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-2)
This study tests whether a combination medication called KarXT + KarX-EC can safely reduce agitation in people with Alzheimer's disease. Agitation is a common symptom that can make it difficult for patients and caregivers. Researchers will compare this new treatment to a placebo to see if it works better.
Key Objective:This trial is testing whether KarXT + KarX-EC can safely and effectively reduce agitation symptoms in Alzheimer's disease patients.
Who to Consider:Adults diagnosed with Alzheimer's disease who experience agitation or behavioral symptoms may want to consider participating in this study.
Trial Parameters
Eligibility Fast-Check
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Brief Summary
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.
Eligibility Criteria
Inclusion Criteria \- A diagnosis of Alzheimer's disease (AD) in accordance with the 2024 Alzheimer's Association criteria with one of the following confirmations of AD pathology: i) Historical evidence of AD diagnosis with amyloid positron emission tomography (PET), Aβ42/40 ratio in CSF, pTau181/Aβ42 ratio in CSF or pTau217/Aβ42 ratio in plasma using an Health Authority (HA)-authorized diagnostic assay. ii) If no historical evidence available: A. A plasma biomarker will be assessed for eligibility if allowed per regulatory requirements. The test cutoff(s) will be based on diagnostic use approval. B. If a plasma biomarker assay cannot be used or if the assay result is inconclusive, conduct one the following: * Amyloid PET. * Aβ42/40 ratio or pTau181/Aβ42 ratio in CSF using an HA-authorized diagnostic assay. * Mini-Mental State Examination (MMSE) score of 5 to 22, inclusive, at Screening (Visit 1). * Have one identified caregiver who should have sufficient contact (approximately 10 hour