A Study to Evaluate the Efficacy and Safety of KarXT + KarX-EC for Cognitive Impairment in Alzheimer's Disease

Summary

The purpose of this study is to evaluate the efficacy and safety of KarXT + KarX-EC for cognitive impairment in Alzheimer's Disease

Interventions

• KarXT · DRUG

  Specified dose on specified days

• KarX-EC · DRUG

  Specified dose on specified days

• Placebo · OTHER

  Specified dose on specified days

Published eligibility criteria

Verbatim from the registry. Only the site can decide how these apply to a specific patient.

Inclusion Criteria

* Participants must have a confirmed diagnosis of Alzheimer's disease (AD), specifically at the mild (stage 4) or moderate (stage 5) dementia stages, as defined by the National Institute on Aging and Alzheimer's Association (NIA-AA) core clinical criteria. The diagnosis of AD pathology must be confirmed through the 2024 revised NIA-AA Workgroup criteria using a stepwise diagnostic approach.
* Participants must have an Mini-Mental State Examination (MMSE) score ranging from 12 through 22, inclusive, at the time of screening.
* Participants must have a designated caregiver who maintains adequate contact (around 10 hours per week or more) and is willing to attend all study visits. The caregiver must also be responsible for reporting on the participant's condition, overseeing medication compliance, and consenting to their involvement in both their own and the participant's study-related activities.
* Participants on acetyl choline esterase inhibitors (AChEIs) and/or memantine, must have been on a stable dosage for at least 12 weeks prior to screening, and agree to maintain this stable dose for the study duration.

Exclusion Criteria

* Participants must not present with any significant or severe medical conditions that could compromise their safety, the ability to comply with or complete the study, or the integrity of the study results. This includes any grade of hepatic impairment, urinary retention, active biliary disease, moderate-severe renal impairment (eGFR of \<50 mL/min), and unstable hypertension or tachycardia.
* Participants must not have any primary psychiatric diagnoses such as major depression, schizoaffective disorder, or bipolar disorder, and those with severe psychiatric symptoms that could complicate the interpretation of treatment effects, impair cognitive assessment, or impact study completion.
* Participants must not have a history of schizophrenia or other chronic psychosis, as well as those who have previously been exposed to KarXT or are currently undergoing treatment with disease-modifying anti-amyloid therapies for AD within the past 6 months prior to screening.
* Participants must not have significant pathological findings on brain magnetic resonance imaging (MRI) at screening that reflect significant pathology other than AD or could affect safety or interfere with study procedures.
* Other protocol-defined Inclusion/Exclusion criteria apply.

Sites (119)

• Healthy Brain Clinic, Long Beach, California · Recruiting
• Anderson Clinical Research, Redlands, California · Recruiting
• Mountain Neurological Research Center, Basalt, Colorado · Recruiting
• Georgetown University Medical Center, Washington D.C., District of Columbia · Recruiting
• JEM Research Institute, Atlantis, Florida · Recruiting
• VIN-Julie Schwartzbard, Aventura, Florida · Recruiting
• Merritt Island Medical Research, LLC, Merritt Island, Florida · Recruiting
• Renstar Medical Research, Ocala, Florida · Recruiting
• Alzheimer's Research and Treatment Center, Stuart, Florida · Recruiting
• Charter Research - Lady Lake, The Villages, Florida · Recruiting
• Local Institution - 0016, Columbus, Georgia · Withdrawn
• Center for Advanced Research & Education, Gainesville, Georgia · Recruiting
• Re:Cognition Health - Chicago, Chicago, Illinois · Recruiting
• Ascension Alexian Brothers, Elk Grove Village, Illinois · Recruiting
• Boston Center for Memory, Newton, Massachusetts · Recruiting
• HealthPartners Neuroscience Center, Saint Paul, Minnesota · Recruiting
• Advanced Memory Research Institute of New Jersey, Toms River, New Jersey · Recruiting
• NYU Langone Health, New York, New York · Recruiting
• Local Institution - 0259, New York, New York · Active, not recruiting
• SUNY Upstate Medical University, Syracuse, New York · Recruiting
• AMC Research, LLC, Matthews, North Carolina · Recruiting
• Ohio State University, Columbus, Ohio · Recruiting
• NDx Clinical Research Inc., Dayton, Ohio · Recruiting
• Summit Headlands, Portland, Oregon · Recruiting
• Local Institution - 0004, Abington, Pennsylvania · Withdrawn
• Rhode Island Mood & Memory Research Institute, East Providence, Rhode Island · Recruiting
• Neurology Clinic, P.C., Cordova, Tennessee · Recruiting
• Gadolin Research, Beaumont, Texas · Recruiting
• Fundación para el Estudio y Tratamiento de Enfermedades Mentales (FETEM), Buenos Aires, Buenos Aires F.D. · Recruiting
• Local Institution - 0271, Buenos Aires, Argentina · Not yet recruiting
• Fundación Lennox - Instituto Modelo de Neurología, Córdoba, Argentina · Recruiting
• Sanatorio Morra S.A., Córdoba, Argentina · Recruiting
• Instituto Kremer, Córdoba, Argentina · Recruiting
• Southern Neurology, Kogarah, New South Wales · Recruiting
• KARA Institute for Neurological Diseases, Macquarie Park, New South Wales · Recruiting
• NeuroCentrix, Carlton, Victoria · Recruiting
• Neurodegenerative Disorders Research, Perth, Western Australia · Recruiting
• St Vincent's Hospital Sydney Limited, Darlinghurst, Australia · Recruiting
• Local Institution - 0168, Brasília, Federal District · Not yet recruiting
• Instituto de Neurologia de Curitiba, Curitiba, Paraná · Recruiting
• Local Institution - 0266, Aracaju, Sergipe · Not yet recruiting
• Hospital das Clinicas FMUSP, São Paulo, Brazil · Recruiting
• OCT Research ULC, Kelowna, British Columbia · Recruiting
• Richmond Clinical Trials, Richmond, British Columbia · Recruiting
• Centricity Research Halifax Multispecialty, Halifax, Nova Scotia · Recruiting
• Ottawa Memory Clinic, Ottawa, Ontario · Recruiting
• Toronto Memory Program, Toronto, Ontario · Recruiting
• MoCA Research and Innovation Inc., Greenfield Park, Quebec · Recruiting
• Diex Recherche Victoriaville, Victoriaville, Quebec · Recruiting
• ALPHA Recherche Clinique, Québec, Canada · Recruiting
• Local Institution - 0094, Santiago, Santiago Metropolitan · Not yet recruiting
• Local Institution - 0089, Santiago, Santiago Metropolitan · Not yet recruiting
• Local Institution - 0241, Santiago, Santiago Metropolitan · Not yet recruiting
• Local Institution - 0230, Antofagasta, Chile · Not yet recruiting
• Local Institution - 0215, Zagreb, City of Zagreb · Not yet recruiting
• Poliklinika Neuron, Zagreb, City of Zagreb · Recruiting
• Klinika za psihijatriju "Vrapče", Zagreb, Croatia · Recruiting
• Neuro Health Centrum, Brno, Brno-město · Recruiting
• AGE Centrum, Olomouc, Olomouc Region · Recruiting
• A-Shine, Pilsen, Plzeň-město · Recruiting
• Neurologická Ambulance - Forbeli, Prague, Praha 6 · Recruiting
• Neuropsychiatrie, Prague, Praha 6 · Recruiting
• Local Institution - 0222, Prague, Praha 8 · Active, not recruiting
• Vestra Clinics, Rychnov nad Kněžnou, Czechia · Recruiting
• Local Institution - 0295, Nice, Alpes-Maritimes · Not yet recruiting
• Local Institution - 0289, Toulouse, Haute-Garonne · Not yet recruiting
• Local Institution - 0290, Rouen, Haute-Normandie · Not yet recruiting
• Local Institution - 0291, Montpellier, Languedoc-Roussillon · Not yet recruiting
• Local Institution - 0299, Reims, Marne · Not yet recruiting
• Local Institution - 0293, Villeurbanne, Rhône · Not yet recruiting
• Local Institution - 0294, Dijon, France · Not yet recruiting
• Local Institution - 0301, Mannheim, Baden-Wurttemberg · Not yet recruiting
• Universitätsklinikum Münster - Albert Schweitzer Campus, Münster, North Rhine-Westphalia · Recruiting
• Universitätsmedizin Johannes Gutenberg Universität Mainz, Mainz, Rhineland-Palatinate · Recruiting
• Charite-Universitaetsmedizin Berlin - Campus Benjamin Franklin (CBF), Berlin, State of Berlin · Recruiting
• Local Institution - 0300, Aachen, Germany · Not yet recruiting
• Local Institution - 0302, Berlin, Germany · Not yet recruiting
• Local Institution - 0277, Bremen, Germany · Withdrawn
• Local Institution - 0275, Hamburg, Germany · Withdrawn
• TUM Klinikum, Munich, Germany · Recruiting
• University General Hospital of Alexandroupoli, Alexandroupoli, Anatolikí Makedonía Kai Thráki · Recruiting
• Local Institution - 0256, Athens, Attikí · Withdrawn
• Aiginiteio University Hospital, Athens, Attikí · Recruiting
• University General Hospital of Larissa, Larissa, Thessalía · Recruiting
• Local Institution - 0288, Bengaluru, Karnataka · Not yet recruiting
• Local Institution - 0282, Hyderabad, Telangana · Not yet recruiting
• Local Institution - 0285, Hyderabad, Telangana · Not yet recruiting
• Local Institution - 0287, Varanasi, Uttar Pradesh · Not yet recruiting
• Local Institution - 0286, Kolkata, West Bengal · Not yet recruiting
• Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, Milan, Lombardy · Recruiting
• Ospedale San Raffaele, Milan, Lombardy · Recruiting
• Fondazione IRCCS San Gerardo dei Tintori, Monza, Lombardy · Recruiting
• Azienda Ospedaliera Spedali Civili di Brescia, Brescia, Italy · Recruiting
• Local Institution - 0296, 's-Hertogenbosch, North Brabant · Not yet recruiting
• Local Institution - 0297, Amsterdam, North Holland · Not yet recruiting
• Local Institution - 0298, Zwolle, Overijssel · Not yet recruiting
• Centrum Medyczne HCP, Poznan, Greater Poland Voivodeship · Recruiting
• Osrodek Badan Klinicznych CLINSANTE S.C., Torun, Kuyavian-Pomeranian Voivodeship · Recruiting
• MlynowaMed Psychiatric, Bialystok, Podlaskie Voivodeship · Recruiting
• Penta Hospitals Badania Kliniczne - Gdańsk 1, Gdansk, Pomeranian Voivodeship · Recruiting
• Instituto De Neurologia Dra. Ivonne Fraga, San Juan, Puerto Rico · Recruiting
• Prof. Dr. Alexandru Obregia Psychiatry Hospital, Bucharest, Bucharest · Recruiting
• Prof. Dr. Alexandru Obregia Psychiatry Hospital, Bucharest, Bucharest · Recruiting
• Institutul Național de Gerontologie și Geriatrie "Ana Aslan", Bucharest, Romania · Recruiting
• Centrul de Sanatate Mintala, Bucharest, Romania · Recruiting
• Institutul de Psihiatrie Socola, Iași, Romania · Recruiting
• Chonnam National University Hospital, Gwangju, Kwangju-Kwangyǒkshi · Recruiting
• Seoul National University Bundang Hospital, Seongnam, Kyǒnggi-do · Recruiting
• Seoul National University Hospital, Seoul, Seoul-teukbyeolsi [Seoul] · Recruiting
• Hanyang University Seoul Hospital, Seoul, Seoul-teukbyeolsi [Seoul] · Recruiting
• Konkuk University Medical Center, Seoul, Seoul-teukbyeolsi [Seoul] · Recruiting
• Samsung Medical Center, Seoul, Seoul-teukbyeolsi [Seoul] · Recruiting
• Ewha Womans University Seoul Hospital, Seoul, Seoul-teukbyeolsi [Seoul] · Recruiting
• Hospital Victoria Eugenia, Seville, Andalusia · Recruiting
• Hospital Universitari General de Catalunya, Sant Cugat del Vallès, Barcelona [Barcelona] · Recruiting
• Hospital Clínic de Barcelona, Barcelona, Catalunya [Cataluña] · Recruiting
• Hospital Universitari de Santa Maria, Lleida, Lleida [Lérida] · Recruiting
• Clinica Universidad de Navarra, Pamplona, Navarre · Recruiting
• Hospital Clinico San Carlos, Madrid, Spain · Recruiting