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

Bristol-Myers Squibb (BMS)

Status and phase: Begins enrollment in 5 months; Phase 3

Conditions: Alzheimer Disease; Agitation

Treatments: Drug: KarX-EC; Drug: KarXT

Study type: Interventional

Funder types: Industry

Identifiers

NCT06937229

2024-519994-20 (Other Identifier)

U1111-1316-3903 (Other Identifier)

CN012-0025

Details and patient eligibility

About

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.

Enrollment: 600 estimated patients

Sex: All

Ages: 55 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants must have completed study CN012-0023 or CN012-0024 per protocol.
• Participants must have one identified caregiver who should have sufficient contact (approximately 10 hours a week or more).

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

600 participants in 1 patient group

KarXT+KarX-EC

Experimental group

Treatment:

Drug: KarXT

Drug: KarX-EC