0.1.1 - ci-build
ScheduleOfActivityIG - Local Development build (v0.1.1). See the Directory of published versions
{
"resourceType" : "Bundle",
"id" : "H2Q-MC-LZZT-Bundle-1",
"type" : "transaction",
"entry" : [
{
"fullUrl" : "ResearchStudy/H2Q-MC-LZZT-ResearchStudy",
"resource" : {
"resourceType" : "ResearchStudy",
"id" : "H2Q-MC-LZZT-ResearchStudy",
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative</b></p><p><b>identifier</b>: id: H2Q-MC-LZZT (USUAL), id: NCTA12313212 (OFFICIAL), PLAC: NCTA12313212 (SECONDARY), PUBCHEM: 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\">Generated Summary: url: http://example.org/br-and-r/soa/PlanDefinition/H2Q-MC-LZZT-ProtocolDesign; version: 0.1.1; status: active; date: May 26, 2021, 2:52:13 PM</a></p><p><b>status</b>: completed</p><p><b>primaryPurposeType</b>: <span title=\"Codes: \">treatment</span></p><p><b>phase</b>: <span title=\"Codes: \">phase-3</span></p><p><b>category</b>: <span title=\"Codes: {http://ncimeta.nci.nih.gov C98388}\">Interventional Study</span>, <span title=\"Codes: {http://ncimeta.nci.nih.gov C15417}\">Randomized Clinical Trial</span>, <span title=\"Codes: {http://ncimeta.nci.nih.gov C15228}\">Double Blind Study</span>, <span title=\"Codes: {http://ncimeta.nci.nih.gov C49648}\">Placebo Control</span>, <span title=\"Codes: {http://ncimeta.nci.nih.gov C82639}\">Parallel Study</span></p><p><b>focus</b>: <span title=\"Codes: {http://ncimeta.nci.nih.gov C152926}\">Xanomeline</span>, <span title=\"Codes: {http://ncimeta.nci.nih.gov C149996}\">Transdermal Patch Dosage Form</span>, <span title=\"Codes: {https://pubmed.ncbi.nlm.nih.gov 9109749}\">Effects of xanomeline, a selective muscarinic receptor agonist, on cognitive function and behavioral symptoms in Alzheimer disease</span></p><p><b>condition</b>: <span title=\"Codes: \">Alzheimer's Disease (Disorder)</span></p><p><b>contact</b>: Bob James, Ph.D.: ph: 555-555-5555(WORK)</p><h3>RelatedArtifacts</h3><table class=\"grid\"><tr><td>-</td></tr><tr><td>*</td></tr><tr><td>*</td></tr></table><p><b>keyword</b>: <span title=\"Codes: {https://id.nlm.nih.gov/mesh D018721}\">Selective M1 muscarinic agonists</span>, <span title=\"Codes: {https://id.nlm.nih.gov/mesh D000544}\">Alzheimer Disease</span>, <span title=\"Codes: {https://id.nlm.nih.gov/mesh D018721}\">Selective M1 muscarinic agonists</span></p><p><b>description</b>: ## 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</p><p><b>enrollment</b>: </p><ul><li><a href=\"Group-H2Q-MC-LZZT-ResearchStudy-Inclusion.html\">Generated Summary: type: person; </a></li><li><a href=\"Group-H2Q-MC-LZZT-ResearchStudy-Exclusion.html\">Generated Summary: type: person; </a></li></ul><p><b>sponsor</b>: <a href=\"Organization-EliLillyAndCompany.html\">Generated Summary: id: Eli Lilly and Company (OFFICIAL); <span title=\"Codes: \">crs</span></a></p><p><b>principalInvestigator</b>: <a href=\"Practitioner-SamGetWell.html\">Generated Summary: UPIN: ABC123 (OFFICIAL); active; Samuel Home ; Phone: 555-123-5467; gender: male</a></p><p><b>reasonStopped</b>: <span title=\"Codes: \">accrual-goal-met</span></p><blockquote><p><b>arm</b></p><p><b>name</b>: Placebo</p><p><b>type</b>: <span title=\"Codes: {http://ncimeta.nci.nih.gov C49648}\">C49648</span></p><p><b>description</b>: Placebo arm</p></blockquote><blockquote><p><b>arm</b></p><p><b>name</b>: Low-dose xanomeline arm</p><p><b>type</b>: <span title=\"Codes: {http://ncimeta.nci.nih.gov C174266}\">C174266</span></p><p><b>description</b>: Low-dose xanomeline arm (50 cm2 TTS Formulation E, 54 mg xanomeline)</p></blockquote><blockquote><p><b>arm</b></p><p><b>name</b>: High-dose xanomeline arm</p><p><b>type</b>: <span title=\"Codes: {http://ncimeta.nci.nih.gov C174266}\">C174266</span></p><p><b>description</b>: High-dose xanomeline arm (75 cm2 TTS Formulation E, 81 mg xanomeline)</p></blockquote><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: \">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: \">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: \">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: \">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: \">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: \">secondary</span></p></blockquote></div>"
},
"identifier" : [
{
"use" : "usual",
"value" : "H2Q-MC-LZZT"
},
{
"use" : "official",
"system" : "https://clinicaltrials.gov/show/",
"value" : "NCTA12313212"
},
{
"use" : "secondary",
"type" : {
"coding" : [
{
"code" : "PLAC"
}
]
},
"value" : "NCTA12313212"
},
{
"type" : {
"coding" : [
{
"code" : "PUBCHEM"
}
]
},
"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" : [
{
"code" : "treatment"
}
]
},
"phase" : {
"coding" : [
{
"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"
}
]
},
{
"coding" : [
{
"system" : "https://pubmed.ncbi.nlm.nih.gov",
"code" : "9109749",
"display" : "Effects of xanomeline, a selective muscarinic receptor agonist, on cognitive function and behavioral symptoms in Alzheimer disease"
}
]
}
],
"condition" : [
{
"coding" : [
{
"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://id.nlm.nih.gov/mesh",
"code" : "D018721"
}
],
"text" : "Selective M1 muscarinic agonists"
},
{
"coding" : [
{
"system" : "https://id.nlm.nih.gov/mesh",
"code" : "D000544"
}
],
"text" : "Alzheimer Disease"
},
{
"coding" : [
{
"system" : "https://id.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",
"enrollment" : [
{
"reference" : "Group/H2Q-MC-LZZT-ResearchStudy-Inclusion"
},
{
"reference" : "Group/H2Q-MC-LZZT-ResearchStudy-Exclusion"
}
],
"sponsor" : {
"reference" : "Organization/EliLillyAndCompany"
},
"principalInvestigator" : {
"reference" : "Practitioner/SamGetWell"
},
"reasonStopped" : {
"coding" : [
{
"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" : [
{
"code" : "primary"
}
]
}
},
{
"name" : "To document the safety profile of the xanomeline TTS.",
"type" : {
"coding" : [
{
"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" : [
{
"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" : [
{
"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" : [
{
"code" : "secondary"
}
]
}
},
{
"name" : "To assess the treatment response as a function of Apo E genotype.",
"type" : {
"coding" : [
{
"code" : "secondary"
}
]
}
}
]
},
"request" : {
"method" : "POST",
"url" : "ResearchStudy"
}
}
]
}