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Source1

{
  "resourceType": "ResearchStudy",
  "id": "H2Q-MC-LZZT-ResearchStudy",
  "meta": {
    "profile": [
      "http://hl7.org/fhir/uv/vulcan-schedule/StructureDefinition/ResearchStudySoa"
    ]
  },
  "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": "completed",
  "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"
      }
    ]
  },
  "category": [
    {
      "coding": [
        {
          "system": "http://ncimeta.nci.nih.gov",
          "code": "C98388",
          "display": "Interventional Study"
        }
      ]
    },
    {
      "coding": [
        {
          "system": "http://ncimeta.nci.nih.gov",
          "code": "C15417",
          "display": "Randomized Clinical Trial"
        }
      ]
    },
    {
      "coding": [
        {
          "system": "http://ncimeta.nci.nih.gov",
          "code": "C15228",
          "display": "Double Blind Study"
        }
      ]
    },
    {
      "coding": [
        {
          "system": "http://ncimeta.nci.nih.gov",
          "code": "C49648",
          "display": "Placebo Control"
        }
      ]
    },
    {
      "coding": [
        {
          "system": "http://ncimeta.nci.nih.gov",
          "code": "C82639",
          "display": "Parallel Study"
        }
      ]
    }
  ],
  "focus": [
    {
      "coding": [
        {
          "system": "http://ncimeta.nci.nih.gov",
          "code": "C152926",
          "display": "Xanomeline"
        }
      ]
    },
    {
      "coding": [
        {
          "system": "http://ncimeta.nci.nih.gov",
          "code": "C149996",
          "display": "Transdermal Patch Dosage Form"
        }
      ]
    },
    {
      "text": "PUBMED#9109749 Effects of xanomeline, a selective muscarinic receptor agonist, on cognitive function and behavioral symptoms in Alzheimer disease"
    }
  ],
  "condition": [
    {
      "coding": [
        {
          "system": "http://snomed.info/sct",
          "code": "26929004",
          "display": "Alzheimer's Disease (Disorder)"
        }
      ]
    }
  ],
  "contact": [
    {
      "name": "Bob James, Ph.D.",
      "telecom": [
        {
          "system": "phone",
          "value": "555-555-5555",
          "use": "work"
        }
      ]
    }
  ],
  "relatedArtifact": [
    {
      "type": "documentation",
      "label": "Arch Neurol.1997;54(4):465-473",
      "display": "Arch Neurol.1997;54(4):465-473",
      "citation": "Bodick NC, Offen WW, Levey AI, et al. Effects of xanomeline, a selective muscarinic receptor agonist, on cognitive function and behavioral symptoms in Alzheimer disease. Arch Neurol. 1997;54(4):465-473. doi:10.1001/archneur.1997.00550160091022"
    },
    {
      "type": "documentation",
      "label": "Protocol H2Q-MC-LZZT(c)",
      "url": "https://clinicaltrials.gov/show/NCTA12313212/Lzzt_protocol_redacted.pdf"
    }
  ],
  "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",
  "sponsor": {
    "reference": "Organization/EliLillyAndCompany"
  },
  "principalInvestigator": {
    "reference": "Practitioner/SamGetWell"
  },
  "reasonStopped": {
    "coding": [
      {
        "system": "http://terminology.hl7.org/CodeSystem/research-study-reason-stopped",
        "code": "accrual-goal-met"
      }
    ]
  },
  "arm": [
    {
      "name": "Placebo",
      "type": {
        "coding": [
          {
            "system": "http://ncimeta.nci.nih.gov",
            "code": "C49648"
          }
        ]
      },
      "description": "Placebo arm"
    },
    {
      "name": "Low-dose xanomeline arm",
      "type": {
        "coding": [
          {
            "system": "http://ncimeta.nci.nih.gov",
            "code": "C174266"
          }
        ]
      },
      "description": "Low-dose xanomeline arm (50 cm2 TTS Formulation E, 54 mg xanomeline)"
    },
    {
      "name": "High-dose xanomeline arm",
      "type": {
        "coding": [
          {
            "system": "http://ncimeta.nci.nih.gov",
            "code": "C174266"
          }
        ]
      },
      "description": "High-dose xanomeline arm (75 cm2 TTS Formulation E, 81 mg xanomeline)"
    }
  ],
  "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"
          }
        ]
      }
    }
  ]
}