{"STUDYID":"CDISCPILOT01","DOMAIN":"TI","IETESTCD":"INCL01","IETEST":"Males and postmenopausal females at least 50 years of age.","IECAT":"INCLUSION"}
{"STUDYID":"CDISCPILOT01","DOMAIN":"TI","IETESTCD":"INCL02","IETEST":"Diagnosis of probable AD as defined by NINCDS and the ADRDA guidelines (Protocol Attachment LZZT.7).","IECAT":"INCLUSION"}
{"STUDYID":"CDISCPILOT01","DOMAIN":"TI","IETESTCD":"INCL03","IETEST":"MMSE score of 10 to 23.","IECAT":"INCLUSION"}
{"STUDYID":"CDISCPILOT01","DOMAIN":"TI","IETESTCD":"INCL04","IETEST":"Modified Hachinski Ischemic Scale score of <= 4. (Protocol Attachment LZZT.8).","IECAT":"INCLUSION"}
{"STUDYID":"CDISCPILOT01","DOMAIN":"TI","IETESTCD":"INCL05","IETEST":"CNS imaging (CT scan or MRI of brain) compatible with AD within past 1 year.","IECAT":"INCLUSION"}
{"STUDYID":"CDISCPILOT01","DOMAIN":"TI","IETESTCD":"INCL06","IETEST":"Investigator has obtained informed consent signed by the patient (and/or legal representative) and by the caregiver.","IECAT":"INCLUSION"}
{"STUDYID":"CDISCPILOT01","DOMAIN":"TI","IETESTCD":"INCL07","IETEST":"Geographic proximity to investigator's site that allows adequate follow-up.","IECAT":"INCLUSION"}
{"STUDYID":"CDISCPILOT01","DOMAIN":"TI","IETESTCD":"INCL08","IETEST":"Caregiverwill monitor administration of prescribed medications, and will be responsible for the overall care of the patient at home.","IECAT":"INCLUSION"}
{"STUDYID":"CDISCPILOT01","DOMAIN":"TI","IETESTCD":"EXCL09","IETEST":"Persons who have previously completed or withdrawn from this study or any other investigating xanomeline TTS or the oral formulation of xanomeline.","IECAT":"EXCLUSION"}
{"STUDYID":"CDISCPILOT01","DOMAIN":"TI","IETESTCD":"EXCL10","IETEST":"Use of any investigational agent or approved Alzheimer's therapeutic medication within 30 days prior to enrollment into the study.","IECAT":"EXCLUSION"}
{"STUDYID":"CDISCPILOT01","DOMAIN":"TI","IETESTCD":"EXCL11","IETEST":"Serious illness which required hospitalization within 3 months of screening.","IECAT":"EXCLUSION"}
{"STUDYID":"CDISCPILOT01","DOMAIN":"TI","IETESTCD":"EXCL12","IETEST":"Diagnosis of serious neurological conditions.","IECAT":"EXCLUSION"}
{"STUDYID":"CDISCPILOT01","DOMAIN":"TI","IETESTCD":"EXCL13","IETEST":"Episode of depression meeting DSM-IV criteria within 3 months of screening.","IECAT":"EXCLUSION"}
{"STUDYID":"CDISCPILOT01","DOMAIN":"TI","IETESTCD":"EXCL14","IETEST":"A history of mental illness within the last 5 years.","IECAT":"EXCLUSION"}
{"STUDYID":"CDISCPILOT01","DOMAIN":"TI","IETESTCD":"EXCL15","IETEST":"A history of syncope within the last 5 years.","IECAT":"EXCLUSION"}
{"STUDYID":"CDISCPILOT01","DOMAIN":"TI","IETESTCD":"EXCL16","IETEST":"Evidence from ECG recording at screening of any listed condition.","IECAT":"EXCLUSION"}
{"STUDYID":"CDISCPILOT01","DOMAIN":"TI","IETESTCD":"EXCL17","IETEST":"A history within the last 5 years of a serious cardiovascular disorder.","IECAT":"EXCLUSION"}
{"STUDYID":"CDISCPILOT01","DOMAIN":"TI","IETESTCD":"EXCL18","IETEST":"A history within the last 5 years of a serious gastrointestinal disorder.","IECAT":"EXCLUSION"}
{"STUDYID":"CDISCPILOT01","DOMAIN":"TI","IETESTCD":"EXCL19","IETEST":"A history within the last 5 years of a serious endocrine disorder.","IECAT":"EXCLUSION"}
{"STUDYID":"CDISCPILOT01","DOMAIN":"TI","IETESTCD":"EXCL20","IETEST":"A history within the last 5 years of a serious respiratory disorder (see list).","IECAT":"EXCLUSION"}
{"STUDYID":"CDISCPILOT01","DOMAIN":"TI","IETESTCD":"EXCL21","IETEST":"A history within the last 5 years of a serious genitourinary disorder.","IECAT":"EXCLUSION"}
{"STUDYID":"CDISCPILOT01","DOMAIN":"TI","IETESTCD":"EXCL22","IETEST":"A history within the last 5 years of a serious rheumatologic disorder.","IECAT":"EXCLUSION"}
{"STUDYID":"CDISCPILOT01","DOMAIN":"TI","IETESTCD":"EXCL23","IETEST":"A known history of human immunodeficiency virus (HIV) within the last 5 years.","IECAT":"EXCLUSION"}
{"STUDYID":"CDISCPILOT01","DOMAIN":"TI","IETESTCD":"EXCL24","IETEST":"A history within the last 5 years of a serious infectious disease (see list in protocol).","IECAT":"EXCLUSION"}
{"STUDYID":"CDISCPILOT01","DOMAIN":"TI","IETESTCD":"EXCL25","IETEST":"A history within the last 5 years of a primary or recurrent malignant disease (with exceptions, see list in protocol).","IECAT":"EXCLUSION"}
{"STUDYID":"CDISCPILOT01","DOMAIN":"TI","IETESTCD":"EXCL26","IETEST":"Visual, hearing, or communication disabilities impairing the ability to participate in the study; (for example, inability to speak or understand English, illiteracy).","IECAT":"EXCLUSION"}
{"STUDYID":"CDISCPILOT01","DOMAIN":"TI","IETESTCD":"EXCL27","IETEST":"Laboratory test values exceeding the Lilly Reference Range III for the patient's age in any of the following analytes: creatinine, total bilirubin, SGOT, SGPT, etc.","IECAT":"EXCLUSION"}
{"STUDYID":"CDISCPILOT01","DOMAIN":"TI","IETESTCD":"EXCL28","IETEST":"Central laboratory test values below reference range for folate, and vitamin B12, and outside reference range for thyroid function tests.","IECAT":"EXCLUSION"}
{"STUDYID":"CDISCPILOT01","DOMAIN":"TI","IETESTCD":"EXCL29","IETEST":"Positive syphilis screening with confirmatory testing.","IECAT":"EXCLUSION"}
{"STUDYID":"CDISCPILOT01","DOMAIN":"TI","IETESTCD":"EXCL30","IETEST":"Central laboratory test value above reference range for glycosylated hemoglobin (A1C) (insulin dependent diabetes mellitus patients only).","IECAT":"EXCLUSION"}
{"STUDYID":"CDISCPILOT01","DOMAIN":"TI","IETESTCD":"EXCL31","IETEST":"Treatment with medications within 1 month prior to enrollment (see list).","IECAT":"EXCLUSION"}