Long-term study of KarXT and KarX-EC for agitation in Alzheimer's disease
Tests KarXT and KarX-EC over time in people with Alzheimer's-related agitation.
Plain-language title generated from the registry record
Registry title: A Study to Evaluate the Long-term Efficacy and Safety of KarXT + KarX-EC for Agitation in Alzheimer's Disease (ADAGIO-3)
Key facts
- Where
- Bunkyo-ku, Fukuoka, Hadano, Kanzaki-Gun Yoshinogari-Cho, Karatsu-shi, Kawasaki, Okayama, Sakai, and Shimotsuke-shi, Tochigi, JapanSee the 9 sites
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 55 and 90 years old?
- Has a doctor told you that you have Alzheimer's disease?
- Do you have agitation caused by Alzheimer's disease, such as being restless or aggressive?
- Have you taken part in an earlier study of the same medicine (KarXT or ML-007C-MA) and finished it?
- Do you have a caregiver or trial partner who sees you regularly and can help with the study?
Source: NCT06937229, who can take part
Where in Japan
- Nippon Medical School HospitalBunkyo-ku, JapanTaking people
- Kuramitsu HospitalFukuoka, JapanTaking people
- Hatano Kousei HospitalHadano, JapanTaking people
- National Hospital Organization Hizen Psychiatric CenterKanzaki-Gun Yoshinogari-Cho, JapanTaking people
- Rainbow and Sea HospitalKaratsu-shi, JapanTaking people
- KawasakiKawasaki, JapanNot yet recruiting
- Okayama City General Medical Center Okayama City HospitalOkayama, JapanTaking people
- Asakayama HospitalSakai, JapanTaking people
- Jichi Medical University HospitalShimotsuke-shi, Tochigi, JapanTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Bristol-Myers Squibb
- Trial code
- NCT06937229EU 2024-519994-20-00
- Record updated
- 16 October 2026
- Original description
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.Read full original descriptionShow less
A Phase 3, Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-3)
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.
Inclusion: Participants must have completed study CN012-0023 or CN012-0024 per protocol; Participants must have an identified caregiver who has sufficient contact (approximately 8 hours over a week).
Exclusion: Participants must not have clinically significant cardiovascular (eg, untreated or unstable hypertension, clinically significant tachycardia), pulmonary, renal, hematologic, GI, endocrine, immunologic, dermatologic, neurologic, or oncologic disease or any other condition that, in the opinion of the investigator, would jeopardize the safety of the participant or the validity of the study results; Other protocol-defined Inclusion/Exclusion criteria apply.