Clinical Study Schedule of Activities
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Clinical Study Schedule of Activities, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 2.0.0-ballot built by the FHIR (HL7® FHIR® Standard) CI Build. 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

Example ResearchStudy: H2Q-MC-LZZT Research Study

Page standards status: Informative

Language: en

Profile: ResearchStudySoa

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