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Narrative

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Source1

{
  "resourceType": "ResearchStudy",
  "id": "H2Q-MC-LZZT-ResearchStudy",
  "meta": {
    "profile": [
      "http://hl7.org/fhir/uv/vulcan-schedule/StructureDefinition/ResearchStudySoa"
    ]
  },
  "language": "en",
  "text": {
    "status": "generated",
    "div": "<!-- snip (see above) -->"
  },
  "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"
          }
        ]
      }
    }
  ]
}