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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-1)

NCT ID: NCT07011732
Registry status: Recruiting
Study type: Interventional
Phase: Phase 3
Sponsor: Bristol-Myers Squibb
Conditions: Alzheimer Disease

Overview

ClinicalTrials.gov lists this study as Recruiting.

Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease

Enrollment: 426 participants (Estimated).

What is being studied

Drug: Placebo
Intervention: trospium chloride
Intervention: xanomeline
Drug: Xanomeline Enteric Capsule
Drug: Xanomeline/Trospium Chloride Capsule

Who may be eligible

Ages: 55 Years to 90 Years
Sex: All
Healthy volunteers accepted: No

ClinicalTrials.gov lists the following 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 ≤ 24 at Screening (Visit 1). * Have an identified caregiver who has sufficient contact (approximately 8 hours over a week) and is willing to: i) Attend all visits and report on participant's status. ii) Oversee participant compliance with medication and study procedures. iii) Participate in the study assessments and provide informed consent to participate in the study. * History of agitation that meets the International Psychogeriatric Association (IPA) consensus definition for agitation in cognitive disorders with onset at least two weeks prior to Screening (Visit 1). * AD participants are required to have NPI/NPI-NH Agitation/Aggression score ≥ 4 at Screening (Visit 1) and Baseline (Visit 2). * CMAI-IPA Total Score ≥ 30 at Screening (Visit 1) and Baseline (Visit 2). Exclusion Criteria \- Medical Conditions: i) Agitation symptoms that are primarily attributable to a condition other than the AD causing the dementia. ii) History of bipolar disorder, schizophrenia, or schizoaffective disorder. iii) History of (or at high risk for) urinary retention, gastric retention, or narrow-angle glaucoma as evaluated by the Investigator. iv) Risk of suicidal behavior during the study as determined by the Investigator's clinical assessment and/or C-SSR. \- Prior/Concomitant Therapy: i) Recent history of receiving monoamine oxidase inhibitors, anticonvulsants (eg, lamotrigine, divalproex), mood stabilizers (eg, lithium), tricyclic antidepressants (eg, imipramine, desipramine), or any other psychoactive medications except for as needed anxiolytics (eg, lorazepam). A. Selective serotonin reuptake inhibitors and serotonin norepinephrine reuptake inhibitors taken at a stable dose for at least 8 weeks prior to Screening (Visit 1) may be permitted. B. Trazodone may be used as a hypnotic or for agitation if started at least 8 weeks prior to Screening (Visit 1). C. Mirtazapine may be used as a hypnotic if started at least 8 weeks prior to Screening (Visit 1). \- Other protocol-defined Inclusion/Exclusion criteria apply.

Study locations

157 study locations are listed.

Recruiting site status is explicitly provided for 157 locations; 114 are listed as Recruiting.

Countries: Argentina, Brazil, Bulgaria, Canada, China, Croatia, Greece, India, Japan, Mexico, Portugal, Romania, Spain, Taiwan, United States

Buenos Aires, Argentina: 2
Córdoba Province, Argentina: 1
Santa Fe Province, Argentina: 1
Federal District, Brazil: 1
Paraná, Brazil: 2
Rio Grande do Sul, Brazil: 2
São Paulo, Brazil: 1
Ontario, Canada: 6
Quebec, Canada: 1
Beijing Municipality, China: 3
Chongqing Municipality, China: 1
Guangdong, China: 2
Guangzhou Province, China: 1
Hunan, China: 1
Jiangsu, China: 1
Shanghai Municipality, China: 2
Shanxi, China: 1
Sichuan, China: 1
Tianjin Municipality, China: 1
Zhejiang, China: 1
City of Zagreb, Croatia: 2
Achaḯa, Greece: 1
Attica, Greece: 1
Attikí, Greece: 2
Gujarat, India: 1
Telangana, India: 1
Uttar Pradesh, India: 1
West Bengal, India: 1
Kanagawa, Japan: 2
Osaka, Japan: 1

Sample of listed locations

CEN Centro Especializado en Neurociencias — Córdoba, Córdoba Province, 5004, Argentina — Recruiting
Fundacion Estudios Clinicos — Rosario, Santa Fe Province, S2000DEJ, Argentina — Recruiting
Fundación para la Lucha contra las Enfermedades Neurológicas de la Infancia (FLENI) — Buenos Aires, C1428AQK, Argentina — Recruiting
Centro Medico Luquez — Córdoba, 5006, Argentina — Recruiting
Instituto Privado Kremer — Córdoba, 5004, Argentina — Recruiting
L2IP - Instituto de Pesquisas Clínicas — Brasília, Federal District, 70200730, Brazil — Recruiting
CECPAR - Centro de Estudos Clínicos do Paraná — Curitiba, Paraná, 80030-310, Brazil — Recruiting
PUCTrials — Curitiba, Paraná, 80230-130, Brazil — Recruiting
Hospital Moinhos de Vento — Porto Alegre, Rio Grande do Sul, 90560-032, Brazil — Recruiting
Nucleo de Pesquisa Clinica do Rio Grande do Sul — Porto Alegre, Rio Grande do Sul, 90430-001, Brazil — Recruiting
Instituto de Pesquisa Clínica de Campinas — Campinas, São Paulo, 13060-080, Brazil — Recruiting
Ruschel Medicina e Pesquisa Clínica — Rio de Janeiro, 22270-060, Brazil — Recruiting
Clinica Viver - Centro de Desospitalizacao Humana — São Paulo, 04020-060, Brazil — Recruiting
CPQuali Pesquisa Clínica — São Paulo, 01228-000, Brazil — Recruiting
Medical Center Medconsult Pleven OOD — Pleven, 5800, Bulgaria — Recruiting
Outpatient Clinic for Individual Practice for Specialized Medical Care in Psychiatry - Dr. Madlena Dimitrova Borisova — Razgrad, 7200, Bulgaria — Recruiting
Medical Center Sveti Naum EOOD — Sofia, 1113, Bulgaria — Recruiting
Medical Center Mladost — Varna, 9020, Bulgaria — Recruiting
London Health Sciences Centre-Victoria Campus — London, Ontario, N6A 5W9, Canada — Recruiting
Centre for Addiction & Mental Health — Toronto, Ontario, M6J 1H4, Canada — Recruiting
Sunnybrook Research Institute — Toronto, Ontario, M4N 3M5, Canada — Recruiting
Ontario Shores Centre For Mental Health Sciences — Whitby, Ontario, L1N 5S9, Canada — Recruiting
Beijing Anding Hospital Capital Medical University — Beijing, Beijing Municipality, 100088, China — Recruiting
Xuanwu Hospital Capital Medical University — Beijing, Beijing Municipality, 100053, China — Recruiting
Peking University Sixth Hospital — Haidian District, Beijing Municipality, 100191, China — Recruiting

Study details

Start date: July 10, 2025
Primary completion date: November 24, 2028
Completion date: December 8, 2028
First posted: June 10, 2025

Source and update information

Source: ClinicalTrials.gov
NCT ID: NCT07011732
Registry last updated: September 16, 2026
QualifiedStudies registry data refreshed: September 28, 2026
QualifiedStudies record fetched: September 28, 2026

View NCT07011732 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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