A Study to Evaluate the Long-term Efficacy and Safety of KarXT + KarX-EC for Agitation in Alzheimer's Disease (ADAGIO-3)
Recruiting now · Phase 3
Conditions studied: Alzheimer Disease, Agitation
In brief
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.
Key facts
- Study ID
- NCT06937229
- Run by
- Bristol-Myers Squibb
- People needed
- 650
- Starts
- 2025-12-02
- Expected to finish
- 2029-07-20
- Last updated by the study team
- 2026-07-28
Who can join
Age: 55 and older, up to 90. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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).
You may not qualify if…
- 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.
Where it is running
- Asakayama Hospital — Sakai, Osaka, Japan (enrolling)
- Gangnam Severance Hospital, Yonsei University Health System — Seoul, South Korea (enrolling)
- Pantheon Clinical Research, LLC — Bountiful, Utah, United States (enrolling)
- Hatano Kousei Hospital — Hadano, Kanagawa, Japan (enrolling)
- Kuramitsu Hospital — Fukuoka, Japan (enrolling)
- Seoul National University Hospital — Seoul, Seoul-teukbyeolsi [Seoul], South Korea (enrolling)
- Redbird Research — Las Vegas, Nevada, United States (enrolling)
- Epic Medical Research, LLC - Carrolton — Carrollton, Texas, United States (enrolling)
- Hospital Moinhos de Vento — Porto Alegre, Rio Grande do Sul, Brazil (enrolling)
- Auxologico IRCCS - Auxologico San Luca — Milan, Lombardy, Italy (enrolling)
- Rainbow and Sea Hospital — Karatsu-shi, Saga-ken, Japan (enrolling)
- Nippon Medical School Hospital — Bunkyo-ku, Tokyo, Japan (enrolling)
- Okayama City General Medical Center Okayama City Hospital — Okayama, Japan (enrolling)
- Neurociencias PRISMA A.C. — San Luis Potosí City, Mexico (enrolling)
- Imaging Endpoints — Scottsdale, Arizona, United States (enrolling)
- Nuovida Research Center — Miami, Florida, United States (enrolling)
- West Clinical Research — Morehead City, North Carolina, United States (enrolling)
- Progressive Medical Research — Port Orange, Florida, United States (enrolling)
- IPTB Clinical Research — Tampa, Florida, United States (enrolling)
- Hope Research Network - Miami — Virginia Gardens, Florida, United States (enrolling)
- CPQuali Pesquisa Clínica — São Paulo, Brazil (enrolling)
- Bayit Balev Ltd. — Rishon Le'Tzion, Israel (enrolling)
- Boston Center for Memory — Newton, Massachusetts, United States (enrolling)
- National Hospital Organization Hizen Psychiatric Center — Kanzaki-Gun Yoshinogari-Cho, Saga-ken, Japan (enrolling)
- The Catholic University of Korea, Yeouido St.Mary's Hospital — Seoul, South Korea (enrolling)
Full record on ClinicalTrials.gov
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