A Study to Evaluate the Efficacy and Safety of KarXT + KarX-EC for Cognitive Impairment in Alzheimer's Disease (MINDSET 2)

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 could affect safety or interfere with study procedures.
* Other protocol-defined Inclusion/Exclusion criteria apply.

Sites (126)

• Fullerton Neurology and Headache Center, Fullerton, California · RECRUITING
• Irvine Clinical Research, Irvine, California · RECRUITING
• Inglewood Clinical, Los Angeles, California · RECRUITING
• Stanford Neuroscience Health Center, Palo Alto, California · RECRUITING
• Local Institution - 0069, San Diego, California · WITHDRAWN
• Research of the Rockies, Colorado Springs, Colorado · RECRUITING
• Neuropsychiatric Research Center of Southwest Florida, Fort Myers, Florida · RECRUITING
• Local Institution - 0086, Hallandale, Florida · COMPLETED
• Jacksonville Center for Clinical Research, Jacksonville, Florida · RECRUITING
• K2 MEDICAL Research THE VILLAGES, Lady Lake, Florida · RECRUITING
• Intercoastal Medical Group, Sarasota, Florida · RECRUITING
• USF Health Byrd Alzheimer's Institute, Tampa, Florida · RECRUITING
• Alzheimer's Research and Treatment Center, Wellington, Florida · RECRUITING
• Great Lakes Clinical Trials - Andersonville, Chicago, Illinois · RECRUITING
• Southern Illinois University School of Medicine, Springfield, Illinois · RECRUITING
• Josephson Wallack Munshower Neurology, PC, Indianapolis, Indiana · RECRUITING
• Local Institution - 0080, Watertown, Massachusetts · NOT_YET_RECRUITING
• QUEST Research Institute, Farmington Hills, Michigan · RECRUITING
• Private Practice - Dr. Ronald Louis Schwartz, Hattiesburg, Mississippi · RECRUITING
• Local Institution - 0119, Ridgewood, New Jersey · WITHDRAWN
• The Cognitive and Research Center of New Jersey, Springfield, New Jersey · RECRUITING
• Advanced Clinical Institute, West Long Branch, New Jersey · RECRUITING
• Neurological Associates Albany, Albany, New York · RECRUITING
• Dent Neurosciences Research Center, Inc, Amherst, New York · RECRUITING
• University at Buffalo - UBMD Neurology, Buffalo, New York · RECRUITING
• Local Institution - 0078, Lake Success, New York · WITHDRAWN
• Keystone Clinical Studies, Plymouth Meeting, Pennsylvania · RECRUITING
• Local Institution - 0081, Dallas, Texas · NOT_YET_RECRUITING
• Central Texas Neurology Consultants, PA, Round Rock, Texas · RECRUITING
• Local Institution - 0076, Renton, Washington · COMPLETED
• Hospital Italiano de Buenos Aires, ABB, Buenos Aires F.D., Argentina · RECRUITING
• Centro Médico Luquez, Córdoba, Córdoba Province, Argentina · RECRUITING
• Local Institution - 0025, Buenos Aires, Argentina · NOT_YET_RECRUITING
• CEN Centro Especializado en Neurociencias, Córdoba, Argentina · RECRUITING
• Instituto Médico DAMIC, Córdoba, Argentina · RECRUITING
• Resolution Psychopharmacology Research Institute, Mendoza, Argentina · RECRUITING
• University of the Sunshine Coast Birtinya, Birtinya, Queensland, Australia · RECRUITING
• Local Institution - 0055, Herston (rbwh Grounds), Queensland, Australia · NOT_YET_RECRUITING
• Griffith University - Gold Coast Campus, Southport, Queensland, Australia · RECRUITING
• Austin Health, Ivanhoe, Victoria, Australia · RECRUITING
• Local Institution - 0115, Fortaleza, Ceará, Brazil · NOT_YET_RECRUITING
• Local Institution - 0101, Maringá, Paraná, Brazil · NOT_YET_RECRUITING
• Ruschel Medicina e Pesquisa Clínica, Rio de Janeiro, Brazil · RECRUITING
• CPQuali Pesquisa Clínica, São Paulo, Brazil · RECRUITING
• Terveystalo Oulu, Oulu, North Ostrobothnia, Finland · RECRUITING
• Clinical Research Services Turku, Turku, Southwest Finland, Finland · RECRUITING
• CRST Helsinki Oy, Helsinki, Uusimaa, Finland · RECRUITING
• Terveystalo Ruoholahti, Helsinki, Finland · RECRUITING
• Itä-Suomen Yliopisto Kuopio, Kuopio, Finland · RECRUITING
• Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone, Marseille, Bouches-du-Rhône, France · RECRUITING
• Local Institution - 0128, Tours, Centre-Val de Loire, France · NOT_YET_RECRUITING
• Centre Hospitalier Universitaire Toulouse - Cité de la Santé, Toulouse, Haute-Garonne, France · RECRUITING
• Centre Hospitalier Régional Universitaire de Lille - Hôpital Roger Salengro, Lille, Hauts-de-France, France · RECRUITING
• Centre Hospitalier Universitaire de Rennes - Hôpital Pontchaillou, Rennes, Ille-et-Vilaine, France · RECRUITING
• Local Institution - 0127, Saint-Herblain, Loire-Atlantique, France · NOT_YET_RECRUITING
• Centre Hospitalier Universitaire Régional de Nancy, Nancy, Meurthe-et-Moselle, France · RECRUITING
• Hospices Civils de Lyon - Hôpital Pierre Wertheimer, Bron, Rhône, France · RECRUITING
• Local Institution - 0017, Villefranche-sur-Saône, Rhône, France · WITHDRAWN
• Bordeaux University Hospital - Pellegrin, Bordeaux, France · RECRUITING
• Assistance Publique Hôpitaux de Paris - Groupe Hospitalier 10e - Hôpital Lariboisière, Paris, France · RECRUITING
• Hôpital Broca, Paris, France · RECRUITING
• Pitie Salpetriere University Hospital, Paris, France · RECRUITING
• Les Hôpitaux Universitaires de Strasbourg - Hôpital de la Robertsau, Strasbourg, France · RECRUITING
• Ludwig-Maximilians-Universität München, Munich, Bavaria, Germany · RECRUITING
• Universitätsmedizin Göttingen - Georg-August-Universität, Göttingen, Lower Saxony, Germany · RECRUITING
• Private Practice - Dr. Irma Schöll, Bad Homburg, Germany · RECRUITING
• Pharmakologisches Studienzentrum Chemnitz, Chemnitz, Germany · RECRUITING
• Universitaetsklinikum Koeln, Cologne, Germany · RECRUITING
• Universitaetsklinikum Ulm, Ulm, Germany · RECRUITING
• University Hospital of Patras, Pátrai, Achaḯa, Greece · RECRUITING
• University General Hospital "ATTIKON" - General Hospital of West Attica "H AGIA VARVARA", Chaïdári, Attikí, Greece · RECRUITING
• Hygeia Hospital, Marousi, Attikí, Greece · RECRUITING
• Local Institution - 0059, Ioannina, Ioánnina, Greece · NOT_YET_RECRUITING
• AHEPA University General Hospital of Thessaloniki, Thessaloniki, Greece · RECRUITING
• University of Naples Federico II, Naples, Campania, Italy · RECRUITING
• Azienda Ospedaliero Universitaria Policlinico Riuniti di Foggia, Foggia, Italy · RECRUITING
• Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore, Roma, Italy · RECRUITING
• Inage Neurology and Memory Clinic, Inage, Chiba, Japan · RECRUITING
• Local Institution - 0123, Matsudo, Chiba, Japan · NOT_YET_RECRUITING
• Imon Yukari Neurology Clinic, Hiroshima, Hiroshima, Japan · RECRUITING
• Kagawa University Hospital, Kita-gun, Kagawa-ken, Japan · RECRUITING
• Local Institution - 0125, Kamakura, Kanagawa, Japan · NOT_YET_RECRUITING
• Kokankai Kokan Clinic, Kawasaki, Kanagawa, Japan · RECRUITING
• Nippon Medical School Musashi Kosugi Hospital, Kawasaki, Kanagawa, Japan · RECRUITING
• Ina Central Hospital, Ina, Nagano, Japan · RECRUITING
• National Hospital Organization Niigata Hospital, Kashiwazaki, Niigata, Japan · RECRUITING
• Katayama Medical Clinic, Kurashiki, Okayama-ken, Japan · RECRUITING
• Tominaga Clinic, Osaka, Osaka, Japan · RECRUITING
• National Hospital Organization Hizen Psychiatric Center, Yoshinogari-cho, Kanzaki-gun, Saga-ken, Japan · RECRUITING
• Local Institution - 0037, Wako, Saitama, Japan · WITHDRAWN
• Wako Hospital, Wako, Saitama, Japan · RECRUITING
• Local Institution - 0107, Kyoto, Japan · NOT_YET_RECRUITING
• Brain Research Center Den Bosch B.V., 's-Hertogenbosch, North Brabant, Netherlands · RECRUITING
• Brain Research Center, Amsterdam, North Holland, Netherlands · RECRUITING
• Brain Research Center Zwolle, Zwolle, Overijssel, Netherlands · RECRUITING
• Instytut Zdrowia Dr Boczarska Jedynak, Oświęcim, Lesser Poland Voivodeship, Poland · RECRUITING
• Penta Hospitals Przychodnie, Wrocław Wejherowska, Wroclaw, Lower Silesian Voivodeship, Poland · RECRUITING
• Local Institution - 0108, Lublin, Lublin Voivodeship, Poland · WITHDRAWN
• EMC Silesia sp. z o.o., Katowice, Silesian Voivodeship, Poland · RECRUITING
• Campus Neurológico Sénior, Torres Vedras, Lisbon District, Portugal · RECRUITING
• Unidade Local de Saude de Matosinhos, Matosinhos Municipality, Porto District, Portugal · RECRUITING
• Hospital de Braga, Braga, Portugal · RECRUITING
• Unidade Local de Saúde de Coimbra, E.P.E., Coimbra, Portugal · RECRUITING
• Centro Hospitalar do Alto Ave - Hospital Senhora da Oliveira, Guimarães, Portugal · RECRUITING
• Centro Hospitalar do Porto - Hospital de Santo António, Porto, Portugal · RECRUITING
• SCB Research Center, Bayamón, Puerto Rico · RECRUITING
• Prof. Dr. Alexandru Obregia Psychiatry Hospital, Bucharest, Bucharest, Romania · RECRUITING
• Prof. Dr. Alexandru Obregia Psychiatry Hospital, Bucharest, Bucharest, Romania · RECRUITING
• Local Institution - 0113, Constanța, Constanța County, Romania · NOT_YET_RECRUITING
• Local Institution - 0042, Bucharest, Romania · WITHDRAWN
• Spitalul de Psihiatrie și Neurologie Brașov, Sanpetru /Brasov, Romania · RECRUITING
• Fundació ACE, Barcelona, Barcelona [Barcelona], Spain · RECRUITING
• Policlinica Gipuzkoa, Donostia / San Sebastian, Basque Country, Spain · RECRUITING
• Hospital Universitario Marqués de Valdecilla, Santander, Cantabria, Spain · RECRUITING
• Hospital Universitario Quironsalud Madrid, Pozuelo de Alarcón, Madrid, Spain · RECRUITING
• Hospital Universitario Doctor Peset, Valencia, Valenciana, Comunitat, Spain · RECRUITING
• Complejo Hospitalario Ruber Juan Bravo, Madrid, Spain · RECRUITING
• Hospital Universitario 12 de Octubre, Madrid, Spain · RECRUITING
• NIHR Manchester Clinical Research Facility, Manchester, England, United Kingdom · RECRUITING
• The Maudsley Hospital, London, London, City of, United Kingdom · RECRUITING
• Local Institution - 0103, Edinburgh, Midlothian, United Kingdom · NOT_YET_RECRUITING
• Warneford Hospital, Oxford, Oxfordshire, United Kingdom · RECRUITING
• Re:Cognition Health - Birmingham, Birmingham, United Kingdom · RECRUITING
• Leeds and York Partnership NHS Foundation Trust, Leeds, United Kingdom · RECRUITING
• NeuroClin Glasgow, Motherwell, United Kingdom · RECRUITING
• Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, United Kingdom · RECRUITING