0.1.1 - ci-build
ScheduleOfActivityIG - Local Development build (v0.1.1). See the Directory of published versions
Generated Narrative
identifier: id: H2Q-MC-LZZT (USUAL), id: NCTA12313212 (OFFICIAL), PLAC: NCTA12313212 (SECONDARY), PUBCHEM: 60809
title: Safety and Efficacy of the Xanomeline Transdermal Therapeutic System (TTS) in Patients with Mild to Moderate Alzheimer’s Disease
status: completed
primaryPurposeType: treatment
phase: phase-3
category: Interventional Study, Randomized Clinical Trial, Double Blind Study, Placebo Control, Parallel Study
focus: Xanomeline, Transdermal Patch Dosage Form, Effects of xanomeline, a selective muscarinic receptor agonist, on cognitive function and behavioral symptoms in Alzheimer disease
condition: Alzheimer's Disease (Disorder)
contact: Bob James, Ph.D.: ph: 555-555-5555(WORK)
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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
enrollment:
sponsor: Generated Summary: id: Eli Lilly and Company (OFFICIAL); crs
principalInvestigator: Generated Summary: UPIN: ABC123 (OFFICIAL); active; Samuel Home ; Phone: 555-123-5467; gender: male
reasonStopped: accrual-goal-met
arm
name: Placebo
type: C49648
description: Placebo arm
arm
name: Low-dose xanomeline arm
type: C174266
description: Low-dose xanomeline arm (50 cm2 TTS Formulation E, 54 mg xanomeline)
arm
name: High-dose xanomeline arm
type: 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
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