{"STUDYID":"CDISCPILOT01","DOMAIN":"TS","TSSEQ":1,"TSPARMCD":"ADDON","TSPARM":"Added on to Existing Treatments","TSVAL":"Y"}
{"STUDYID":"CDISCPILOT01","DOMAIN":"TS","TSSEQ":1,"TSPARMCD":"AGEMAX","TSPARM":"Planned Maximum Age of Subjects","TSVAL":"No maximum"}
{"STUDYID":"CDISCPILOT01","DOMAIN":"TS","TSSEQ":1,"TSPARMCD":"AGEMIN","TSPARM":"Planned Minimum Age of Subjects","TSVAL":"50 years"}
{"STUDYID":"CDISCPILOT01","DOMAIN":"TS","TSSEQ":1,"TSPARMCD":"AGESPAN","TSPARM":"Age Group","TSVAL":"ADULT (18-65)"}
{"STUDYID":"CDISCPILOT01","DOMAIN":"TS","TSSEQ":2,"TSPARMCD":"AGESPAN","TSPARM":"Age Group","TSVAL":"ELDERLY (> 65)"}
{"STUDYID":"CDISCPILOT01","DOMAIN":"TS","TSSEQ":1,"TSPARMCD":"TBLIND","TSPARM":"Trial Blinding Schema","TSVAL":"DOUBLE BLIND"}
{"STUDYID":"CDISCPILOT01","DOMAIN":"TS","TSSEQ":1,"TSPARMCD":"COMPTRT","TSPARM":"Comparative Treatment Name","TSVAL":"Placebo"}
{"STUDYID":"CDISCPILOT01","DOMAIN":"TS","TSSEQ":1,"TSPARMCD":"TCNTRL","TSPARM":"Control Type","TSVAL":"PLACEBO"}
{"STUDYID":"CDISCPILOT01","DOMAIN":"TS","TSSEQ":1,"TSPARMCD":"TDIGRP","TSPARM":"Diagnosis Group","TSVAL":"Patients with Probable Mild to Moderate Alzheimer's Disease"}
{"STUDYID":"CDISCPILOT01","DOMAIN":"TS","TSSEQ":1,"TSPARMCD":"DOSE","TSPARM":"Dose per Administration","TSVAL":"54"}
{"STUDYID":"CDISCPILOT01","DOMAIN":"TS","TSSEQ":2,"TSPARMCD":"DOSE","TSPARM":"Dose per Administration","TSVAL":"81"}
{"STUDYID":"CDISCPILOT01","DOMAIN":"TS","TSSEQ":1,"TSPARMCD":"DOSFRQ","TSPARM":"Dosing Frequency","TSVAL":"QD; 12 to 14 hours transdermal application"}
{"STUDYID":"CDISCPILOT01","DOMAIN":"TS","TSSEQ":1,"TSPARMCD":"DOSU","TSPARM":"Dose Units","TSVAL":"mg"}
{"STUDYID":"CDISCPILOT01","DOMAIN":"TS","TSSEQ":1,"TSPARMCD":"INDIC","TSPARM":"Trial Indication","TSVAL":"Mild to Moderate Alzheimer's Disease"}
{"STUDYID":"CDISCPILOT01","DOMAIN":"TS","TSSEQ":1,"TSPARMCD":"TINDTP","TSPARM":"Trial Indication Type","TSVAL":"TREATMENT"}
{"STUDYID":"CDISCPILOT01","DOMAIN":"TS","TSSEQ":1,"TSPARMCD":"LENGTH","TSPARM":"Trial Length","TSVAL":"26 weeks"}
{"STUDYID":"CDISCPILOT01","DOMAIN":"TS","TSSEQ":1,"TSPARMCD":"OBJPRIM","TSPARM":"Trial Primary Objective","TSVAL":"To determine if there is a statistically significant relationship between the change in both ADAS-Cog and CIBIC+ scores, and drug dose (0, 50 cm2 [54 mg], and 75 cm2 [81 mg])"}
{"STUDYID":"CDISCPILOT01","DOMAIN":"TS","TSSEQ":2,"TSPARMCD":"OBJPRIM","TSPARM":"Trial Primary Objective","TSVAL":"To document the safety profile of the xanomeline TTS."}
{"STUDYID":"CDISCPILOT01","DOMAIN":"TS","TSSEQ":1,"TSPARMCD":"OBJSEC","TSPARM":"Trial Secondary Objective","TSVAL":"To assess the dose-dependent improvement in behavior. Improved scores on the Revised Neuropsychiatric Inventory (NPI-X) will indicate improvement in these areas."}
{"STUDYID":"CDISCPILOT01","DOMAIN":"TS","TSSEQ":2,"TSPARMCD":"OBJSEC","TSPARM":"Trial Secondary Objective","TSVAL":"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."}
{"STUDYID":"CDISCPILOT01","DOMAIN":"TS","TSSEQ":3,"TSPARMCD":"OBJSEC","TSPARM":"Trial Secondary Objective","TSVAL":"To assess the dose-dependent improvements in an extended assessment of cognition that integrates attention/concentration tasks. The ADAS-Cog (14) will be used for this assessment."}
{"STUDYID":"CDISCPILOT01","DOMAIN":"TS","TSSEQ":4,"TSPARMCD":"OBJSEC","TSPARM":"Trial Secondary Objective","TSVAL":"To assess the treatment response as a function of Apo E genotype."}
{"STUDYID":"CDISCPILOT01","DOMAIN":"TS","TSSEQ":1,"TSPARMCD":"TPHASE","TSPARM":"Trial Phase Classification","TSVAL":"Phase II Trial"}
{"STUDYID":"CDISCPILOT01","DOMAIN":"TS","TSSEQ":1,"TSPARMCD":"PLANSUB","TSPARM":"Planned Number of Subjects","TSVAL":"300"}
{"STUDYID":"CDISCPILOT01","DOMAIN":"TS","TSSEQ":1,"TSPARMCD":"RANDOM","TSPARM":"Trial is Randomized","TSVAL":"Y"}
{"STUDYID":"CDISCPILOT01","DOMAIN":"TS","TSSEQ":1,"TSPARMCD":"ROUTE","TSPARM":"Route of Administration","TSVAL":"TRANSDERMAL"}
{"STUDYID":"CDISCPILOT01","DOMAIN":"TS","TSSEQ":1,"TSPARMCD":"SEXPOP","TSPARM":"Sex of Participants","TSVAL":"BOTH"}
{"STUDYID":"CDISCPILOT01","DOMAIN":"TS","TSSEQ":1,"TSPARMCD":"SPONSOR","TSPARM":"Clinical Study Sponsor","TSVAL":"CDISCPILOT01"}
{"STUDYID":"CDISCPILOT01","DOMAIN":"TS","TSSEQ":1,"TSPARMCD":"TITLE","TSPARM":"Trial Title","TSVAL":"Safety and Efficacy of the Xanomeline Transdermal Therapeutic System (TTS) in Patients with Mild to Moderate Alzheimer's Disease."}
{"STUDYID":"CDISCPILOT01","DOMAIN":"TS","TSSEQ":1,"TSPARMCD":"TRT","TSPARM":"Investigational Therapy or Treatment","TSVAL":"Xanomeline"}
{"STUDYID":"CDISCPILOT01","DOMAIN":"TS","TSSEQ":1,"TSPARMCD":"TTYPE","TSPARM":"Trial Type","TSVAL":"SAFETY"}
{"STUDYID":"CDISCPILOT01","DOMAIN":"TS","TSSEQ":2,"TSPARMCD":"TTYPE","TSPARM":"Trial Type","TSVAL":"EFFICACY"}
{"STUDYID":"CDISCPILOT01","DOMAIN":"TS","TSSEQ":4,"TSPARMCD":"TTYPE","TSPARM":"Trial Type","TSVAL":"PHARMACOKINETIC"}