Clinical Study Schedule of Activities
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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

: H2Q-MC-LZZT Research Study

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{
  "resourceType" : "ResearchStudy",
  "id" : "H2Q-MC-LZZT-ResearchStudy",
  "meta" : {
    "profile" : [
      🔗 "http://hl7.org/fhir/uv/vulcan-schedule/StructureDefinition/ResearchStudySoa"
    ]
  },
  "language" : "en",
  "text" : {
    "status" : "generated",
    "div" : "<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\u00a0(use:\u00a0usual,\u00a0), <code>https://clinicaltrials.gov/show/</code>/NCTA12313212\u00a0(use:\u00a0official,\u00a0), 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>\n<h3>Protocol H2Q-MC-LZZT(c)</h3>\n<p>Safety and Efficacy of the Xanomeline Transdermal Therapeutic System (TTS) in Patients with Mild to Moderate Alzheimer’s Disease</p>\n</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>"
  },
  "identifier" : [
    {
      "use" : "usual",
      "value" : "H2Q-MC-LZZT"
    },
    {
      "use" : "official",
      "system" : "https://clinicaltrials.gov/show/",
      "value" : "NCTA12313212"
    },
    {
      "value" : "60809"
    }
  ],
  "title" : "Safety and Efficacy of the Xanomeline Transdermal Therapeutic System (TTS) in Patients with Mild to Moderate Alzheimer’s Disease",
  "protocol" : [
    {
      🔗 "reference" : "PlanDefinition/H2Q-MC-LZZT-ProtocolDesign"
    }
  ],
  "status" : "retired",
  "primaryPurposeType" : {
    "coding" : [
      {
        "system" : "http://terminology.hl7.org/CodeSystem/research-study-prim-purp-type",
        "code" : "treatment"
      }
    ]
  },
  "phase" : {
    "coding" : [
      {
        "system" : "http://terminology.hl7.org/CodeSystem/research-study-phase",
        "code" : "phase-3"
      }
    ]
  },
  "condition" : [
    {
      "coding" : [
        {
          "system" : "http://snomed.info/sct",
          "code" : "26929004",
          "display" : "Alzheimer's Disease (Disorder)"
        }
      ]
    }
  ],
  "keyword" : [
    {
      "coding" : [
        {
          "system" : "https://www.nlm.nih.gov/mesh",
          "code" : "D018721"
        }
      ],
      "text" : "Selective M1 muscarinic agonists"
    },
    {
      "coding" : [
        {
          "system" : "https://www.nlm.nih.gov/mesh",
          "code" : "D000544"
        }
      ],
      "text" : "Alzheimer Disease"
    },
    {
      "coding" : [
        {
          "system" : "https://www.nlm.nih.gov/mesh",
          "code" : "D018721"
        }
      ],
      "text" : "Selective M1 muscarinic agonists"
    }
  ],
  "description" : "## Xanomeline (LY246708)\n### Protocol H2Q-MC-LZZT(c) \nSafety and Efficacy of the Xanomeline Transdermal Therapeutic System (TTS) in Patients with Mild to Moderate Alzheimer’s Disease",
  "objective" : [
    {
      "name" : "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" : {
        "coding" : [
          {
            "system" : "http://terminology.hl7.org/CodeSystem/research-study-objective-type",
            "code" : "primary"
          }
        ]
      }
    },
    {
      "name" : "To document the safety profile of the xanomeline TTS.",
      "type" : {
        "coding" : [
          {
            "system" : "http://terminology.hl7.org/CodeSystem/research-study-objective-type",
            "code" : "primary"
          }
        ]
      }
    },
    {
      "name" : "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" : "http://terminology.hl7.org/CodeSystem/research-study-objective-type",
            "code" : "secondary"
          }
        ]
      }
    },
    {
      "name" : "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" : "http://terminology.hl7.org/CodeSystem/research-study-objective-type",
            "code" : "secondary"
          }
        ]
      }
    },
    {
      "name" : "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" : "http://terminology.hl7.org/CodeSystem/research-study-objective-type",
            "code" : "secondary"
          }
        ]
      }
    },
    {
      "name" : "To assess the treatment response as a function of Apo E genotype.",
      "type" : {
        "coding" : [
          {
            "system" : "http://terminology.hl7.org/CodeSystem/research-study-objective-type",
            "code" : "secondary"
          }
        ]
      }
    }
  ]
}