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A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease

StatusRecruiting
PhasePhase 3
Started2025-07-16
View on ClinicalTrials.gov ↗

Amendment history

2026-08-25
Study Status, Contacts/Locations v36
Study sites145→144
2026-07-28
Study Identification, Study Status, Conditions, Study Design, Outcome Measures, Eligibility, Contacts/Locations, IPDSharing v35
Enrollment increased: 352 → 426 participants
Eligibility criteria-263 characters
[...] nostic assay. Mini-Mental State Examination (MMSE) score of 5≤ to 22, inclusive,24 at Screening (Visit 1). Have onean identified caregiver who should havehas sufficient contact (approximately 108 hours over a week or more) and is willing to: i) Attend all visits and report on part [...] on score ≥ 4 at Screening (Visit 1) and Baseline (Visit 2). CGICohen-SMansfield Agitation Inventory-International Psychogeriatric Association (CMAI-IPA) Total Score ≥ 4, as related to agitation,30 at Screening (Visit 1) and Baseline (Visit 2). At least 1 of the following 3 criteria must be established from the CMAI-IP [...] [...]
Secondary endpointsdetails revised at 6 of 20 entries
Study sites145 entries, revised
LocalBiomedica InstitutionResearch Group Pontificia Universidad Catolica de Chile Clinica Alemana Psicomed Estudios Médicos Cía Ltda Debreceni Egyetem Klinikai Kozpont CMRC Headlands Communal non-commercial 2051 Local Institution - 2052 Local Institution - 2054 Local Institution - 2053 Local Institution - 2252 Local Institution - 2645 CNCEenterprise "Cherkasy regional psychiatric hospital of Cherkasy regional council" LocalLimited InstitutionLiability -Company 2569"Iqmed"
Study title-11 characters
[...] e Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-2)
2026-06-24
Study Status, Contacts/Locations v34
Trial sites expanded: 141 → 145 locations
2026-06-09
Study Status, Contacts/Locations v33
Study sites140→141
2026-06-02
Study Status, Contacts/Locations v32
Study sites140 entries, revised
Alliance Clinical -West Hills Local Institution - 20002620 LocalInstituto InstitutionModelo -de 2253Neurología, Fundación Lennox LocalSemmelweis InstitutionEgyetem Instituto -De 2640Neurologia Dra. Ivonne Fraga
Show 31 earlier versions
2026-05-26
Study Status, Contacts/Locations v31
Study sites140 entries, revised
Local Institution - 26382646 LocalEvergreenHealth InstitutionMedical Center Centro Neurobiológico y de Estrés Traumático - 2005CENydET S.R.L. LocalInstituto InstitutionMédico -DAMIC Resolution 2003Psychopharmacology Research Institute LocalCNCE Institution"Clinical -Facility 2001for Mental Health Care "PSYCHIATRY" of executive body of Kyiv City Council (KCSA)" LocalCNCE Institution"Clinical -Facility 2301 Localfor InstitutionMental -Health 2556 LocalCare Institution"PSYCHIATRY" -of 2553executive body of Kyiv City Council (KCSA)
2026-04-29
Study Status, Contacts/Locations v30
Study sites140 entries, revised
SharlinLocal HealthInstitution Neuroscience- Research Center Pantheon Clinical Research, LLC2603 Local Institution - 25662612 CNCE of the Kyiv Regional Council "Regional Psychiatric-Narcological Medical Association"
2026-04-21
Study Status, Contacts/Locations v29
Study sites140 entries, revised
LocalNational InstitutionInstitute of Clinical Research Fundacion para el Estudio y Tratamiento de Enfermedades mentales- FETEM Hopital Gui Chauliac - 2625Chu Montpellier MNCC Dnipropetrovsk Multiprofile Clinical Hospital for Provision of Psychiatric Care DRC CNCE of Lviv Regional Council "Lviv Regional Clinical Psychiatric Hospital" CNCE "Odesa Regional Mental Health Medical Center" of the ORC" Local Institution - 26432562 LocalCommunal Non-Commercial Enterprise "Regional Clinical Psychiatric Hospital of the Kirovohrad RC Communal Enterprise "Regional Institution of Mental Psychiatric Care of [...] [...]
2026-03-30
Study Status, Contacts/Locations v28
Study sites140 entries, revised
LocalCNCE Institution"Cherkasy regional psychiatric hospital of Cherkasy regional council" CNPE "Vinnytsia Regional Clinical Psycho-Neurological 2555Hospital n.a. Acad. O.I. Yushchenko of Vinnytsia Regional Counsil" Local"Medical InstitutionCentre -"Neuroclinic" 2558 Local Institution - 2551LLC
2026-03-02
Study Status, Contacts/Locations v27
Study sites141→140
2026-02-20
Study Status, Contacts/Locations v26
Study sites139→141
2026-02-10
Study Status, Contacts/Locations v25
Study sites140→139
2026-01-30
Study Status, Contacts/Locations, IPDSharing v24
Study sites140 entries, revised
LocalAGE InstitutionCentrum Centre Hospitalier Régional Universitaire de Lille - 2107 LocalHôpital InstitutionRoger - 2153Salengro
2026-01-26
Study Status, Contacts/Locations v23
Study sites139→140
2026-01-22
Study Status, Contacts/Locations v22
Study sites139 entries, revised
LocalAzienda InstitutionOspedaliero-Universitaria Policlinico Umberto I - 2354Viale del Policlinico 155 LocalAuxologico InstitutionIRCCS - 2353Auxologico San Luca LocalAzienda InstitutionOspedaliero -Universitaria 2350Pisana
2026-01-20
Study Status, Contacts/Locations v21
Study sites139 entries, revised
LocalNeuropsychiatrie Institut Institutionneuropsychiatricke pece (INEP), Praha NEUROHK The Chaim Sheba Medical Center University of Naples Federico II Azienda Ospedaliero-Universitaria 2100Sant'Andrea LocalAzienda InstitutionOspedaliera -Spedali 2106Civili di Brescia LocalCentrum InstitutionMedyczne -HCP 2101Szpital im. Jana Pawla II LocalCentrum InstitutionIn -Psyche 2305Spersonalizowanej Psychiatrii I Terapii LocalRCMed InstitutionOddzial -Sochaczew South 2351 LocalLondon Institutionand -Maudsley 2352 LocalNHS InstitutionFoundation - 2356 Local Institution - 2450 Local Institution - 2455 Lo [...] [...]
2026-01-12
Study Status, Contacts/Locations v20
Study sites139 entries, revised
LocalA-SHINE Institution - 2104s.r.o.
2026-01-08
Study Status, Contacts/Locations v19
Study sites139 entries, revised
LocalVestra InstitutionClinics - 2108s.r.o.
2026-01-02
Study Status, Contacts/Locations v18
Study sites139 entries, revised
LocalNeuro InstitutionHealth Centrum s.r.o. Centre Hospitalier Universitaire de Limoges - 2103Hôpital Dupuytren LocalLes InstitutionHôpitaux Universitaires de Strasbourg - 2156Hôpital de la Robertsau LocalBayit InstitutionBalev -Ltd. The 2155Israeli Alzheimer Medical Center LocalFondazione InstitutionPoliclinico -Gemelli 2304IRCCS LocalM2M Institution - 2300 Local Institution - 2357 Local Institution - 2456Med
2025-12-10
Study Identification, Study Status, Outcome Measures, Eligibility, Contacts/Locations v17
Eligibility criteria+13 characters
[...] ria with one of the following confirmations of AD pathology:. i) Historical evidence of AD diagnosis with amyloid positro [...] d diagnostic assay. ii) If no historical evidence available:. A. A plasma biomarker will be assessed for eligibility if a [...] the assay result is inconclusive, conduct one the following:. Amyloid PET. Aβ42/40 ratio or pTau181/Aβ42 ratio in CSF usi [...] t (approximately 10 hours a week or more) and is willing to:. i) Attend all visits and report on participant's status. ii [...] e (Visit 2; CMAI-IPA Physical/Verbal Aggression Positivity):. i) 1 or more aggressive behaviors occurring at least s [...] [...]
Secondary endpoints20 entries, revised
Mean changeChange from baseline on the Clinical Global Impressions-Severity (CGI-S) at Week 14 Mean changeChange from baseline on the CMAI-IPA Domains at Week 14 Mean changeChange from baseline on the CMAI Total Score at Week 14 Mean changeChange from baseline on the Neuropsychiatric Inventory/Neuropsychi [...] tory -Nursing Home (NPI/NPI-NH) Total Score at Week 14 Body Weightweight
Primary endpoints1 entry, revised
Mean changeChange from baseline on the Cohen-Mansfield Agitation Inventory-In [...]
Study sitesdetails revised at 1 of 139 sites
2025-12-02
Study Status, Contacts/Locations v16
Study sites139 entries, revised
LocalKey InstitutionClinical Research Las Vegas Clinical Trials Centre Hospitalier Universitaire Toulouse - 2624Cité de la Santé LocalSanz InstitutionMC, -Laniado 2628Hospital LocalCornwall InstitutionPartnership -NHS 2150 LocalFoundation Institution - 2303 Local Institution - 2507Trust
2025-11-24
Study Status, Contacts/Locations v15
Study sites138→139
2025-11-04
Study Status, Contacts/Locations v14
Study sites138 entries, revised
LocalChandler InstitutionClinical -Trials, 2609LLC LocalGachon InstitutionUniversity -Gil 2409Medical Center LocalGangnam InstitutionSeverance -Hospital, 2408Yonsei University Health System
2025-10-31
Study Status, Contacts/Locations v13
Study sites137→138
2025-10-07
Study Status, Contacts/Locations v12
Study sites133→137
2025-10-03
Study Status, Eligibility, Contacts/Locations v11
Eligibility criteria-2 characters
Inclusion Criteria: - A diagnosis of Alzheimer's disease (AD) in accordance wit [...] aviors occurring less than once per week. Exclusion Criteria: - Medical Conditions. i) Agitation symptoms that are primar [...]
Study sites133 entries, revised
LocalVelocity InstitutionClinical Research - 2617Blue Ash LocalInha InstitutionUniversity -Hospital Konkuk 2401University Medical Center LocalNeuroClin Institution - 2403 Local Institution - 2510Glasgow
2025-09-30
Study Status, Contacts/Locations v10
Study sites132→133
2025-09-25
Study Status, Contacts/Locations v9
Study sites127→132
2025-09-02
Study Status, Contacts/Locations v8
Study sites123→127
2025-08-25
Study Status, Contacts/Locations v7
Study sites122→123
2025-08-20
Study Status, Contacts/Locations v6
Study sites121→122
2025-08-18
Study Status, Contacts/Locations v5
Study sites119→121
2025-08-14
Study Status, Contacts/Locations v4
Start dateestimated 2025-07-18→confirmed 2025-07-16
Study sites117→119
2025-07-15
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v3
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2028-10-25→2028-11-03
Completion date2028-11-08→2028-11-13
Study sites193→117
2025-06-24
Study Status, Contacts/Locations, References v2
Study sitescontacts updated at 1 of 193 sites
2025-06-17
Study Status, Contacts/Locations v1
Study sites190→193
2025-06-02
Original filing
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.
Trial Details
NCT Number NCT07011745
Lead Sponsor Bristol-Myers Squibb
Conditions Alzheimer's Disease
Enrollment 426 participants
Start Date 2025-07-16
Primary Completion 2028-11-03 (estimated)
Study Completion 2028-11-13 (estimated)
Updated on ClinicalTrials.gov 2026-09-16