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CDISC PILOT - LZZT

Status & Metadata
Source Method : Publicly Available
Source URL: Link
Generation Method : Unknown
Date Added: 16 Jun 2026
Contributor: System
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Additional Resources
Protocol
Date Added: 16 Jun 2026
CDISC CORE Conformance
Conformance assessed
SUCCESS 200
EXECUTION_ERROR 1
SKIPPED 6
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Rationale

The discontinuation rate associated with this oral dosing regimen was 58.6% in previous studies, and alternative clinical strategies have been sought to improve tolerance for the compound. To that end, development of a Transdermal Therapeutic System (TTS) has been initiated.

Key Metrics

Interventional Study
Phase II Trial
2
N/A

Important Dates

Event Date
Design Approval 01 Jun 2006

Schedule of Activities: Study Design 1

Timeline: Main Timeline
Visit / Timing Interval Window Activities
Screening
TIM1 		2 weeks No window
  • Patient randomised
  • Vital Signs and Temperature
  • Ambulatory ECG removed
  • Concomitant medications
  • Plasma Specimen (Xanomeline)
  • Study drug record , Medications dispensed, Medications returned
  • ADAS-Cog
  • CIBIC+
  • DAD
  • NPI-X
Pre dose
TIM2 		2 days -4..0 hours
  • Patient randomised
  • Vital Signs and Temperature
  • Ambulatory ECG removed
  • Concomitant medications
  • Plasma Specimen (Xanomeline)
  • Study drug record , Medications dispensed, Medications returned
  • ADAS-Cog
  • CIBIC+
  • DAD
  • NPI-X
Dosing
TIM3 		1 Day No window
  • Patient randomised
  • Vital Signs and Temperature
  • Ambulatory ECG removed
  • Concomitant medications
  • Plasma Specimen (Xanomeline)
  • Study drug record , Medications dispensed, Medications returned
  • ADAS-Cog
  • CIBIC+
  • DAD
  • NPI-X
Week 2
TIM4 		2 Weeks -3..3 days
  • Patient randomised
  • Vital Signs and Temperature
  • Ambulatory ECG removed
  • Concomitant medications
  • Plasma Specimen (Xanomeline)
  • Study drug record , Medications dispensed, Medications returned
  • ADAS-Cog
  • CIBIC+
  • DAD
  • NPI-X
Week 4
TIM5 		4 Weeks -3..3 days
  • Patient randomised
  • Vital Signs and Temperature
  • Ambulatory ECG removed
  • Concomitant medications
  • Plasma Specimen (Xanomeline)
  • Study drug record , Medications dispensed, Medications returned
  • ADAS-Cog
  • CIBIC+
  • DAD
  • NPI-X
Week 6
TIM6 		6 Weeks -3..3 days
  • Patient randomised
  • Vital Signs and Temperature
  • Ambulatory ECG removed
  • Concomitant medications
  • Plasma Specimen (Xanomeline)
  • Study drug record , Medications dispensed, Medications returned
  • ADAS-Cog
  • CIBIC+
  • DAD
  • NPI-X
Week 8
TIM7 		8 Weeks -3..3 days
  • Patient randomised
  • Vital Signs and Temperature
  • Ambulatory ECG removed
  • Concomitant medications
  • Plasma Specimen (Xanomeline)
  • Study drug record , Medications dispensed, Medications returned
  • ADAS-Cog
  • CIBIC+
  • DAD
  • NPI-X
Week 12
TIM9 		12 Weeks -4..4 days
  • Patient randomised
  • Vital Signs and Temperature
  • Ambulatory ECG removed
  • Concomitant medications
  • Plasma Specimen (Xanomeline)
  • Study drug record , Medications dispensed, Medications returned
  • ADAS-Cog
  • CIBIC+
  • DAD
  • NPI-X
Week 16
TIM11 		16 Weeks -4..4 days
  • Patient randomised
  • Vital Signs and Temperature
  • Ambulatory ECG removed
  • Concomitant medications
  • Plasma Specimen (Xanomeline)
  • Study drug record , Medications dispensed, Medications returned
  • ADAS-Cog
  • CIBIC+
  • DAD
  • NPI-X
Week 20
TIM13 		20 Weeks -4..4 days
  • Patient randomised
  • Vital Signs and Temperature
  • Ambulatory ECG removed
  • Concomitant medications
  • Plasma Specimen (Xanomeline)
  • Study drug record , Medications dispensed, Medications returned
  • ADAS-Cog
  • CIBIC+
  • DAD
  • NPI-X
Week 24
TIM15 		24 Weeks -4..4 days
  • Patient randomised
  • Vital Signs and Temperature
  • Ambulatory ECG removed
  • Concomitant medications
  • Plasma Specimen (Xanomeline)
  • Study drug record , Medications dispensed, Medications returned
  • ADAS-Cog
  • CIBIC+
  • DAD
  • NPI-X
Week 26
TIM16 		26 Weeks -3..3 days
  • Patient randomised
  • Vital Signs and Temperature
  • Ambulatory ECG removed
  • Concomitant medications
  • Plasma Specimen (Xanomeline)
  • Study drug record , Medications dispensed, Medications returned
  • ADAS-Cog
  • CIBIC+
  • DAD
  • NPI-X
Week 8 Home
TIM8 		2 Weeks No window
  • Vital Signs and Temperature
  • ECG
  • Concomitant medications
  • Hematology
  • Chemistry
  • Study drug record , Medications dispensed, Medications returned
  • ADAS-Cog
  • CIBIC+
  • DAD
  • NPI-X
Week 12 Home
TIM10 		2 Weeks No window
  • Vital Signs and Temperature
  • ECG
  • Concomitant medications
  • Hematology
  • Chemistry
  • Uninalysis
  • Plasma Specimen (Xanomeline)
  • Study drug record , Medications dispensed, Medications returned
  • NPI-X
Week 16 Home
TIM12 		2 Weeks No window
  • Vital Signs and Temperature
  • ECG
  • Concomitant medications
  • Hematology
  • Chemistry
  • Study drug record , Medications dispensed, Medications returned
  • ADAS-Cog
  • CIBIC+
  • DAD
  • NPI-X
Week 16 Home decision
TIM12b 		0 Days No window
  • Vital Signs and Temperature
  • ECG
  • Concomitant medications
  • Hematology
  • Chemistry
  • Study drug record , Medications dispensed, Medications returned
  • ADAS-Cog
  • CIBIC+
  • DAD
  • NPI-X
Week 20 Home
TIM14 		2 Weeks No window
  • Vital Signs and Temperature
  • ECG
  • Concomitant medications
  • Hematology
  • Chemistry
  • Plasma Specimen (Xanomeline)
  • Study drug record , Medications dispensed, Medications returned
  • NPI-X
Timeline: Adverse Event Timeline
Visit / Timing Interval Window Activities
Adverse Event
TIM17 		1 Day No window
  • Adverse events
Timeline: Early Termination Timeline
Visit / Timing Interval Window Activities
Early Termination
TIM18 		1 Day No window
  • Physical examination
  • Vital Signs and Temperature
  • ECG
  • Concomitant medications
  • Hematology
  • Chemistry
  • Uninalysis
  • Plasma Specimen (Xanomeline)
  • Study drug record , Medications dispensed, Medications returned
  • TTS Acceptability Survey
  • ADAS-Cog
  • CIBIC+
  • DAD
  • NPI-X
  • Check adverse events
Timeline: Vital Sign Blood Pressure Timeline
Visit / Timing Interval Window Activities
Supine
TIM19 		0 mins No window
  • Subject supine
VS while supine
TIM20 		5 mins No window
  • Subject supine
Standing
TIM21 		0 min No window
  • Vital signs while supine
VS while standing
TIM22 		1 min No window
  • Subject Standing
Standing
TIM23 		0 min No window
  • Vital signs while standing
VS while standing
TIM24 		2 min No window
  • Subject Standing