Clinical Study Schedule of Activites
1.0.0-ballot - ballot
Clinical Study Schedule of Activites
1.0.0-ballot - ballot
This page is part of the Clinical Study Schedule of Activities (v1.0.0-ballot: STU1 Ballot 1) based on FHIR R4. . For a full list of available versions, see the Directory of published versions 
{
"resourceType" : "ResearchStudy",
"id" : "H2Q-MC-LZZT-ResearchStudy",
"meta" : {
"profile" : [
"http://hl7.org/fhir/uv/vulcan-schedule/StructureDefinition/ResearchStudySoa"
]
},
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: ResearchStudy</b><a name=\"H2Q-MC-LZZT-ResearchStudy\"> </a></p><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\">Resource ResearchStudy "H2Q-MC-LZZT-ResearchStudy" </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-ResearchStudySoa.html\">ResearchStudySoa</a></p></div><p><b>identifier</b>: id: H2Q-MC-LZZT (use: USUAL), id: NCTA12313212 (use: OFFICIAL), id: 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\">PlanDefinition/H2Q-MC-LZZT-ProtocolDesign</a></p><p><b>status</b>: completed</p><p><b>primaryPurposeType</b>: Treatment <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.0.0/CodeSystem-research-study-prim-purp-type.html\">ResearchStudyPrimaryPurposeType</a>#treatment)</span></p><p><b>phase</b>: Phase 3 <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.0.0/CodeSystem-research-study-phase.html\">ResearchStudyPhase</a>#phase-3)</span></p><p><b>category</b>: Interventional Study <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (ncimeta.nci.nih.gov#C98388)</span>, Randomized Clinical Trial <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (ncimeta.nci.nih.gov#C15417)</span>, Double Blind Study <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (ncimeta.nci.nih.gov#C15228)</span>, Placebo Control <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (ncimeta.nci.nih.gov#C49648)</span>, Parallel Study <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (ncimeta.nci.nih.gov#C82639)</span></p><p><b>focus</b>: Xanomeline <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (ncimeta.nci.nih.gov#C152926)</span>, Transdermal Patch Dosage Form <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (ncimeta.nci.nih.gov#C149996)</span>, PUBMED#9109749 Effects of xanomeline, a selective muscarinic receptor agonist, on cognitive function and behavioral symptoms in Alzheimer disease <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>condition</b>: Alzheimer's Disease (Disorder) <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"https://browser.ihtsdotools.org/\">SNOMED CT</a>#26929004)</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><td><b>Type</b></td><td><b>Label</b></td><td><b>Display</b></td><td><b>Citation</b></td><td><b>Url</b></td></tr><tr><td>*</td><td>documentation</td><td>Arch Neurol.1997;54(4):465-473</td><td>Arch Neurol.1997;54(4):465-473</td><td>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</td><td> </td></tr><tr><td>*</td><td>documentation</td><td>Protocol H2Q-MC-LZZT(c)</td><td> </td><td> </td><td><a href=\"https://clinicaltrials.gov/show/NCTA12313212/Lzzt_protocol_redacted.pdf\">https://clinicaltrials.gov/show/NCTA12313212/Lzzt_protocol_redacted.pdf</a></td></tr></table><p><b>keyword</b>: Selective M1 muscarinic agonists <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.0.0/CodeSystem-MeSH.html\">Medical Subject Headings</a>#D018721)</span>, Alzheimer Disease <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.0.0/CodeSystem-MeSH.html\">Medical Subject Headings</a>#D000544)</span>, Selective M1 muscarinic agonists <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.0.0/CodeSystem-MeSH.html\">Medical Subject Headings</a>#D018721)</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>sponsor</b>: <a href=\"Organization-EliLillyAndCompany.html\">Organization/EliLillyAndCompany</a></p><p><b>principalInvestigator</b>: <a href=\"Practitioner-SamGetWell.html\">Practitioner/SamGetWell</a> " HOME"</p><p><b>reasonStopped</b>: Accrual Goal Met <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.0.0/CodeSystem-research-study-reason-stopped.html\">ResearchStudyReasonStopped</a>#accrual-goal-met)</span></p><blockquote><p><b>arm</b></p><p><b>name</b>: Placebo</p><p><b>type</b>: C49648 <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (ncimeta.nci.nih.gov#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>: C174266 <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (ncimeta.nci.nih.gov#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>: C174266 <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (ncimeta.nci.nih.gov#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>: Primary <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.0.0/CodeSystem-research-study-objective-type.html\">ResearchStudyObjectiveType</a>#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>: Primary <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.0.0/CodeSystem-research-study-objective-type.html\">ResearchStudyObjectiveType</a>#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>: Secondary <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.0.0/CodeSystem-research-study-objective-type.html\">ResearchStudyObjectiveType</a>#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>: Secondary <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.0.0/CodeSystem-research-study-objective-type.html\">ResearchStudyObjectiveType</a>#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>: Secondary <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.0.0/CodeSystem-research-study-objective-type.html\">ResearchStudyObjectiveType</a>#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>: Secondary <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.0.0/CodeSystem-research-study-objective-type.html\">ResearchStudyObjectiveType</a>#secondary)</span></p></blockquote></div>"
},
"identifier" : [
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"value" : "H2Q-MC-LZZT"
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"system" : "https://clinicaltrials.gov/show/",
"value" : "NCTA12313212"
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{
"value" : "60809"
}
],
"title" : "Safety and Efficacy of the Xanomeline Transdermal Therapeutic System (TTS) in Patients with Mild to Moderate Alzheimer’s Disease",
"protocol" : [
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"reference" : "PlanDefinition/H2Q-MC-LZZT-ProtocolDesign"
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],
"status" : "completed",
"primaryPurposeType" : {
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"category" : [
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"display" : "Interventional Study"
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"system" : "http://ncimeta.nci.nih.gov",
"code" : "C15417",
"display" : "Randomized Clinical Trial"
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"system" : "http://ncimeta.nci.nih.gov",
"code" : "C15228",
"display" : "Double Blind Study"
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{
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"system" : "http://ncimeta.nci.nih.gov",
"code" : "C49648",
"display" : "Placebo Control"
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{
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"code" : "C82639",
"display" : "Parallel Study"
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],
"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" : [
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"system" : "http://snomed.info/sct",
"code" : "26929004",
"display" : "Alzheimer's Disease (Disorder)"
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],
"contact" : [
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"name" : "Bob James, Ph.D.",
"telecom" : [
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"system" : "phone",
"value" : "555-555-5555",
"use" : "work"
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],
"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"
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],
"keyword" : [
{
"coding" : [
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"text" : "Selective M1 muscarinic agonists"
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{
"coding" : [
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"system" : "https://www.nlm.nih.gov/mesh",
"code" : "D000544"
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"text" : "Alzheimer Disease"
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{
"coding" : [
{
"system" : "https://www.nlm.nih.gov/mesh",
"code" : "D018721"
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],
"text" : "Selective M1 muscarinic agonists"
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],
"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"
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},
"arm" : [
{
"name" : "Placebo",
"type" : {
"coding" : [
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"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" : [
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"code" : "primary"
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]
}
},
{
"name" : "To document the safety profile of the xanomeline TTS.",
"type" : {
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/research-study-objective-type",
"code" : "primary"
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]
}
},
{
"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",
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},
{
"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" : [
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]
}
},
{
"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"
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]
}
}
]
}
IG © 2022+ HL7 International - Biomedical Research & Regulation Work Group. Package hl7.fhir.uv.vulcan-schedule#1.0.0-ballot based on FHIR 4.0.1. Generated 2022-12-04
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