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2502","Cambridge","CB21 5EF",{"type":58,"coordinates":1683},[1684,1685],0.11667,52.2,{"lat":1685,"lon":1684},[1688],{"name":1689,"role":43,"phone":11,"phoneExt":11,"email":11},"Site 2502",{"facility":1691,"status":51,"city":1692,"state":11,"zip":1693,"country":1653,"countryCode":1654,"cosmosGeoPoint":1694,"geoPoint":1698,"contacts":1699},"South London and Maudsley NHS Foundation Trust","London","SE5 8AZ",{"type":58,"coordinates":1695},[1696,1697],-0.12574,51.50853,{"lat":1697,"lon":1696},[1700],{"name":1701,"role":43,"phone":1702,"phoneExt":11,"email":11},"Dag Aarsland, Site 2501","+44 800 731 2864",{"facility":1704,"status":69,"city":1692,"state":11,"zip":1705,"country":1653,"countryCode":1654,"cosmosGeoPoint":1706,"geoPoint":1708,"contacts":1709},"Local Institution - 2500","W12 0NN",{"type":58,"coordinates":1707},[1696,1697],{"lat":1697,"lon":1696},[1710],{"name":1711,"role":43,"phone":11,"phoneExt":11,"email":11},"Site 2500",{"facility":1713,"status":51,"city":1714,"state":11,"zip":1715,"country":1653,"countryCode":1654,"cosmosGeoPoint":1716,"geoPoint":1720,"contacts":1721},"NeuroClin Glasgow","Motherwell","ML1 4UF",{"type":58,"coordinates":1717},[1718,1719],-3.99187,55.78924,{"lat":1719,"lon":1718},[1722],{"name":1723,"role":43,"phone":1724,"phoneExt":11,"email":11},"Jennifer Lynch, Site 2510","+44 141 948 0206",{"facility":1726,"status":51,"city":1727,"state":11,"zip":1728,"country":1653,"countryCode":1654,"cosmosGeoPoint":1729,"geoPoint":1733,"contacts":1734},"Cornwall Partnership NHS Foundation Trust","Redruth","TR15 3QE",{"type":58,"coordinates":1730},[1731,1732],-5.22434,50.23315,{"lat":1732,"lon":1731},[1735],{"name":1736,"role":43,"phone":1737,"phoneExt":11,"email":11},"Nicholas Jacobsen, Site 2507","+44 1208 251 300",{"facility":1739,"status":51,"city":1740,"state":11,"zip":1741,"country":1653,"countryCode":1654,"cosmosGeoPoint":1742,"geoPoint":1746,"contacts":1747},"Sheffield Health and Social care NHS Foundation Trust","Sheffield","S5 7JT",{"type":58,"coordinates":1743},[1744,1745],-1.4659,53.38297,{"lat":1745,"lon":1744},[1748],{"name":1749,"role":43,"phone":1750,"phoneExt":11,"email":11},"Aparna Mordekar, Site 2504","+44 114 226 1600",{"facility":1752,"status":180,"city":1753,"state":11,"zip":1754,"country":1653,"countryCode":1654,"cosmosGeoPoint":1755,"geoPoint":1759,"contacts":11},"Local Institution - 2509","Stafford","ST16 3SR",{"type":58,"coordinates":1756},[1757,1758],-2.11636,52.80521,{"lat":1758,"lon":1757},{"facility":1761,"status":51,"city":1762,"state":11,"zip":1763,"country":1653,"countryCode":1654,"cosmosGeoPoint":1764,"geoPoint":1768,"contacts":1769},"Black Country Healthcare NHS Foundation Trust","Wolverhampton","WV4 5HN",{"type":58,"coordinates":1765},[1766,1767],-2.12296,52.58547,{"lat":1767,"lon":1766},[1770],{"name":1771,"role":43,"phone":1772,"phoneExt":11,"email":11},"Luay Kafienah, Site 2503","+44 1902 444141",{"type":1774,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100593846","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-2-100593846",false,"NCT07011745","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-2)","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:\n\ni) 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:\n\nA. 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 5 to 22, inclusive, at Screening (Visit 1).\n  * Have one identified caregiver who should have sufficient contact (approximately 10 hours a week or more) and is willing to:\n\n    i) Attend all visits and report on participant's status.\n\nii) Oversee participant compliance with medication and study procedures.\n\niii) Participate in the study assessments and provide informed consent to participate in the study.\n\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* CGI-S ≥ 4, as related to agitation, at Screening (Visit 1) and Baseline (Visit 2).\n* At least 1 of the following 3 criteria must be established from the CMAI-IPA at Screening (Visit 1) and Baseline (Visit 2; CMAI-IPA Physical\u002FVerbal Aggression Positivity):\n\n  i) 1 or more aggressive behaviors occurring at least several times per week.\n\nii) 2 or more aggressive behaviors occurring at least once or twice per week.\n\niii) 3 or more aggressive behaviors occurring less than once per week.\n\nExclusion Criteria\n\n\\- Medical Conditions.\n\ni) 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.\n\niii) 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.\n\ni) 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. Mirtazapine or trazodone 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":1786,"type":1787},352,"ESTIMATED","INTERVENTIONAL",[1790],"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.",[1793],"Alzheimer Disease","2026-06-24",{"date":1796,"type":1797},"2026-06-25","ACTUAL",{"date":1799,"type":1797},"2025-07-16",{"date":1801,"type":1787},"2028-11-13",{"name":5,"class":6},145]