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)

StatusRecruiting

PhasePhase 3

SponsorBristol-Myers Squibb

Started2025-07-10

View on ClinicalTrials.gov ↗

Amendment history

2026-09-17

Trial sites expanded: 159 → 162 locations

2026-08-10

Study Status, Contacts/Locations v39

Study sites158→159

2026-07-10

Study Status, Contacts/Locations v38

Study sites158 entries, revised

~~Local Institution~~L2IP - ~~1051~~Instituto de Pesquisas Clínicas ~~Local~~The ~~Institution~~First -Affiliated ~~1804~~Hospital of Zhejiang University

2026-06-26

Study Status, Study Design, Outcome Measures, Eligibility, Contacts/Locations v37

Enrollment increased: 352 → 426 participants

Study sites157→158

Eligibility criteria-335 characters

[...] nostic assay. Mini-Mental State Examination (MMSE) score of 5≤ ~~to 22, inclusive,~~24 at Screening (Visit 1). Have ~~one~~an identified caregiver who ~~should have~~has 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). ~~CGI~~CMAI-SIPA 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-IPA at Screening (Visit 1) and Baseline (Visit 2; CMAI-IPA Physical/Verbal Aggress~~ [...] [...]

Secondary endpoints20 entries, revised

Number of participants with 12-lead electrocardiogram (ECG) abnormalities

Primary endpoints1 entry, revised

Change from baseline on the Cohen-Mansfield Agitation Inventory-International Psychogeriatric Association (CMAI-IPA) ~~total~~Total ~~score~~Score at Week 14

2026-06-09

Study Status, Contacts/Locations v36

Study sites157 entries, revised

~~Kaizen Brain Center~~ Local Institution - ~~1809~~1637 The Affiliated Brain Hospital of Guangzhou Medical University Xiangya Hospital Central South University Nanjing Drum Tower hospital Unidade Local ~~Institution~~de -Saúde ~~1803 Local~~de ~~Institution~~Coimbra, ~~- 1801 Local Institution - 1401~~E.P.E.

Show 35 earlier versions

2026-06-02

Study Status, Contacts/Locations v35

Study sites157 entries, revised

~~Local~~Hatano ~~Institution~~Kousei -Hospital Clinical ~~1301 Local~~Psychiatric ~~Institution~~Hospital -"Dr. ~~1462~~Gheorghe Preda"

2026-05-28

Study Status, Contacts/Locations v34

Study sites157 entries, revised

Local Institution - ~~1661~~1666 ~~Local~~NeuroBehavioral ~~Institution~~Medicine -Group Global ~~1665~~Medical Institutes LLC; Princeton Medical Institute ~~Local~~CEN ~~Institution~~Centro -Especializado ~~1664~~en Neurociencias ~~Local~~Nucleo ~~Institution~~de -Pesquisa ~~1004~~Clinica do Rio Grande do Sul ~~Local~~The ~~Institution~~First -Affiliated ~~1058~~Hospital of Chongqing Medical University ~~Local~~The ~~Institution~~Second -Affiliated ~~1813~~Hospital of Guangzhou Medical University ~~Local~~Mental ~~Institution~~Health -Center ~~1802~~of Xi'an City ~~Local~~Sir ~~Institution~~Run -Run ~~1816~~Shaw Hospital, School of Medicine, Zhejiang University ~~Local~~The ~~Institut~~ [...] [...]

2026-04-29

Study Status, Contacts/Locations v33

Study sites157 entries, revised

~~Local~~Shenzhen ~~Institution~~Kangning ~~- 1818~~Hospital ~~Local~~Tianjin ~~Institution~~Anding ~~- 1814~~Hospital

2026-04-21

Study Status, Contacts/Locations v32

Study sites157 entries, revised

~~Local~~Elixia ~~Institution~~MA Five Towns Neurology PC -Woodmere - ~~1660~~923 Broadway Fundacion Estudios Clinicos Centro Medico Luquez Clinica Viver - Centro de Desospitalizacao Humana Local Institution - ~~1658~~1104 ~~Local~~Centre ~~Institution~~for Addiction & Mental Health Xuanwu Hospital Capital Medical University Innovacion y Desarrollo en Ciencias de la Salud AVIX Investigacion Clinica Prof. Dr. Alexandru Obregia Psychiatry Hospital Prof Dr Alexandru Obregia Clinical Psychiatric Hospital- ~~1653 Local~~Centrul ~~Institution~~de -Sanatate ~~1006 Local Institution - 1000 Local Institution - 1056 Local Institution -~~ [...] [...]

2026-03-30

Study Status, Contacts/Locations v31

Study sites157 entries, revised

~~Nuovida Research Center~~ Local Institution - ~~1646~~1604 ~~Local~~The ~~Institution~~Memory -Clinic Clinical ~~1551~~Hospital Center Split

2026-03-23

Study Status, Contacts/Locations v30

Study sites157 entries, revised

~~Local~~PUCTrials Hospital ~~Institution~~Moinhos -de ~~1052~~Vento ~~Local~~Ruschel ~~Institution~~Medicina -e ~~1054~~Pesquisa Clínica ~~Local~~Henry ~~Institution~~Dunant -Hospital ~~1050~~Center ~~Local~~Eginition ~~Institution - 1205 Local Institution - 1202~~Hospital

2026-03-10

Study Status, Contacts/Locations v29

Study sites157 entries, revised

~~Local Institution~~CECPAR - ~~1053~~Centro de Estudos Clínicos do Paraná ~~Local~~Hospital ~~Institution~~Universitario -de ~~1355~~Saltillo ~~Local~~Neurociencias ~~Institution~~PRISMA -A.C. Prof. ~~1362 Local~~Dr. ~~Institution~~Alexandru -Obregia ~~1453~~Psychiatry Hospital

2026-03-02

Study Status, Contacts/Locations v28

Study sites157 entries, revised

~~Local~~Medical ~~Institution~~Center Sveti Naum EOOD London Health Sciences Centre-Victoria ~~1100~~Campus ~~Local~~General ~~Institution~~Hospital -Varazdin University ~~1155~~Hospital of Patras ~~Local~~Okayama ~~Institution~~City -General ~~1552 Local~~Medical ~~Institution~~Center -Okayama ~~1200 Local~~City ~~Institution - 1306~~Hospital

2026-02-20

Study Status, Contacts/Locations v27

Study sites158→157

2026-02-10

Study Status, Contacts/Locations v26

Study sites158 entries, revised

~~Local~~CPQuali ~~Institution~~Pesquisa Clínica Aiginiteio University Hospital University General Hospital "ATTIKON" - ~~1055~~General Hospital of West Attica "H AGIA VARVARA" ~~Local~~Kuramitsu ~~Institution~~Hospital Boca -Clinical ~~1206~~Trials Mexico S.C. ~~Local~~Clinical ~~Institution~~Research -Institute ~~1203 Local Institution - 1302 Local Institution - 1356 Local Institution - 1352~~S.C.

2026-01-30

Study Status, Contacts/Locations, IPDSharing v25

Study sites158 entries, revised

~~Local~~The ~~Institution~~Neurology Group Rainbow and Sea Hospital Centro Hospitalar do Alto Ave Chang Gung Medical Foundation-Linkou ~~1662 Local Institution - 1300 Local Institution - 1402 Local Institution - 1752~~Branch

2026-01-26

Study Status, Contacts/Locations v24

Study sites158 entries, revised

~~Local~~Instituto ~~Institution~~Privado Kremer Prof. Dr. Alexandru Obregia Psychiatry Hospital Oroitu Centro de Atencion Especializada Hospital Universitario de Salamanca - ~~1005 Local~~Complejo ~~Institution~~Asistencial -Universitario ~~1458 Local~~de ~~Institution - 1510 Local Institution - 1500~~Salamanca

2026-01-22

Study Status, Contacts/Locations v23

Study sites158 entries, revised

~~Local~~National ~~Institution~~Cheng -Kung ~~1751~~University Hospital ~~Local~~National ~~Institution~~Taiwan -University ~~1754~~Hospital

2026-01-20

Study Status, Contacts/Locations v22

Study sites158 entries, revised

~~Local~~Outpatient ~~Institution~~Clinic for Individual Practice for Specialized Medical Care in Psychiatry - ~~1103~~Dr. Madlena Dimitrova Borisova Sunnybrook Research Institute Unidade Local ~~Institution~~de -Saúde ~~1151 Local~~de ~~Institution~~Matosinhos ~~- 1403~~SA

2026-01-12

Study Status, Contacts/Locations v21

Study sites158 entries, revised

~~Local~~Hospital ~~Institution~~Victoria -Eugenia ~~1503~~de Sevilla

2026-01-08

Study Status, Contacts/Locations v20

Study sites158 entries, revised

~~Local~~Taipei ~~Institution~~Veterans -General ~~1750~~Hospital

2026-01-02

Study Status, Contacts/Locations v19

Study sites158 entries, revised

~~Local~~Mid ~~Institution~~Hudson -Medical ~~1656~~Research ~~Local~~Medical ~~Institution~~Center -Mladost Teikyo ~~1102~~University Mizonokuchi Hospital ~~Local~~National ~~Institution~~Hospital -Organization ~~1307~~Hizen Psychiatric Center ~~Local~~Hospital ~~Institution~~General -Universitario ~~1303~~de Elche ~~Local~~Complejo ~~Institution~~Hospitalario -Ruber ~~1509~~Juan Bravo ~~Local~~Hospital ~~Institution~~Mutua -Terrassa Hospital ~~1508~~Universitario De Rio Hortega ~~Local~~Hospital ~~Institution~~Viamed ~~- 1504 Local Institution - 1506 Local Institution - 1501~~Montecanal

2025-12-10

Study Status, Outcome Measures, Contacts/Locations v18

Study sites157→158

Secondary endpoints20 entries, reordered

2025-12-02

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 [...] [...]

Secondary endpoints20 entries, revised

~~Mean change~~Change from baseline on the Clinical Global Impressions-Severity (CGI-S) at Week 14 ~~Mean change~~Change from baseline on the CMAI-IPA Domains at Week 14 ~~Mean change~~Change from baseline on the CMAI Total Score at Week 14 ~~Mean change~~Change from baseline on the Neuropsychiatric Inventory/Neuropsychi [...]

Primary endpoints1 entry, revised

~~Mean change~~Change from baseline on the Cohen-Mansfield Agitation Inventory-In [...]

Study sites157 entries, revised

~~Local~~Wasatch ~~Institution~~Clinical -Research, ~~1641~~LLC ~~Local~~Ontario ~~Institution~~Shores -Centre ~~1152~~For Mental Health Sciences ~~Local~~Campus ~~Institution~~Neurologico -Senior Prof. ~~1400~~Dr. Alexandru Obregia Psychiatry Hospital ~~Local~~Prof. ~~Institution~~Dr. -Alexandru ~~1455~~Obregia Psychiatry Hospital ~~Local~~Hospital ~~Institution~~Clinico -Universitario ~~1456 Local~~Virgen ~~Institution~~de -La ~~1502~~Victoria

2025-11-18

Study Status, Contacts/Locations v16

Study sites153→157

2025-11-12

Study Status, Contacts/Locations v15

Study sites153 entries, revised

~~Local~~Advanced ~~Institution~~Research Center (ARC) - ~~1657~~Anaheim

2025-11-04

Study Status, Contacts/Locations v14

Study sites152→153

2025-10-31

Study Status, Contacts/Locations v13

Study sites140→152

2025-10-03

Study Status, Eligibility, Contacts/Locations v12

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 sites140 entries, revised

~~Local~~Mayflower ~~Institution~~Clinical ~~- 1642~~Research

2025-09-30

Study Status, Contacts/Locations v11

Study sites139→140

2025-09-25

Study Status, Contacts/Locations v10

Study sites134→139

2025-09-02

Study Status, Contacts/Locations v9

Study sites126→134

2025-08-25

Study Status, Contacts/Locations v8

Study sites126 entries, revised

~~Local~~Combined ~~Institution~~Research -Orlando ~~1635~~(CRO) ~~Local~~Progressive ~~Institution~~Medical -Research Boston ~~1612 Local~~Center ~~Institution~~for ~~- 1638~~Memory

2025-08-14

Study Status, Contacts/Locations v7

Start dateestimated 2025-07-18→confirmed 2025-07-10

Study sites126 entries, revised

~~Local~~Nuovida ~~Institution~~Research ~~- 1604~~Center

2025-07-24

Study Status, Contacts/Locations v6

Study sites125→126

2025-07-22

Study Status, Contacts/Locations v5

Study sites125 entries, revised

~~Local~~Imaging ~~Institution - 1619~~Endpoints

2025-07-15

Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v4

Trial statusNot Yet Recruiting→Recruiting

Study sites206→125

2025-07-07

Study Status, Contacts/Locations, References v3

Study sites205→206

2025-06-17

Study Status, Contacts/Locations v2

Study sites204→205

2025-06-10

Study Status, Contacts/Locations v1

Study sites203→204

2025-06-02

Original filing

Bristol-Myers Squibb

311 trials monitored

See 15 trials at risk

Alzheimer's Disease

1,140 trials monitored

See 62 trials at risk

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	NCT07011732
Lead Sponsor	Bristol-Myers Squibb
Conditions	Alzheimer Disease
Enrollment	426 participants
Start Date	2025-07-10
Primary Completion	2028-11-24 (estimated)
Study Completion	2028-12-08 (estimated)
Updated on ClinicalTrials.gov	2026-09-16