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A Study to Evaluate the Long-term Efficacy and Safety of KarXT + KarX-EC for Agitation in Alzheimer's Disease (ADAGIO-3)

StatusRecruiting
PhasePhase 3
Started2025-12-02
View on ClinicalTrials.gov ↗

Amendment history

2026-08-18
Study Status, Contacts/Locations v23
Trial sites reduced: 256 → 252 locations
2026-07-27
Study Status, Contacts/Locations v22
Study sites256→258
2026-06-30
Study Status, Study Design, Eligibility, Contacts/Locations v21
Enrollment target600→650
Study sites255→256
Eligibility criteria-13 characters
[...] 012-0023 or CN012-0024 per protocol. Participants must have onean identified caregiver who should havehas sufficient contact (approximately 108 hours over a week or more). Exclusion Criteria: Participants must not have clinically [...]
2026-06-15
Study Status, Contacts/Locations v20
Study sites255 entries, revised
Local Institution - 16021664 Local Institution - 16472458 LocalHospital InstitutionClinico -San 1505Carlos LocalHospital InstitutionClinico -Universitario 1502Virgen de La Victoria LocalHospital InstitutionUniversitario -De 1506Rio Hortega
2026-06-01
Study Status, Contacts/Locations v19
Study sites253→255
2026-05-20
Study Status, Contacts/Locations v18
Trial sites expanded: 243 → 253 locations
2026-05-08
Study Status, Contacts/Locations v17
Study sites241→243
2026-04-20
Study Status, Contacts/Locations v16
Study sites240→241
2026-04-03
Study Status, Contacts/Locations v15
Study sites241→240
2026-03-13
Study Status, Contacts/Locations v14
Study sites241 entries, revised
LocalBoston InstitutionCenter -for 1638Memory LocalOkayama InstitutionCity -General 1306Medical Center Okayama City Hospital LocalSeoul InstitutionNational -University 2407Hospital LocalGangnam InstitutionSeverance -Hospital, 2408Yonsei University Health System LocalThe InstitutionCatholic -University 2404of Korea, Yeouido St.Mary's Hospital LocalSurrey Institutionand -Borders 2508Partnership NHS Foundation Trust
2026-02-24
Study Status, Contacts/Locations v13
Study sites244→241
2026-02-04
Study Status, Contacts/Locations, IPDSharing v12
Study sites241→244
2026-01-07
Not Yet Recruiting→Recruiting Study Status, Outcome Measures, Contacts/Locations v11
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2025-12-01→confirmed 2025-12-02
Study sites229→241
Secondary endpoints18 to 17 entries
Number of Participants With TEAEs
2025-11-18
Study Status, Contacts/Locations v10
Start date2025-11-21→2025-12-01
Study sites207→229
2025-10-16
Study Status, Contacts/Locations v9
Study sites206→207
2025-09-25
Study Status, Contacts/Locations v8
Study sites202→206
2025-08-19
Study Status, Contacts/Locations v7
Study sites180→202
2025-07-23
Study Status, Contacts/Locations v6
Study sites174→180
2025-06-24
Study Status, Contacts/Locations v5
Study sites163→174
2025-06-09
Study Status, Contacts/Locations v4
Study sites152→163
2025-05-27
Study Status, Contacts/Locations v3
Study sites143→152
2025-05-16
Study Status, Contacts/Locations v2
Primary completion date2028-11-18→2029-06-22
Completion date2028-11-18→2029-07-20
Study sites100→143
2025-05-05
Study Status, Contacts/Locations, References v1
Start date2025-11-24→2025-11-21
Study sites2→100
2025-04-15
Original filing
The purpose of this study is to evaluate the long-term efficacy and safety of combined formulation of xanomeline tartrate/trospium chloride in an immediate release (IR) capsule (KarXT) and xanomeline enteric capsules (KarX-EC) in participants with agitation associated with Alzheimer's Disease who completed the parent studies CN012-0023 or CN012-0024.
Trial Details
NCT Number NCT06937229
Lead Sponsor Bristol-Myers Squibb
Conditions Alzheimer Disease, Agitation
Enrollment 650 participants
Start Date 2025-12-02
Primary Completion 2029-06-22 (estimated)
Study Completion 2029-07-20 (estimated)
Updated on ClinicalTrials.gov 2026-09-28