate Alzheimer’s Disease</p><p><b>protocol</b>: <a href="PlanDefinition-H2Q-MC-LZZT-ProtocolDesign.html">H2Q-MC-LZZT Protocol Schedule of Activities</a></p><p><b>status</b>: Retired</p><p><b>primaryPurposeType</b>: <span title="Codes:{http://terminology.hl7.org/CodeSystem/research-study-prim-purp-type treatment}">Treatment</span></p><p><b>phase</b>: <span title="Codes:{http://terminology.hl7.org/CodeSystem/research-study-phase phase-3}">Phase 3</span></p><p><b>condition</b>: <span title="Codes:{http://snomed.info/sct 26929004}">Alzheimer's Disease (Disorder)</span></p><p><b>keyword</b>: <span title="Codes:{https://www.nlm.nih.gov/mesh D018721}">Selective M1 muscarinic agonists</span>, <span title="Codes:{https://www.nlm.nih.gov/mesh D000544}">Alzheimer Disease</span>, <span title="Codes:{https://www.nlm.nih.gov/mesh D018721}">Selective M1 muscarinic agonists</span></p><p><b>description</b>: </p><div><h2>Xanomeline (LY246708)</h2>
<h3>Protocol H2Q-MC-LZZT(c)</h3>
<p>Safety and Efficacy of the Xanomeline Transdermal Therapeutic System (TTS) in Patients with Mild to Moderate Alzheimer’s Disease</p>
</div><blockquote><p><b>objective</b></p><p><b>name</b>: To determine if there is a statistically significant relationship (overall Type 1 error rate, α=.05) between the change in both ADAS-Cog and CIBIC scores, and drug dose (0, 50 cm2 [54 mg], and 75 cm2 [81 mg]).</p><p><b>type</b>: <span title="Codes:{http://terminology.hl7.org/CodeSystem/research-study-objective-type primary}">Primary</span></p></blockquote><blockquote><p><b>objective</b></p><p><b>name</b>: To document the safety profile of the xanomeline TTS.</p><p><b>type</b>: <span title="Codes:{http://terminology.hl7.org/CodeSystem/research-study-objective-type primary}">Primary</span></p></blockquote><blockquote><p><b>objective</b></p><p><b>name</b>: To assess the dose-dependent improvement in behavior. Improved scores on the Revised Neuropsychiatric Inventory (NPI-X) will indicate improvement in these areas.</p><p><b>type</b>: <span title="Codes:{http://terminology.hl7.org/CodeSystem/research-study-objective-type secondary}">Secondary</span></p></blockquote><blockquote><p><b>objective</b></p><p><b>name</b>: To assess the dose-dependent improvements in activities of daily living. Improved scores on the Disability Assessment for Dementia (DAD) will indicate improvement in these areas.</p><p><b>type</b>: <span title="Codes:{http://terminology.hl7.org/CodeSystem/research-study-objective-type secondary}">Secondary</span></p></blockquote><blockquote><p><b>objective</b></p><p><b>name</b>: To assess the dose-dependent improvements in an extended assessment of cognition that integrates attention/concentration tasks. The Alzheimer’s Disease Assessment Scale-14 item Cognitive Subscale, hereafter referred to as ADAS-Cog (14), will be used for this assessment.</p><p><b>type</b>: <span title="Codes:{http://terminology.hl7.org/CodeSystem/research-study-objective-type secondary}">Secondary</span></p></blockquote><blockquote><p><b>objective</b></p><p><b>name</b>: To assess the treatment response as a function of Apo E genotype.</p><p><b>type</b>: <span title="Codes:{http://terminology.hl7.org/CodeSystem/research-study-objective-type secondary}">Secondary</span></p></blockquote></div>
  </text>
  <identifier>
    <use value="usual"/>
    <value value="H2Q-MC-LZZT"/>
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  <identifier>
    <use value="official"/>
    <system value="https://clinicaltrials.gov/show/"/>
    <value value="NCTA12313212"/>
  </identifier>
  <identifier>
    <value value="60809"/>
  </identifier>
  <title
         value="Safety and Efficacy of the Xanomeline Transdermal Therapeutic System (TTS) in Patients with Mild to Moderate Alzheimer’s Disease"/>
  <protocol>🔗 
    <reference value="PlanDefinition/H2Q-MC-LZZT-ProtocolDesign"/>
  </protocol>
  <status value="retired"/>
  <primaryPurposeType>
    <coding>
      <system
              value="http://terminology.hl7.org/CodeSystem/research-study-prim-purp-type"/>
      <code value="treatment"/>
    </coding>
  </primaryPurposeType>
  <phase>
    <coding>
      <system
              value="http://terminology.hl7.org/CodeSystem/research-study-phase"/>
      <code value="phase-3"/>
    </coding>
  </phase>
  <condition>
    <coding>
      <system value="http://snomed.info/sct"/>
      <code value="26929004"/>
      <display value="Alzheimer's Disease (Disorder)"/>
    </coding>
  </condition>
  <keyword>
    <coding>
      <system value="https://www.nlm.nih.gov/mesh"/>
      <code value="D018721"/>
    </coding>
    <text value="Selective M1 muscarinic agonists"/>
  </keyword>
  <keyword>
    <coding>
      <system value="https://www.nlm.nih.gov/mesh"/>
      <code value="D000544"/>
    </coding>
    <text value="Alzheimer Disease"/>
  </keyword>
  <keyword>
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      <system value="https://www.nlm.nih.gov/mesh"/>
      <code value="D018721"/>
    </coding>
    <text value="Selective M1 muscarinic agonists"/>
  </keyword>
  <description
               value="## Xanomeline (LY246708)
### Protocol H2Q-MC-LZZT(c) 
Safety and Efficacy of the Xanomeline Transdermal Therapeutic System (TTS) in Patients with Mild to Moderate Alzheimer’s Disease"/>
  <objective>
    <name
          value="To determine if there is a statistically significant relationship (overall Type 1 error rate, α=.05) between the change in both ADAS-Cog and CIBIC scores, and drug dose (0, 50 cm2 [54 mg], and 75 cm2 [81 mg])."/>
    <type>
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        <system
                value="http://terminology.hl7.org/CodeSystem/research-study-objective-type"/>
        <code value="primary"/>
      </coding>
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  <objective>
    <name value="To document the safety profile of the xanomeline TTS."/>
    <type>
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                value="http://terminology.hl7.org/CodeSystem/research-study-objective-type"/>
        <code value="primary"/>
      </coding>
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  </objective>
  <objective>
    <name
          value="To assess the dose-dependent improvement in behavior. Improved scores on the Revised Neuropsychiatric Inventory (NPI-X) will indicate improvement in these areas."/>
    <type>
      <coding>
        <system
                value="http://terminology.hl7.org/CodeSystem/research-study-objective-type"/>
        <code value="secondary"/>
      </coding>
    </type>
  </objective>
  <objective>
    <name
          value="To assess the dose-dependent improvements in activities of daily living. Improved scores on the Disability Assessment for Dementia (DAD) will indicate improvement in these areas."/>
    <type>
      <coding>
        <system
                value="http://terminology.hl7.org/CodeSystem/research-study-objective-type"/>
        <code value="secondary"/>
      </coding>
    </type>
  </objective>
  <objective>
    <name
          value="To assess the dose-dependent improvements in an extended assessment of cognition that integrates attention/concentration tasks. The Alzheimer’s Disease Assessment Scale-14 item Cognitive Subscale, hereafter referred to as ADAS-Cog (14), will be used for this assessment."/>
    <type>
      <coding>
        <system
                value="http://terminology.hl7.org/CodeSystem/research-study-objective-type"/>
        <code value="secondary"/>
      </coding>
    </type>
  </objective>
  <objective>
    <name
          value="To assess the treatment response as a function of Apo E genotype."/>
    <type>
      <coding>
        <system
                value="http://terminology.hl7.org/CodeSystem/research-study-objective-type"/>
        <code value="secondary"/>
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</ResearchStudy>