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1500","+34639754620",{"facility":1822,"status":51,"city":1823,"state":11,"zip":1824,"country":1736,"countryCode":1737,"cosmosGeoPoint":1825,"geoPoint":1829,"contacts":1830},"Hospital Victoria Eugenia de Sevilla","Seville","41009",{"type":58,"coordinates":1826},[1827,1828],-5.97317,37.38283,{"lat":1828,"lon":1827},[1831],{"name":1832,"role":43,"phone":1833,"phoneExt":11,"email":11},"Felix Vinuela Fernandez, Site 1503","+34654566812",{"facility":1835,"status":51,"city":1836,"state":11,"zip":1837,"country":1736,"countryCode":1737,"cosmosGeoPoint":1838,"geoPoint":1842,"contacts":1843},"Hospital Mutua Terrassa","Terrassa","8221",{"type":58,"coordinates":1839},[1840,1841],2.01667,41.56667,{"lat":1841,"lon":1840},[1844],{"name":1845,"role":43,"phone":1846,"phoneExt":11,"email":11},"Jerzy Krupinski, Site 1504","+34937365050ext13939",{"facility":1848,"status":51,"city":1849,"state":11,"zip":1850,"country":1736,"countryCode":1737,"cosmosGeoPoint":1851,"geoPoint":1855,"contacts":1856},"Hospital Universitario De Rio Hortega","Valladolid","47012",{"type":58,"coordinates":1852},[1853,1854],-4.72353,41.65541,{"lat":1854,"lon":1853},[1857],{"name":1858,"role":43,"phone":1859,"phoneExt":11,"email":11},"Juan Muñoz Sanchez, Site 1506","+34679279973",{"facility":1861,"status":51,"city":1862,"state":11,"zip":1863,"country":1736,"countryCode":1737,"cosmosGeoPoint":1864,"geoPoint":1868,"contacts":1869},"Hospital Viamed Montecanal","Zaragoza","50012",{"type":58,"coordinates":1865},[1866,1867],-0.87734,41.65606,{"lat":1867,"lon":1866},[1870],{"name":1871,"role":43,"phone":1872,"phoneExt":11,"email":11},"Antonio Oliveros-Cid, Site 1501","+34670492099",{"facility":1874,"status":51,"city":1875,"state":1876,"zip":1877,"country":1878,"countryCode":1879,"cosmosGeoPoint":11,"geoPoint":11,"contacts":1880},"Chang Gung Memorial Hospital at Kaohsiung","Kaohsiung Niao Sung Dist","Kaohsiung","83301","Taiwan","TW",[1881],{"name":1882,"role":43,"phone":11,"phoneExt":11,"email":11},"Chiung-Chih Chang, Site 1753",{"facility":1884,"status":51,"city":1885,"state":11,"zip":1886,"country":1878,"countryCode":1879,"cosmosGeoPoint":1887,"geoPoint":1891,"contacts":1892},"National Cheng Kung University Hospital","Tainan, Taiana","704",{"type":58,"coordinates":1888},[1889,1890],120.21333,22.99083,{"lat":1890,"lon":1889},[1893],{"name":1894,"role":43,"phone":11,"phoneExt":11,"email":11},"Ming-Chyi Pai, Site 1751",{"facility":1896,"status":51,"city":1897,"state":11,"zip":1898,"country":1878,"countryCode":1879,"cosmosGeoPoint":1899,"geoPoint":1903,"contacts":1904},"National Taiwan University Hospital","Taipei","100229",{"type":58,"coordinates":1900},[1901,1902],121.52639,25.05306,{"lat":1902,"lon":1901},[1905],{"name":1906,"role":43,"phone":11,"phoneExt":11,"email":11},"Yi-Ting Lin, Site 1754",{"facility":1908,"status":51,"city":1897,"state":11,"zip":1909,"country":1878,"countryCode":1879,"cosmosGeoPoint":1910,"geoPoint":1912,"contacts":1913},"Taipei Veterans General Hospital","112",{"type":58,"coordinates":1911},[1901,1902],{"lat":1902,"lon":1901},[1914],{"name":1915,"role":43,"phone":11,"phoneExt":11,"email":11},"Jong-Ling Fuh, Site 1750",{"facility":1917,"status":51,"city":1918,"state":11,"zip":1919,"country":1878,"countryCode":1879,"cosmosGeoPoint":1920,"geoPoint":1924,"contacts":1925},"Chang Gung Medical Foundation-Linkou Branch","Taoyuan","333",{"type":58,"coordinates":1921},[1922,1923],121.29696,24.99368,{"lat":1923,"lon":1922},[1926],{"name":1927,"role":43,"phone":11,"phoneExt":11,"email":11},"Yi-chun Chen, Site 1752",{"type":1929,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100053295","phase-3-a-phase-3-study-to-evaluate-the-safety-and-efficacy-of-karxt--karx-ec-for-the-treatment-of-agitation-associated-with-alzheimers-disease-adagio-1-100053295",false,"NCT07011732","A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-1)","A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease","Inclusion Criteria\n\n\\- A diagnosis of Alzheimer's disease (AD) in accordance with the 2024 Alzheimer's Association criteria with one of the following confirmations of AD pathology: i) Historical evidence of AD diagnosis with amyloid positron emission tomography (PET), Aβ42\u002F40 ratio in CSF, pTau181\u002FAβ42 ratio in CSF or pTau217\u002FAβ42 ratio in plasma using an Health Authority (HA)-authorized diagnostic assay.\n\nii) If no historical evidence available: A. A plasma biomarker will be assessed for eligibility if allowed per regulatory requirements. The test cutoff(s) will be based on diagnostic use approval.\n\nB. If a plasma biomarker assay cannot be used or if the assay result is inconclusive, conduct one the following:\n\n* Amyloid PET.\n* Aβ42\u002F40 ratio or pTau181\u002FAβ42 ratio in CSF using an HA-authorized diagnostic assay.\n\n  * Mini-Mental State Examination (MMSE) score of ≤ 24 at Screening (Visit 1).\n  * Have an identified caregiver who has sufficient contact (approximately 8 hours over a week) and is willing to:\n\n    i) Attend all visits and report on participant's status. ii) Oversee participant compliance with medication and study procedures. iii) Participate in the study assessments and provide informed consent to participate in the study.\n  * History of agitation that meets the International Psychogeriatric Association (IPA) consensus definition for agitation in cognitive disorders with onset at least two weeks prior to Screening (Visit 1).\n  * AD participants are required to have NPI\u002FNPI-NH Agitation\u002FAggression score ≥ 4 at Screening (Visit 1) and Baseline (Visit 2).\n  * CMAI-IPA Total Score ≥ 30 at Screening (Visit 1) and Baseline (Visit 2).\n\nExclusion Criteria\n\n\\- Medical Conditions: i) Agitation symptoms that are primarily attributable to a condition other than the AD causing the dementia.\n\nii) History of bipolar disorder, schizophrenia, or schizoaffective disorder. iii) History of (or at high risk for) urinary retention, gastric retention, or narrow-angle glaucoma as evaluated by the Investigator.\n\niv) Risk of suicidal behavior during the study as determined by the Investigator's clinical assessment and\u002For C-SSR.\n\n\\- Prior\u002FConcomitant Therapy: i) Recent history of receiving monoamine oxidase inhibitors, anticonvulsants (eg, lamotrigine, divalproex), mood stabilizers (eg, lithium), tricyclic antidepressants (eg, imipramine, desipramine), or any other psychoactive medications except for as needed anxiolytics (eg, lorazepam).\n\nA. Selective serotonin reuptake inhibitors and serotonin norepinephrine reuptake inhibitors taken at a stable dose for at least 8 weeks prior to Screening (Visit 1) may be permitted.\n\nB. Trazodone may be used as a hypnotic or for agitation if started at least 8 weeks prior to Screening (Visit 1).\n\nC. Mirtazapine may be used as a hypnotic if started at least 8 weeks prior to Screening (Visit 1).\n\n\\- Other protocol-defined Inclusion\u002FExclusion criteria apply.","ALL","55 Years","90 Years",{"count":1941,"type":1942},426,"ESTIMATED","INTERVENTIONAL",[1945],"PHASE3","The purpose of this study is to evaluate the efficacy and safety of KarXT + KarX-EC in adult participants with agitation related to Alzheimer's Disease.",[1948],"Alzheimer Disease","2026-07-10",{"date":1951,"type":1952},"2026-07-13","ACTUAL",{"date":1954,"type":1952},"2025-07-10",{"date":1956,"type":1942},"2028-12-08",{"name":5,"class":6},158]