0.1.1 - ci-build
ScheduleOfActivityIG - Local Development build (v0.1.1). See the Directory of published versions
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<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>
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<label value="Arch Neurol.1997;54(4):465-473"/>
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<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"/>
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### 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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