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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

NCT ID: NCT07011745
Registry status: Recruiting
Study type: Interventional
Phase: Phase 3
Sponsor: Bristol-Myers Squibb
Conditions: Alzheimer's 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 (ADAGIO-2)

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). * Cohen-Mansfield Agitation Inventory-International Psychogeriatric Association (CMAI-IPA) Total Score ≥ 30 at Screening (Visit 1) and 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). Note: 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

144 study locations are listed.

Recruiting site status is explicitly provided for 144 locations; 95 are listed as Recruiting.

Countries: Argentina, Chile, Czechia, France, Germany, Hungary, Israel, Italy, Poland, Puerto Rico, South Korea, Ukraine, United Kingdom, United States

Buenos Aires, Argentina: 1
Córdoba Province, Argentina: 1
Santiago Metropolitan, Chile: 4
Valparaiso, Chile: 1
Olomouc Region, Czechia: 1
Praha 6, Czechia: 1
Praha 8, Czechia: 1
South Moravian, Czechia: 1
Haute-Garonne, France: 1
Rhône, France: 1
Bács-Kiskun county, Hungary: 1
Győr-Moson-Sopron, Hungary: 1
Hajdú-Bihar, Hungary: 1
Heves County, Hungary: 1
Central District, Israel: 1
IL, Israel: 1
Campania, Italy: 1
Lazio, Italy: 2
Lombardy, Italy: 1
PI, Italy: 1
Greater Poland Voivodeship, Poland: 1
Kuyavian-Pomeranian Voivodeship, Poland: 1
Incheon Gwang'yeogsi, South Korea: 1
Seoul-teukbyeolsi [Seoul], South Korea: 3
Taegu-Kwangyǒkshi, South Korea: 1
Cherkasy Oblast, Ukraine: 1
Dnipropetrovsk Oblast, Ukraine: 1
Khmelnytskyi Oblast, Ukraine: 1
Kyiv Oblast, Ukraine: 1
Lviv Oblast, Ukraine: 1

Sample of listed locations

Centro Neurobiológico y de Estrés Traumático - CENydET S.R.L. — Ciudad Autonoma de Buenos Aires, Buenos Aires, 1058, Argentina — Recruiting
Fundacion para el Estudio y Tratamiento de Enfermedades mentales- FETEM — Buenos Aires, 1133, Argentina — Recruiting
Hospital Italiano de Buenos Aires (HIBA) — Buenos Aires, 1199, Argentina — Recruiting
Instituto Médico DAMIC — Córdoba, X5003DCE, Argentina — Recruiting
Instituto Modelo de Neurología, Fundación Lennox — Córdoba, 5000, Argentina — Recruiting
Sanatorio Morra S.A. — Córdoba, 5000, Argentina — Recruiting
Resolution Psychopharmacology Research Institute — Mendoza, 5502, Argentina — Recruiting
Biomedica Research Group — Santiago, Santiago Metropolitan, 7500710, Chile — Recruiting
Pontificia Universidad Catolica de Chile — Santiago, Santiago Metropolitan, 8330024, Chile — Recruiting
Clinica Alemana — Vitacura, Santiago Metropolitan, 2511433, Chile — Recruiting
Psicomed Estudios Médicos Cía Ltda — Antofagasta, 1270244, Chile — Recruiting
AGE Centrum — Olomouc, Olomouc Region, 779 00, Czechia — Recruiting
Neuropsychiatrie — Prague, Praha 6, 160 00, Czechia — Recruiting
Institut neuropsychiatricke pece (INEP), Praha — Prague, Praha 8, 18600, Czechia — Recruiting
Neuro Health Centrum s.r.o. — Brno, South Moravian, 628 00, Czechia — Recruiting
NEUROHK — Choceň, 565 01, Czechia — Recruiting
A-SHINE s.r.o. — Pilsen, 301 00, Czechia — Recruiting
Vestra Clinics s.r.o. — Rychnov nad Kněžnou, 516 01, Czechia — Recruiting
Centre Hospitalier Universitaire Toulouse - Cité de la Santé — Toulouse, Haute-Garonne, 31000, France — Recruiting
Hôpital des Charpennes - Hospices Civils de Lyon (HCL) — Villeurbanne, Rhône, 69100, France — Recruiting
Centre Hospitalier Régional Universitaire de Lille - Hôpital Roger Salengro — Lille, 59037, France — Recruiting
Centre Hospitalier Universitaire de Limoges - Hôpital Dupuytren — Limoges, 87042, France — Recruiting
Hopital Gui Chauliac - Chu Montpellier — Montpellier, 34295, France — Recruiting
Centres Memoire de Ressources et de Recherche (CMRR) - Hopital Lariboisiere-Fernand-Widal Location — Paris, 75010, France — Recruiting
Les Hôpitaux Universitaires de Strasbourg - Hôpital de la Robertsau — Strasbourg, 67091, France — Recruiting

Study details

Start date: July 16, 2025
Primary completion date: November 3, 2028
Completion date: November 13, 2028
First posted: June 10, 2025

Source and update information

Source: ClinicalTrials.gov
NCT ID: NCT07011745
Registry last updated: September 16, 2026
QualifiedStudies registry data refreshed: September 28, 2026
QualifiedStudies record fetched: September 28, 2026

View NCT07011745 on ClinicalTrials.gov

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

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