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
Generated Narrative: ResearchStudy
Resource ResearchStudy "H2Q-MC-LZZT-ResearchStudy"
Profile: ResearchStudySoa
identifier: id: H2Q-MC-LZZT (use: USUAL), id: NCTA12313212 (use: OFFICIAL), id: 60809
title: Safety and Efficacy of the Xanomeline Transdermal Therapeutic System (TTS) in Patients with Mild to Moderate Alzheimer’s Disease
protocol: PlanDefinition/H2Q-MC-LZZT-ProtocolDesign
status: completed
primaryPurposeType: Treatment (ResearchStudyPrimaryPurposeType#treatment)
phase: Phase 3 (ResearchStudyPhase#phase-3)
category: Interventional Study (ncimeta.nci.nih.gov#C98388), Randomized Clinical Trial (ncimeta.nci.nih.gov#C15417), Double Blind Study (ncimeta.nci.nih.gov#C15228), Placebo Control (ncimeta.nci.nih.gov#C49648), Parallel Study (ncimeta.nci.nih.gov#C82639)
focus: Xanomeline (ncimeta.nci.nih.gov#C152926), Transdermal Patch Dosage Form (ncimeta.nci.nih.gov#C149996), PUBMED#9109749 Effects of xanomeline, a selective muscarinic receptor agonist, on cognitive function and behavioral symptoms in Alzheimer disease ()
condition: Alzheimer's Disease (Disorder) (SNOMED CT#26929004)
contact: Bob James, Ph.D.: ph: 555-555-5555(WORK)
| - | Type | Label | Display | Citation | Url |
| * | documentation | Arch Neurol.1997;54(4):465-473 | Arch Neurol.1997;54(4):465-473 | 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 | |
| * | documentation | Protocol H2Q-MC-LZZT(c) | https://clinicaltrials.gov/show/NCTA12313212/Lzzt_protocol_redacted.pdf |
keyword: Selective M1 muscarinic agonists (Medical Subject Headings#D018721), Alzheimer Disease (Medical Subject Headings#D000544), Selective M1 muscarinic agonists (Medical Subject Headings#D018721)
description: ## 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
sponsor: Organization/EliLillyAndCompany
principalInvestigator: Practitioner/SamGetWell " HOME"
reasonStopped: Accrual Goal Met (ResearchStudyReasonStopped#accrual-goal-met)
arm
name: Placebo
type: C49648 (ncimeta.nci.nih.gov#C49648)
description: Placebo arm
arm
name: Low-dose xanomeline arm
type: C174266 (ncimeta.nci.nih.gov#C174266)
description: Low-dose xanomeline arm (50 cm2 TTS Formulation E, 54 mg xanomeline)
arm
name: High-dose xanomeline arm
type: C174266 (ncimeta.nci.nih.gov#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: Primary (ResearchStudyObjectiveType#primary)
objective
name: To document the safety profile of the xanomeline TTS.
type: Primary (ResearchStudyObjectiveType#primary)
objective
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: Secondary (ResearchStudyObjectiveType#secondary)
objective
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: Secondary (ResearchStudyObjectiveType#secondary)
objective
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: Secondary (ResearchStudyObjectiveType#secondary)
objective
name: To assess the treatment response as a function of Apo E genotype.
type: Secondary (ResearchStudyObjectiveType#secondary)
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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