{ "resourceType" : "ResearchStudy", "id" : "H2Q-MC-LZZT-ResearchStudy", "meta" : { "profile" : ["http://hl7.org/fhir/uv/vulcan-schedule/StructureDefinition/ResearchStudySoa"] }, "language" : "en", "text" : { "status" : "generated", "div" : "

Generated Narrative: ResearchStudy H2Q-MC-LZZT-ResearchStudy

Language: en

Profile: ResearchStudySoa

identifier: H2Q-MC-LZZT\u00a0(use:\u00a0usual,\u00a0), https://clinicaltrials.gov/show//NCTA12313212\u00a0(use:\u00a0official,\u00a0), 60809

title: Safety and Efficacy of the Xanomeline Transdermal Therapeutic System (TTS) in Patients with Mild to Moderate Alzheimer’s Disease

protocol: H2Q-MC-LZZT Protocol Schedule of Activities

status: Retired

primaryPurposeType: Treatment

phase: Phase 3

condition: Alzheimer's Disease (Disorder)

keyword: Selective M1 muscarinic agonists, Alzheimer Disease, Selective M1 muscarinic agonists

description:

Xanomeline (LY246708)

\n

Protocol H2Q-MC-LZZT(c)

\n

Safety and Efficacy of the Xanomeline Transdermal Therapeutic System (TTS) in Patients with Mild to Moderate Alzheimer’s Disease

\n

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

objective

name: To document the safety profile of the xanomeline TTS.

type: 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

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

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

objective

name: To assess the treatment response as a function of Apo E genotype.

type: Secondary

" }, "identifier" : [{ "use" : "usual", "value" : "H2Q-MC-LZZT" }, { "use" : "official", "system" : "https://clinicaltrials.gov/show/", "value" : "NCTA12313212" }, { "value" : "60809" }], "title" : "Safety and Efficacy of the Xanomeline Transdermal Therapeutic System (TTS) in Patients with Mild to Moderate Alzheimer’s Disease", "protocol" : [{ "reference" : "PlanDefinition/H2Q-MC-LZZT-ProtocolDesign" }], "status" : "retired", "primaryPurposeType" : { "coding" : [{ "system" : "http://terminology.hl7.org/CodeSystem/research-study-prim-purp-type", "code" : "treatment" }] }, "phase" : { "coding" : [{ "system" : "http://terminology.hl7.org/CodeSystem/research-study-phase", "code" : "phase-3" }] }, "condition" : [{ "coding" : [{ "system" : "http://snomed.info/sct", "code" : "26929004", "display" : "Alzheimer's Disease (Disorder)" }] }], "keyword" : [{ "coding" : [{ "system" : "https://www.nlm.nih.gov/mesh", "code" : "D018721" }], "text" : "Selective M1 muscarinic agonists" }, { "coding" : [{ "system" : "https://www.nlm.nih.gov/mesh", "code" : "D000544" }], "text" : "Alzheimer Disease" }, { "coding" : [{ "system" : "https://www.nlm.nih.gov/mesh", "code" : "D018721" }], "text" : "Selective M1 muscarinic agonists" }], "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", "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" : [{ "system" : "http://terminology.hl7.org/CodeSystem/research-study-objective-type", "code" : "primary" }] } }, { "name" : "To document the safety profile of the xanomeline TTS.", "type" : { "coding" : [{ "system" : "http://terminology.hl7.org/CodeSystem/research-study-objective-type", "code" : "primary" }] } }, { "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", "code" : "secondary" }] } }, { "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" : [{ "system" : "http://terminology.hl7.org/CodeSystem/research-study-objective-type", "code" : "secondary" }] } }, { "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" }] } }] }