Clinical Study Schedule of Activities
1.0.0 - trial-use
Clinical Study Schedule of Activities
1.0.0 - trial-use
Clinical Study Schedule of Activities, published by HL7 International - Biomedical Research & Regulation Work Group. This is not an authorized publication; it is the continuous build for version 1.0.0). 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
<ResearchStudy xmlns="http://hl7.org/fhir">
<id value="H2Q-MC-LZZT-ResearchStudy"/>
<meta>
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<text>
<status value="generated"/>
<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)
### Protocol H2Q-MC-LZZT(c)
Safety 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>
</text>
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<system value="https://clinicaltrials.gov/show/"/>
<value value="NCTA12313212"/>
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value="PUBMED#9109749 Effects of xanomeline, a selective muscarinic receptor agonist, on cognitive function and behavioral symptoms in Alzheimer disease"/>
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value="## Xanomeline (LY246708)
### Protocol H2Q-MC-LZZT(c)
Safety and Efficacy of the Xanomeline Transdermal Therapeutic System (TTS) in Patients with Mild to Moderate Alzheimer’s Disease"/>
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<name value="Placebo"/>
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<coding>
<system value="http://ncimeta.nci.nih.gov"/>
<code value="C49648"/>
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<description value="Placebo arm"/>
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<arm>
<name value="Low-dose xanomeline arm"/>
<type>
<coding>
<system value="http://ncimeta.nci.nih.gov"/>
<code value="C174266"/>
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value="Low-dose xanomeline arm (50 cm2 TTS Formulation E, 54 mg xanomeline)"/>
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<objective>
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<objective>
<name value="To document the safety profile of the xanomeline TTS."/>
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<objective>
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<objective>
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<type>
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<objective>
<name
value="To assess the treatment response as a function of Apo E genotype."/>
<type>
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IG © 2022+ HL7 International - Biomedical Research & Regulation Work Group. Package hl7.fhir.uv.vulcan-schedule#1.0.0 based on FHIR 4.0.1. Generated 2023-04-18
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