<protocol> <reference value="PlanDefinition/H2Q-MC-LZZT-ProtocolDesign"/> </protocol> <status value="retired"/> <primaryPurposeType> <coding> <system value="http://terminology.hl7.org/CodeSystem/research-study-prim-purp-type"/> <code value="treatment"/> </coding> </primaryPurposeType> <phase> <coding> <system value="http://terminology.hl7.org/CodeSystem/research-study-phase"/> <code value="phase-3"/> </coding> </phase> <condition> <coding> <system value="http://snomed.info/sct"/> <code value="26929004"/> <display value="Alzheimer's Disease (Disorder)"/> </coding> </condition> <keyword> <coding> <system value="https://www.nlm.nih.gov/mesh"/> <code value="D018721"/> </coding> <text value="Selective M1 muscarinic agonists"/> </keyword> <keyword> <coding> <system value="https://www.nlm.nih.gov/mesh"/> <code value="D000544"/> </coding> <text value="Alzheimer Disease"/> </keyword> <keyword> <coding> <system value="https://www.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"/> <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> <system value="http://terminology.hl7.org/CodeSystem/research-study-objective-type"/> <code value="primary"/> </coding> </type> </objective> <objective> <name value="To document the safety profile of the xanomeline TTS."/> <type> <coding> <system value="http://terminology.hl7.org/CodeSystem/research-study-objective-type"/> <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> <system value="http://terminology.hl7.org/CodeSystem/research-study-objective-type"/> <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> <system value="http://terminology.hl7.org/CodeSystem/research-study-objective-type"/> <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> <system value="http://terminology.hl7.org/CodeSystem/research-study-objective-type"/> <code value="secondary"/> </coding> </type> </objective> <objective> <name value="To assess the treatment response as a function of Apo E genotype."/> <type> <coding> <system value="http://terminology.hl7.org/CodeSystem/research-study-objective-type"/> <code value="secondary"/> </coding> </type> </objective> </ResearchStudy>

Generated Narrative: ResearchStudy H2Q-MC-LZZT-ResearchStudy

Language: en

identifier: H2Q-MC-LZZT (use: usual, ), https://clinicaltrials.gov/show//NCTA12313212 (use: official, ), 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)

Protocol H2Q-MC-LZZT(c)

Safety 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: 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