0.1.1 - ci-build
ScheduleOfActivityIG - Local Development build (v0.1.1). See the Directory of published versions
<Bundle xmlns="http://hl7.org/fhir">
<id value="H2Q-MC-LZZT-Bundle-1"/>
<type value="transaction"/>
<entry>
<fullUrl value="ResearchStudy/H2Q-MC-LZZT-ResearchStudy"/>
<resource>
<ResearchStudy>
<id value="H2Q-MC-LZZT-ResearchStudy"/>
<text>
<status value="generated"/>
<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)
### 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>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>
</text>
<identifier>
<use value="usual"/>
<value value="H2Q-MC-LZZT"/>
</identifier>
<identifier>
<use value="official"/>
<system value="https://clinicaltrials.gov/show/"/>
<value value="NCTA12313212"/>
</identifier>
<identifier>
<use value="secondary"/>
<type>
<coding>
<code value="PLAC"/>
</coding>
</type>
<value value="NCTA12313212"/>
</identifier>
<identifier>
<type>
<coding>
<code value="PUBCHEM"/>
</coding>
</type>
<value value="60809"/>
</identifier>
<title
value="Safety and Efficacy of the Xanomeline Transdermal Therapeutic System (TTS) in Patients with Mild to Moderate Alzheimer’s Disease"/>
<protocol>
<reference value="PlanDefinition/H2Q-MC-LZZT-ProtocolDesign"/>
</protocol>
<status value="completed"/>
<primaryPurposeType>
<coding>
<code value="treatment"/>
</coding>
</primaryPurposeType>
<phase>
<coding>
<code value="phase-3"/>
</coding>
</phase>
<category>
<coding>
<system value="http://ncimeta.nci.nih.gov"/>
<code value="C98388"/>
<display value="Interventional Study"/>
</coding>
</category>
<category>
<coding>
<system value="http://ncimeta.nci.nih.gov"/>
<code value="C15417"/>
<display value="Randomized Clinical Trial"/>
</coding>
</category>
<category>
<coding>
<system value="http://ncimeta.nci.nih.gov"/>
<code value="C15228"/>
<display value="Double Blind Study"/>
</coding>
</category>
<category>
<coding>
<system value="http://ncimeta.nci.nih.gov"/>
<code value="C49648"/>
<display value="Placebo Control"/>
</coding>
</category>
<category>
<coding>
<system value="http://ncimeta.nci.nih.gov"/>
<code value="C82639"/>
<display value="Parallel Study"/>
</coding>
</category>
<focus>
<coding>
<system value="http://ncimeta.nci.nih.gov"/>
<code value="C152926"/>
<display value="Xanomeline"/>
</coding>
</focus>
<focus>
<coding>
<system value="http://ncimeta.nci.nih.gov"/>
<code value="C149996"/>
<display value="Transdermal Patch Dosage Form"/>
</coding>
</focus>
<focus>
<coding>
<system value="https://pubmed.ncbi.nlm.nih.gov"/>
<code value="9109749"/>
<display
value="Effects of xanomeline, a selective muscarinic receptor agonist, on cognitive function and behavioral symptoms in Alzheimer disease"/>
</coding>
</focus>
<condition>
<coding>
<code value="26929004"/>
<display value="Alzheimer's Disease (Disorder)"/>
</coding>
</condition>
<contact>
<name value="Bob James, Ph.D."/>
<telecom>
<system value="phone"/>
<value value="555-555-5555"/>
<use value="work"/>
</telecom>
</contact>
<relatedArtifact>
<type value="documentation"/>
<label value="Arch Neurol.1997;54(4):465-473"/>
<display value="Arch Neurol.1997;54(4):465-473"/>
<citation
value="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"/>
</relatedArtifact>
<relatedArtifact>
<type value="documentation"/>
<label value="Protocol H2Q-MC-LZZT(c)"/>
<url
value="https://clinicaltrials.gov/show/NCTA12313212/Lzzt_protocol_redacted.pdf"/>
</relatedArtifact>
<keyword>
<coding>
<system value="https://id.nlm.nih.gov/mesh"/>
<code value="D018721"/>
</coding>
<text value="Selective M1 muscarinic agonists"/>
</keyword>
<keyword>
<coding>
<system value="https://id.nlm.nih.gov/mesh"/>
<code value="D000544"/>
</coding>
<text value="Alzheimer Disease"/>
</keyword>
<keyword>
<coding>
<system value="https://id.nlm.nih.gov/mesh"/>
<code value="D018721"/>
</coding>
<text value="Selective M1 muscarinic agonists"/>
</keyword>
<description
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"/>
<enrollment>
<reference value="Group/H2Q-MC-LZZT-ResearchStudy-Inclusion"/>
</enrollment>
<enrollment>
<reference value="Group/H2Q-MC-LZZT-ResearchStudy-Exclusion"/>
</enrollment>
<sponsor>
<reference value="Organization/EliLillyAndCompany"/>
</sponsor>
<principalInvestigator>
<reference value="Practitioner/SamGetWell"/>
</principalInvestigator>
<reasonStopped>
<coding>
<code value="accrual-goal-met"/>
</coding>
</reasonStopped>
<arm>
<name value="Placebo"/>
<type>
<coding>
<system value="http://ncimeta.nci.nih.gov"/>
<code value="C49648"/>
</coding>
</type>
<description value="Placebo arm"/>
</arm>
<arm>
<name value="Low-dose xanomeline arm"/>
<type>
<coding>
<system value="http://ncimeta.nci.nih.gov"/>
<code value="C174266"/>
</coding>
</type>
<description
value="Low-dose xanomeline arm (50 cm2 TTS Formulation E, 54 mg xanomeline)"/>
</arm>
<arm>
<name value="High-dose xanomeline arm"/>
<type>
<coding>
<system value="http://ncimeta.nci.nih.gov"/>
<code value="C174266"/>
</coding>
</type>
<description
value="High-dose xanomeline arm (75 cm2 TTS Formulation E, 81 mg xanomeline)"/>
</arm>
<objective>
<name
value="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 value="primary"/>
</coding>
</type>
</objective>
<objective>
<name value="To document the safety profile of the xanomeline TTS."/>
<type>
<coding>
<code value="primary"/>
</coding>
</type>
</objective>
<objective>
<name
value="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 value="secondary"/>
</coding>
</type>
</objective>
<objective>
<name
value="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 value="secondary"/>
</coding>
</type>
</objective>
<objective>
<name
value="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 value="secondary"/>
</coding>
</type>
</objective>
<objective>
<name
value="To assess the treatment response as a function of Apo E genotype."/>
<type>
<coding>
<code value="secondary"/>
</coding>
</type>
</objective>
</ResearchStudy>
</resource>
<request>
<method value="POST"/>
<url value="ResearchStudy"/>
</request>
</entry>
</Bundle>