Generated Narrative

type: person

actual: false

characteristic

code: Persons who have previously completed or withdrawn from this study or any other study investigating xanomeline TTS or the oral formulation of xanomeline.

value: true

exclude: true

characteristic

code: Use of any investigational agent or approved Alzheimer’s therapeutic medication within 30 days prior to enrollment into the study.

value: true

exclude: true

characteristic

code: Serious illness which required hospitalization within 3 months of screening.

value: true

exclude: true

characteristic

code: Stroke or vascular dementia documented by clinical history and/or radiographic findings interpretable by the investigator as indicative of these disorders

value: true

exclude: true

characteristic

code: Seizure disorder other than simple childhood febrile seizures

value: true

exclude: true

characteristic

code: Severe head trauma resulting in protracted loss of consciousness within the last 5 years, or multiple episodes of head trauma

value: true

exclude: true

characteristic

code: Parkinson’s disease

value: true

exclude: true

characteristic

code: Multiple sclerosis

value: true

exclude: true

characteristic

code: Amyotrophic lateral sclerosis

value: true

exclude: true

characteristic

code: Myasthenia gravis

value: true

exclude: true

characteristic

code: Episode of depression meeting DSM-IV criteria within 3 months of screening.

value: true

exclude: true

characteristic

code: A history within the last 5 years of Schizophrenia.

value: true

exclude: true

characteristic

code: A history within the last 5 years of Bipolar Disease.

value: true

exclude: true

characteristic

code: A history within the last 5 years of Ethanol or psychoactive drug abuse or dependence.

value: true

exclude: true

characteristic

code: A history of syncope within the last 5 years.

value: true

exclude: true

characteristic

code: Evidence from ECG recording of Left bundle branch block.

value: true

exclude: true

characteristic

code: Evidence from ECG recording of Bradycardia ≤50 beats per minute

value: true

exclude: true

characteristic

code: Evidence from ECG recording of Sinus pauses >2 seconds

value: true

exclude: true

characteristic

code: Evidence from ECG recording of Second or third degree heart block unless treated with a pacemaker

value: true

exclude: true

characteristic

code: Evidence from ECG recording of Wolff-Parkinson-White syndrome

value: true

exclude: true

characteristic

code: Evidence from ECG recording of Sustained supraventricular tachyarrhythmia including SVT≥10 sec, atrial fibrillation, atrial flutter.

value: true

exclude: true

characteristic

code: Evidence from ECG recording of Ventricular tachycardia at a rate of ≥120 beats per minute lasting ≥10 seconds.

value: true

exclude: true

characteristic

code: A history within the last 5 years of Clinically significant arrhythmia

value: true

exclude: true

characteristic

code: A history within the last 5 years of Symptomatic sick sinus syndrome not treated with a pacemaker

value: true

exclude: true

characteristic

code: A history within the last 5 years of Congestive heart failure refractory to treatment

value: true

exclude: true

characteristic

code: A history within the last 5 years of Angina except angina controlled with PRN nitroglycerin

value: true

exclude: true

characteristic

code: A history within the last 5 years of Resting heart rate <50 or >100 beats per minute, on physical exam

value: true

exclude: true

characteristic

code: A history within the last 5 years of Uncontrolled hypertension.

value: true

exclude: true

characteristic

code: A history within the last 5 years of a serious gastrointestinal disorder

value: true

exclude: true