[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100614813":3},{"organization":4,"outcomesModule":7,"designInfo":27,"detailedDescription":39,"studyPopulation":30,"armGroups":40,"interventions":58,"overallOfficials":30,"centralContacts":71,"locations":77,"responsibleParty":557,"collaborators":30,"id":559,"slug":30,"hasResults":560,"nctId":561,"briefTitle":562,"officialTitle":563,"acronym":564,"eligibilityCriteria":565,"healthyVolunteers":560,"sex":566,"minAge":567,"maxAge":568,"enrollmentInfo":569,"targetDuration":30,"studyType":572,"phases":573,"briefSummary":576,"conditions":577,"keywords":30,"overallStatus":80,"whyStopped":30,"lastUpdateSubmitDate":579,"lastUpdatePostDateStruct":580,"startDateStruct":583,"completionDateStruct":585,"leadSponsor":587,"locationsCount":588},{"fullName":5,"class":6},"Exciva GmbH","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":17},[9],{"measure":10,"description":11,"timeFrame":12},"Changes from baseline to endpoint (Week 6) in the Cohen-Mansfield Agitation Inventory - International Psychogeriatric Association (CMAI-IPA) score","The CMAI is used to assess the frequency of manifestations of agitated behaviors in elderly persons. It consists of 29 agitated behaviors that are further categorized into distinct agitation syndromes, also known as CMAI factors of agitation. These distinct agitation syndromes include aggressive behavior, physically nonaggressive behavior, and verbally agitated behavior. Each of the 29 items is rated on a 7-point scale of frequency (1 = never, 2 = less than once a week but still occurring, 3 = once or twice a week, 4 = several times a week, 5 = once or twice a day, 6 = several times a day, 7 = several times an hour). The ratings are based on the 2 weeks preceding assessment of the CMAI. Higher scores indicate higher frequency of agitated behaviors while lower scores indicate lower frequency of agitated behaviors The CMAI-IPA includes 19 items that were mapped to IPA agitation domains. The total score ranges from 19 to 133 with higher scores indicating more severity.","Baseline to Week 6",[14],{"measure":15,"description":16,"timeFrame":12},"Changes from baseline to endpoint (Week 6) in the Clinical Global Impression of Severity of Illness (CGI-S) score as related to symptoms of agitation","The CGI-S is an observer-rated scale that measures illness severity. The CGI-S is a 7-point (1-7) scale (1 = normal, not at all ill; 7 = extremely ill) that assessed the severity of agitation in this study. Higher scores indicate severe agitation, while the lower scores indicate little or no agitation.",[18,21,24],{"measure":19,"description":20,"timeFrame":12},"Changes from baseline to endpoint (Week 6) in the Neuropsychiatric Inventory - Clinician (NPI-C) Caregiver Distress score for Agitation and Aggression domains","The NPI-C is a retrospective interview covering 14 neuropsychiatric symptom domains. The NPI-C version of the NPI scale was designed to be administered by the clinician to the participant and the caregiver. The caregiver is first asked to provide frequency, severity, and distress ratings for each individual item across the domains. Frequency is rated on a scale from 0 to 4. Severity is rated on a scale from 0 to 3. Separately, the rater interviews the patient to assess frequency (0 to 4) of each item. Clinician rating of clinical impression is a severity rating (0 to 3) based on all available clinical and interview information. For this endpoint, the caregiver distress will be analyzed for the agitation and aggression domains. Caregiver distress is rated on a scale from 0 to 5 with a total score range of 0 to 10 across the 2 domains. Higher scores indicate greater caregiver distress.",{"measure":22,"description":23,"timeFrame":12},"Changes from baseline to endpoint (Week 6) in the Neuropsychiatric Inventory - Clinician (NPI-C) Irritability\u002FLiability Domain score","The NPI-C is a retrospective interview covering 14 neuropsychiatric symptom domains. The NPI-C version of the NPI scale was designed to be administered by the clinician to the participant and the caregiver. The caregiver is first asked to provide frequency, severity, and distress ratings for each individual item across the domains. Frequency is rated on a scale from 0 to 4. Severity is rated on a scale from 0 to 3. Separately, the rater interviews the patient to assess frequency (0 to 4) of each item. Clinician rating of clinical impression is a severity rating (0 to 3) based on all available clinical and interview information. The score for the irritability\u002Flability domain is the sum of clinical impression ratings of all items. There are 12 items in the irritability\u002Flability domain. The minimum score for the irritability\u002Flability domain is 0 and maximum score per domain is 36, with higher scores indicate greater symptom severity.",{"measure":25,"description":26,"timeFrame":12},"Changes from baseline to endpoint (Week 6) in the Neuropsychiatric Inventory - Clinician (NPI-C) Sleep Disorders Domain score","The NPI-C is a retrospective interview covering 14 neuropsychiatric symptom domains. The NPI-C version of the NPI scale was designed to be administered by the clinician to the participant and the caregiver. The caregiver is first asked to provide frequency, severity, and distress ratings for each individual item across the domains. Frequency is rated on a scale from 0 to 4. Severity is rated on a scale from 0 to 3. Separately, the rater interviews the patient to assess frequency (0 to 4) of each item. Clinician rating of clinical impression is a severity rating (0 to 3) based on all available clinical and interview information. The score for the sleep disorders domain is the sum of clinical impression ratings of all items. There are 8 items in the sleep disorders domain. The minimum score for the sleep disorders domain is 0 and maximum score per domain is 24, with higher scores indicate greater symptom severity.",{"allocation":28,"interventionModel":29,"interventionModelDescription":30,"primaryPurpose":31,"observationalModel":30,"timePerspective":30,"maskingInfo":32},"RANDOMIZED","PARALLEL",null,"TREATMENT",{"masking":33,"maskingDescription":30,"whoMasked":34},"QUADRUPLE",[35,36,37,38],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR","This is a Phase 2\u002F3 multicenter, double-blind, placebo-controlled, three-arm, multicenter study evaluating the safety and efficacy of EXV-802 and EXV-801 in treatment of agitation in participants with Alzheimer's Disease dementia. The diagnosis of agitation will be based on the consensus definition for agitation in patients with cognitive disorders developed by te International Psychogeriatric Association (IPA) Agitation Definition Work Group as well as neuroimaging performed after onset of dementia symptoms and a Core 1 AD biomarker.\n\nThe study will be conducted at up to 60 centers in the US, Canada and Europe.. Screening will occur within approximately 4 weeks prior to randomization. Following screening procedures for assessment of inclusion and exclusion criteria, eligible participants will be randomized into the study. Approximately 100 patients per arm will be randomized (300 total).",[41,47,53],{"label":42,"type":43,"description":44,"interventionNames":45},"EXV-802","EXPERIMENTAL","Participants will be assigned to treatment with EXV-802 capsules administered twice a day over a 6-week period.",[46],"Drug: EXV-802",{"label":48,"type":49,"description":50,"interventionNames":51},"Placebo","PLACEBO_COMPARATOR","Participants will be assigned to treatment with placebo capsules administered twice a day over a 6-week period.",[52],"Drug: Placebo",{"label":54,"type":43,"description":55,"interventionNames":56},"EXV-801","Participants will be assigned to treatment with EXV-801 capsules administered twice a day over a 6-week period.",[57],"Drug: EXV-801",[59,65,67],{"type":60,"name":42,"description":61,"armGroupLabels":62,"otherNames":63},"DRUG","Specified dose twice daily",[42],[64],"Dextromethorphan + EXV-801",{"type":60,"name":48,"description":61,"armGroupLabels":66,"otherNames":30},[48],{"type":60,"name":54,"description":61,"armGroupLabels":68,"otherNames":69},[54],[70],"deramciclane",[72],{"name":73,"role":74,"phone":75,"phoneExt":30,"email":76},"Exciva Clinical Studies","CONTACT","+49 6221-6479990","studies@exciva.com",[78,92,102,112,123,133,141,151,161,171,178,181,190,199,210,220,230,240,252,262,271,281,293,299,309,319,328,338,350,360,370,376,386,396,405,415,424,434,446,456,466,476,486,498,508,517,527,536,548],{"facility":79,"status":80,"city":81,"state":82,"zip":83,"country":84,"countryCode":85,"cosmosGeoPoint":86,"geoPoint":91,"contacts":30},"Esperanza Clinical","RECRUITING","Murrieta","California","92562","United States","US",{"type":87,"coordinates":88},"Point",[89,90],-117.21392,33.55391,{"lat":90,"lon":89},{"facility":93,"status":80,"city":94,"state":95,"zip":96,"country":84,"countryCode":85,"cosmosGeoPoint":97,"geoPoint":101,"contacts":30},"Josephson Wallack Munshower Neurology PC","Indianapolis","Indiana","46260",{"type":87,"coordinates":98},[99,100],-86.15804,39.76838,{"lat":100,"lon":99},{"facility":103,"status":80,"city":104,"state":105,"zip":106,"country":84,"countryCode":85,"cosmosGeoPoint":107,"geoPoint":111,"contacts":30},"Precise Research Centers","Flowood","Mississippi","39232",{"type":87,"coordinates":108},[109,110],-90.13898,32.30959,{"lat":110,"lon":109},{"facility":113,"status":114,"city":115,"state":116,"zip":117,"country":84,"countryCode":85,"cosmosGeoPoint":118,"geoPoint":122,"contacts":30},"Galen Research LLC","NOT_YET_RECRUITING","Chesterfield","Missouri","63005",{"type":87,"coordinates":119},[120,121],-90.57707,38.66311,{"lat":121,"lon":120},{"facility":124,"status":80,"city":125,"state":126,"zip":127,"country":84,"countryCode":85,"cosmosGeoPoint":128,"geoPoint":132,"contacts":30},"Integrative Clinical Trials","Brooklyn","New York","11229",{"type":87,"coordinates":129},[130,131],-73.94958,40.6501,{"lat":131,"lon":130},{"facility":134,"status":80,"city":126,"state":126,"zip":135,"country":84,"countryCode":85,"cosmosGeoPoint":136,"geoPoint":140,"contacts":30},"Manhattan Behavioral Medicine","10036",{"type":87,"coordinates":137},[138,139],-74.00597,40.71427,{"lat":139,"lon":138},{"facility":142,"status":80,"city":143,"state":144,"zip":145,"country":84,"countryCode":85,"cosmosGeoPoint":146,"geoPoint":150,"contacts":30},"Insight Clinical Trials","Independence","Ohio","44131",{"type":87,"coordinates":147},[148,149],-81.6379,41.36866,{"lat":149,"lon":148},{"facility":152,"status":114,"city":153,"state":154,"zip":155,"country":84,"countryCode":85,"cosmosGeoPoint":156,"geoPoint":160,"contacts":30},"Oregon Health & Science University","Portland","Oregon","97239",{"type":87,"coordinates":157},[158,159],-122.67621,45.52345,{"lat":159,"lon":158},{"facility":162,"status":80,"city":163,"state":164,"zip":165,"country":84,"countryCode":85,"cosmosGeoPoint":166,"geoPoint":170,"contacts":30},"The Memory Clinic","Bennington","Vermont","05201",{"type":87,"coordinates":167},[168,169],-73.19677,42.87813,{"lat":169,"lon":168},{"facility":172,"status":114,"city":173,"state":174,"zip":175,"country":176,"countryCode":177,"cosmosGeoPoint":30,"geoPoint":30,"contacts":30},"Sunnybrook Health Sciences Centre","North York","Ontario","M4N 3M5","Canada","CA",{"facility":179,"status":114,"city":173,"state":174,"zip":180,"country":176,"countryCode":177,"cosmosGeoPoint":30,"geoPoint":30,"contacts":30},"Baycrest Centre for Geriatric Care","M6A 2E1",{"facility":182,"status":80,"city":183,"state":174,"zip":184,"country":176,"countryCode":177,"cosmosGeoPoint":185,"geoPoint":189,"contacts":30},"Kawartha Centre","Peterborough","K9H 294",{"type":87,"coordinates":186},[187,188],-78.31623,44.30012,{"lat":188,"lon":187},{"facility":191,"status":114,"city":192,"state":174,"zip":193,"country":176,"countryCode":177,"cosmosGeoPoint":194,"geoPoint":198,"contacts":30},"Ontario Shores Centre for Mental Health Sciences","Whitby","L1N 5S9",{"type":87,"coordinates":195},[196,197],-78.93287,43.88342,{"lat":197,"lon":196},{"facility":200,"status":114,"city":201,"state":202,"zip":203,"country":204,"countryCode":30,"cosmosGeoPoint":205,"geoPoint":209,"contacts":30},"Brain-Soultherapy s.r.o.","Kladno","Central Bohemia","272 01","Czechia",{"type":87,"coordinates":206},[207,208],14.10285,50.14734,{"lat":208,"lon":207},{"facility":211,"status":114,"city":212,"state":213,"zip":214,"country":204,"countryCode":30,"cosmosGeoPoint":215,"geoPoint":219,"contacts":30},"NeuropsychiatrieHK, sro","Hradec Králové","Hradec Králové Region","500 02",{"type":87,"coordinates":216},[217,218],15.83277,50.20923,{"lat":218,"lon":217},{"facility":221,"status":114,"city":222,"state":223,"zip":224,"country":204,"countryCode":30,"cosmosGeoPoint":225,"geoPoint":229,"contacts":30},"Psychiatrie-Ambulance s.r.o","Pilsen","Plzeň Region","301 00",{"type":87,"coordinates":226},[227,228],13.37759,49.74747,{"lat":228,"lon":227},{"facility":231,"status":114,"city":232,"state":233,"zip":234,"country":204,"countryCode":30,"cosmosGeoPoint":235,"geoPoint":239,"contacts":30},"FNUSA - St. Anne's University Hospital Brno","Brno","South Moravian","602 00",{"type":87,"coordinates":236},[237,238],16.60796,49.19522,{"lat":238,"lon":237},{"facility":241,"status":80,"city":242,"state":243,"zip":244,"country":245,"countryCode":246,"cosmosGeoPoint":247,"geoPoint":251,"contacts":30},"Medicum Gesundheitszentrum Flugfeld - Praxis Bischof & Secheres","Böblingen","Baden-Wurttemberg","71034","Germany","DE",{"type":87,"coordinates":248},[249,250],9.01171,48.68212,{"lat":250,"lon":249},{"facility":253,"status":114,"city":254,"state":255,"zip":256,"country":245,"countryCode":246,"cosmosGeoPoint":257,"geoPoint":261,"contacts":30},"Curiositas ad sanum Studien und Beratungs GmbH","Ebersberg","Bavaria","85560",{"type":87,"coordinates":258},[259,260],11.97063,48.0771,{"lat":260,"lon":259},{"facility":263,"status":114,"city":264,"state":255,"zip":265,"country":245,"countryCode":246,"cosmosGeoPoint":266,"geoPoint":270,"contacts":30},"TUM Klinikum rechts der Isar","München","81675",{"type":87,"coordinates":267},[268,269],13.46314,48.69668,{"lat":269,"lon":268},{"facility":272,"status":114,"city":273,"state":274,"zip":275,"country":245,"countryCode":246,"cosmosGeoPoint":276,"geoPoint":280,"contacts":30},"Praxis Dr. med. Kirsten Hahn","Berlin","State of Berlin","13187",{"type":87,"coordinates":277},[278,279],13.41053,52.52437,{"lat":279,"lon":278},{"facility":282,"status":114,"city":283,"state":284,"zip":285,"country":286,"countryCode":287,"cosmosGeoPoint":288,"geoPoint":292,"contacts":30},"Azienda Ospedaliera Universitaria Policlinico Tor Vergata","Rome","Lazio","00133","Italy","IT",{"type":87,"coordinates":289},[290,291],12.51133,41.89193,{"lat":291,"lon":290},{"facility":294,"status":114,"city":283,"state":284,"zip":295,"country":286,"countryCode":287,"cosmosGeoPoint":296,"geoPoint":298,"contacts":30},"Universita degli Studi di Roma ''La Sapienza\" - Azienda Ospedaliera Sant'Andrea","00189",{"type":87,"coordinates":297},[290,291],{"lat":291,"lon":290},{"facility":300,"status":114,"city":301,"state":302,"zip":303,"country":286,"countryCode":287,"cosmosGeoPoint":304,"geoPoint":308,"contacts":30},"Azienda Ospedaliera Cardinale Giovanni Panico","Tricase","Lecce","73039",{"type":87,"coordinates":305},[306,307],18.35421,39.93018,{"lat":307,"lon":306},{"facility":310,"status":114,"city":311,"state":312,"zip":313,"country":286,"countryCode":287,"cosmosGeoPoint":314,"geoPoint":318,"contacts":30},"IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli","Brescia","Lombardy","25125",{"type":87,"coordinates":315},[316,317],10.21472,45.53558,{"lat":317,"lon":316},{"facility":320,"status":114,"city":321,"state":312,"zip":322,"country":286,"countryCode":287,"cosmosGeoPoint":323,"geoPoint":327,"contacts":30},"Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico - Main Campus","Milan","20122",{"type":87,"coordinates":324},[325,326],9.18951,45.46427,{"lat":326,"lon":325},{"facility":329,"status":114,"city":330,"state":331,"zip":332,"country":286,"countryCode":287,"cosmosGeoPoint":333,"geoPoint":337,"contacts":30},"Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone","Palermo","Sicily","90127",{"type":87,"coordinates":334},[335,336],13.3636,38.1166,{"lat":336,"lon":335},{"facility":339,"status":114,"city":340,"state":341,"zip":342,"country":343,"countryCode":344,"cosmosGeoPoint":345,"geoPoint":349,"contacts":30},"Centrum Medyczne HCP Sp. z o.o.","Poznan","Greater Poland Voivodeship","61-485","Poland","PL",{"type":87,"coordinates":346},[347,348],16.92993,52.40692,{"lat":348,"lon":347},{"facility":351,"status":114,"city":352,"state":353,"zip":354,"country":343,"countryCode":344,"cosmosGeoPoint":355,"geoPoint":359,"contacts":30},"Krakowska Akademia Neurologii","Krakow","Lesser Poland Voivodeship","31-505",{"type":87,"coordinates":356},[357,358],19.93658,50.06143,{"lat":358,"lon":357},{"facility":361,"status":114,"city":362,"state":363,"zip":364,"country":343,"countryCode":344,"cosmosGeoPoint":365,"geoPoint":369,"contacts":30},"NZOZ Wroclawskie Centrum Alzheimerowskie","Wroclaw","Lower Silesian Voivodeship","53-659",{"type":87,"coordinates":366},[367,368],17.03006,51.10286,{"lat":368,"lon":367},{"facility":371,"status":114,"city":362,"state":363,"zip":372,"country":343,"countryCode":344,"cosmosGeoPoint":373,"geoPoint":375,"contacts":30},"FutureMeds Wroclaw","53-673",{"type":87,"coordinates":374},[367,368],{"lat":368,"lon":367},{"facility":377,"status":114,"city":378,"state":379,"zip":380,"country":343,"countryCode":344,"cosmosGeoPoint":381,"geoPoint":385,"contacts":30},"NZOZ Neuromed M. i M. Nastaj Spolka Partnerska","Lublin","Lublin Voivodeship","20-064",{"type":87,"coordinates":382},[383,384],22.57009,51.25058,{"lat":384,"lon":383},{"facility":387,"status":114,"city":388,"state":389,"zip":390,"country":343,"countryCode":344,"cosmosGeoPoint":391,"geoPoint":395,"contacts":30},"RCMed Oddzial Sochaczew","Sochaczew","Masovian Voivodeship","69-500",{"type":87,"coordinates":392},[393,394],20.23838,52.22944,{"lat":394,"lon":393},{"facility":397,"status":114,"city":398,"state":389,"zip":399,"country":343,"countryCode":344,"cosmosGeoPoint":400,"geoPoint":404,"contacts":30},"ETG Neuroscience Sp. z o.o.","Warsaw","02-677",{"type":87,"coordinates":401},[402,403],21.01178,52.22977,{"lat":403,"lon":402},{"facility":406,"status":80,"city":407,"state":408,"zip":409,"country":343,"countryCode":344,"cosmosGeoPoint":410,"geoPoint":414,"contacts":30},"Silmedic Sp. z o.o.","Katowice","Silesian Voivodeship","40-282",{"type":87,"coordinates":411},[412,413],19.02173,50.2597,{"lat":413,"lon":412},{"facility":416,"status":114,"city":417,"state":408,"zip":418,"country":343,"countryCode":344,"cosmosGeoPoint":419,"geoPoint":423,"contacts":30},"Clinhouse Sp. z o.o.","Zabrze","41-807",{"type":87,"coordinates":420},[421,422],18.78576,50.32492,{"lat":422,"lon":421},{"facility":425,"status":80,"city":426,"state":427,"zip":428,"country":343,"countryCode":344,"cosmosGeoPoint":429,"geoPoint":433,"contacts":30},"Velocity Clinical Research, Staszów","Staszów","Świętokrzyskie Voivodeship","28-200",{"type":87,"coordinates":430},[431,432],21.16593,50.56307,{"lat":432,"lon":431},{"facility":435,"status":114,"city":436,"state":437,"zip":438,"country":439,"countryCode":440,"cosmosGeoPoint":441,"geoPoint":445,"contacts":30},"MUDr. Beata Dupejova, Neurologicka Ambulancia S.r.o.","Banská Bystrica","Banská Bystrica Region","974 04","Slovakia","SK",{"type":87,"coordinates":442},[443,444],19.14932,48.73947,{"lat":444,"lon":443},{"facility":447,"status":114,"city":448,"state":449,"zip":450,"country":439,"countryCode":440,"cosmosGeoPoint":451,"geoPoint":455,"contacts":30},"Univerzitna nemocnica Bratislava","Bratislava","Bratislava Kraj","813 69",{"type":87,"coordinates":452},[453,454],17.10674,48.14816,{"lat":454,"lon":453},{"facility":457,"status":114,"city":458,"state":459,"zip":460,"country":439,"countryCode":440,"cosmosGeoPoint":461,"geoPoint":465,"contacts":30},"EPAMED s r.o.","Košice","Košice Region","040 11",{"type":87,"coordinates":462},[463,464],21.25802,48.71441,{"lat":464,"lon":463},{"facility":467,"status":114,"city":468,"state":469,"zip":470,"country":439,"countryCode":440,"cosmosGeoPoint":471,"geoPoint":475,"contacts":30},"Crystal Comfort S.R.O.","Vranov nad Topľou","Presov","093 01",{"type":87,"coordinates":472},[473,474],21.68479,48.88836,{"lat":474,"lon":473},{"facility":477,"status":114,"city":478,"state":479,"zip":480,"country":439,"countryCode":440,"cosmosGeoPoint":481,"geoPoint":485,"contacts":30},"Medicinske Centrum Konzilium, s.r.o.","Dubnica nad Váhom","Trenčín Region","018 41",{"type":87,"coordinates":482},[483,484],18.16634,48.95981,{"lat":484,"lon":483},{"facility":487,"status":114,"city":488,"state":489,"zip":490,"country":491,"countryCode":492,"cosmosGeoPoint":493,"geoPoint":497,"contacts":30},"Hospital Victoria Eugenia Cruz Roja Sevilla","Seville","Andalusia","41009","Spain","ES",{"type":87,"coordinates":494},[495,496],-5.97317,37.38283,{"lat":496,"lon":495},{"facility":499,"status":114,"city":500,"state":501,"zip":502,"country":491,"countryCode":492,"cosmosGeoPoint":503,"geoPoint":507,"contacts":30},"Hospital Universitario Rio Hortega","Valladolid","Castille and León","47012",{"type":87,"coordinates":504},[505,506],-4.72353,41.65541,{"lat":506,"lon":505},{"facility":509,"status":114,"city":510,"state":501,"zip":511,"country":491,"countryCode":492,"cosmosGeoPoint":512,"geoPoint":516,"contacts":30},"Hospital Virgen de la Concha","Zamora","49029",{"type":87,"coordinates":513},[514,515],-5.74456,41.50633,{"lat":515,"lon":514},{"facility":518,"status":114,"city":519,"state":520,"zip":521,"country":491,"countryCode":492,"cosmosGeoPoint":522,"geoPoint":526,"contacts":30},"Hospital Universitari Germans Trias i Pujol","Barcelona","Catalonia","08916",{"type":87,"coordinates":523},[524,525],2.15899,41.38879,{"lat":525,"lon":524},{"facility":528,"status":80,"city":529,"state":30,"zip":530,"country":491,"countryCode":492,"cosmosGeoPoint":531,"geoPoint":535,"contacts":30},"Hospital Clinico San Carlos","Madrid","28040",{"type":87,"coordinates":532},[533,534],-3.70256,40.4165,{"lat":534,"lon":533},{"facility":537,"status":80,"city":538,"state":539,"zip":540,"country":541,"countryCode":542,"cosmosGeoPoint":543,"geoPoint":547,"contacts":30},"Scottish Brain Sciences","Edinburgh","Midlothian","EH12 5PJ","United Kingdom","UK",{"type":87,"coordinates":544},[545,546],-3.19648,55.95206,{"lat":546,"lon":545},{"facility":537,"status":80,"city":549,"state":550,"zip":551,"country":541,"countryCode":542,"cosmosGeoPoint":552,"geoPoint":556,"contacts":30},"Aberdeen","North East Scotland","AB25 2XE",{"type":87,"coordinates":553},[554,555],-2.09814,57.14369,{"lat":555,"lon":554},{"type":558,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100614813",false,"NCT07284472","Safety and Efficacy of EXV-802 and EXV-801 in the Treatment of Agitation in Alzheimer's Disease Dementia","Phase 2\u002F3, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of EXV-802 and EXV-801 in the Treatment of Agitation in Participants With Alzheimer's Disease Dementia","SERENADA","Inclusion criteria:\n\n1. The participant is an adult male or female between the ages of 55 to 90 years inclusively, who can move around by themselves, with a walker or a wheelchair.\n2. A previously established diagnosis of AD dementia.\n3. The participant has clinically significant, moderate\u002Fsevere agitation at the time of screening and for at least 2 weeks prior to randomization\n4. The diagnosis of agitation must meet the International Psychogeriatric Association (IPA) provisional definition of agitation.\n5. Caregiver who is able and willing to comply with all required study procedures and who is in contact with the participant at least on four individual days for at least two hours per day.\n\nExclusion criteria:\n\n1. The participant has a confirmed primary diagnosis of a dementia-related disease other than AD dementia.\n2. The participant has symptoms of agitation that are not secondary to AD dementia\n3. The participant has a history of uncontrolled seizures or a history of epilepsy.\n4. The participant has a major medical illness or unstable medical condition","ALL","55 Years","90 Years",{"count":570,"type":571},300,"ESTIMATED","INTERVENTIONAL",[574,575],"PHASE2","PHASE3","The goal of this clinical trial is to evaluate the safety and efficacy of EXV-802 and EXV-801 in treatment of agitation in participants with Alzheimer's Disease dementia.",[578],"Agitation Associated With Alzheimer's Disease Dementia","2026-06-04",{"date":581,"type":582},"2026-06-05","ACTUAL",{"date":584,"type":582},"2026-02-02",{"date":586,"type":571},"2029-02",{"name":5,"class":6},49]