A Study to Evaluate the Efficacy and Safety of KarXT + KarX-EC for Cognitive Impairment in Alzheimer's Disease (MINDSET 2) | NCT06976203 | Trialant

A Study to Evaluate the Efficacy and Safety of KarXT + KarX-EC for Cognitive Impairment in Alzheimer's Disease (MINDSET 2) | NCT06976203 | Trialant

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Eligibility Criteria: 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.

Fullerton Neurology and Headache CenterRecruiting

Fullerton, California 92835, United States

Jack Florin, Site 0072Contact

714-381-0801

Irvine Clinical ResearchRecruiting

Irvine, California 92614, United States

Inglewood ClinicalRecruiting

Los Angeles, California 90056, United States

Stanford Neuroscience Health CenterRecruiting

Palo Alto, California 94304, United States

Local Institution - 0069Withdrawn

San Diego, California 92103, United States

Research of the RockiesRecruiting

Colorado Springs, Colorado 80919, United States

Neuropsychiatric Research Center of Southwest FloridaRecruiting

Fort Myers, Florida 33912, United States

Local Institution - 0086Completed

Hallandale, Florida 33009, United States

Jacksonville Center for Clinical ResearchRecruiting

Jacksonville, Florida 32216, United States

K2 MEDICAL Research THE VILLAGESRecruiting

Lady Lake, Florida 32159, United States

Intercoastal Medical GroupRecruiting

Sarasota, Florida 34239, United States

USF Health Byrd Alzheimer's InstituteRecruiting

Tampa, Florida 33613, United States

Alzheimer's Research and Treatment CenterRecruiting

Wellington, Florida 33414, United States

Great Lakes Clinical Trials - AndersonvilleRecruiting

Chicago, Illinois 60640, United States

Southern Illinois University School of MedicineRecruiting

Springfield, Illinois 62702, United States

Josephson Wallack Munshower Neurology, PCRecruiting

Indianapolis, Indiana 46256, United States

Local Institution - 0080Not yet recruiting

Watertown, Massachusetts 02472, United States

QUEST Research InstituteRecruiting

Farmington Hills, Michigan 48334, United States

Private Practice - Dr. Ronald Louis SchwartzRecruiting

Hattiesburg, Mississippi 39401, United States

Local Institution - 0119Withdrawn

Ridgewood, New Jersey 07450, United States

The Cognitive and Research Center of New JerseyRecruiting

Springfield, New Jersey 07081, United States

Advanced Clinical InstituteRecruiting

West Long Branch, New Jersey 07764, United States

Neurological Associates AlbanyRecruiting

Albany, New York 12208, United States

Dent Neurosciences Research Center, IncRecruiting

Amherst, New York 14226, United States

University at Buffalo - UBMD NeurologyRecruiting

Buffalo, New York 14203, United States

Local Institution - 0078Withdrawn

Lake Success, New York 11042, United States

Keystone Clinical StudiesRecruiting

Plymouth Meeting, Pennsylvania 19462, United States

Local Institution - 0081Not yet recruiting

Dallas, Texas 75231, United States

Central Texas Neurology Consultants, PARecruiting

Round Rock, Texas 78681, United States

Local Institution - 0076Completed

Renton, Washington 98057, United States

Hospital Italiano de Buenos AiresRecruiting

ABB, Buenos Aires F.D. 1181, Argentina

Daniel Bernardo Seinhart, Site 0029Contact

005491150416255

Centro Médico LuquezRecruiting

Córdoba, Córdoba Province X5006CBI, Argentina

Local Institution - 0025Not yet recruiting

Buenos Aires, C1428AQK, Argentina

CEN Centro Especializado en NeurocienciasRecruiting

Córdoba, 5000, Argentina

Instituto Médico DAMICRecruiting

Córdoba, X5003DCE, Argentina

Resolution Psychopharmacology Research InstituteRecruiting

Mendoza, 5502, Argentina

University of the Sunshine Coast BirtinyaRecruiting

Birtinya, Queensland 4575, Australia

Local Institution - 0055Not yet recruiting

Herston (rbwh Grounds), Queensland 4006, Australia

Griffith University - Gold Coast CampusRecruiting

Southport, Queensland 4222, Australia

Austin HealthRecruiting

Ivanhoe, Victoria 3079, Australia

Local Institution - 0115Not yet recruiting

Fortaleza, Ceará 60135-237, Brazil

Local Institution - 0101Not yet recruiting

Maringá, Paraná 87015-180, Brazil

Ruschel Medicina e Pesquisa ClínicaRecruiting

Rio de Janeiro, 22270-060, Brazil

CPQuali Pesquisa ClínicaRecruiting

São Paulo, 01228-000, Brazil

Terveystalo OuluRecruiting

Oulu, North Ostrobothnia 90100, Finland

Clinical Research Services TurkuRecruiting

Turku, Southwest Finland 20520, Finland

CRST Helsinki OyRecruiting

Helsinki, Uusimaa 00180, Finland

Terveystalo RuoholahtiRecruiting

Helsinki, 00180, Finland

Itä-Suomen Yliopisto KuopioRecruiting

Kuopio, 70210, Finland

Assistance Publique Hôpitaux de Marseille - Hôpital de la TimoneRecruiting

Marseille, Bouches-du-Rhône 13005, France

Local Institution - 0128Not yet recruiting

Tours, Centre-Val de Loire 37044 Cedex 8, France

Centre Hospitalier Universitaire Toulouse - Cité de la SantéRecruiting

Toulouse, Haute-Garonne 31000, France

Centre Hospitalier Régional Universitaire de Lille - Hôpital Roger SalengroRecruiting

Lille, Hauts-de-France 59037, France

Centre Hospitalier Universitaire de Rennes - Hôpital PontchaillouRecruiting

Rennes, Ille-et-Vilaine 35000, France

Local Institution - 0127Not yet recruiting

Saint-Herblain, Loire-Atlantique 44800, France

Centre Hospitalier Universitaire Régional de NancyRecruiting

Nancy, Meurthe-et-Moselle 54035, France

Hospices Civils de Lyon - Hôpital Pierre WertheimerRecruiting

Bron, Rhône 69500, France

Local Institution - 0017Withdrawn

Villefranche-sur-Saône, Rhône 69655, France

Bordeaux University Hospital - PellegrinRecruiting

Bordeaux, 33076, France

Assistance Publique Hôpitaux de Paris - Groupe Hospitalier 10e - Hôpital LariboisièreRecruiting

Paris, 75010, France

Hôpital BrocaRecruiting

Paris, 75013, France

Pitie Salpetriere University HospitalRecruiting

Paris, 75013, France

Les Hôpitaux Universitaires de Strasbourg - Hôpital de la RobertsauRecruiting

Strasbourg, 67091, France

Ludwig-Maximilians-Universität MünchenRecruiting

Munich, Bavaria 80539, Germany

Universitätsmedizin Göttingen - Georg-August-UniversitätRecruiting

Göttingen, Lower Saxony 37075, Germany

Private Practice - Dr. Irma SchöllRecruiting

Bad Homburg, 61348, Germany

Pharmakologisches Studienzentrum ChemnitzRecruiting

Chemnitz, 09111, Germany

Universitaetsklinikum KoelnRecruiting

Cologne, 50937, Germany

Universitaetsklinikum UlmRecruiting

Ulm, 89081, Germany

University Hospital of PatrasRecruiting

Pátrai, Achaḯa 26504, Greece

University General Hospital "ATTIKON" - General Hospital of West Attica "H AGIA VARVARA"Recruiting

Chaïdári, Attikí 124 62, Greece

Hygeia HospitalRecruiting

Marousi, Attikí 151 23, Greece

Local Institution - 0059Not yet recruiting

Ioannina, Ioánnina 455 00, Greece

AHEPA University General Hospital of ThessalonikiRecruiting

Thessaloniki, 546 36, Greece

University of Naples Federico IIRecruiting

Naples, Campania 80131, Italy

Azienda Ospedaliero Universitaria Policlinico Riuniti di FoggiaRecruiting

Foggia, 71100, Italy

Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro CuoreRecruiting

Roma, 00168, Italy

Inage Neurology and Memory ClinicRecruiting

Inage, Chiba 263-0043, Japan

Local Institution - 0123Not yet recruiting

Matsudo, Chiba 271-0047, Japan

Imon Yukari Neurology ClinicRecruiting

Hiroshima, Hiroshima 732-0066, Japan

Kagawa University HospitalRecruiting

Kita-gun, Kagawa-ken 761-0793, Japan

Ichiro Ishikawa, Site 0120Contact

81878912345

Local Institution - 0125Not yet recruiting

Kamakura, Kanagawa 247-8533, Japan

Kokankai Kokan ClinicRecruiting

Kawasaki, Kanagawa 2100852, Japan

Nippon Medical School Musashi Kosugi HospitalRecruiting

Kawasaki, Kanagawa 211-8533, Japan

Ina Central HospitalRecruiting

Ina, Nagano 396-0033, Japan

National Hospital Organization Niigata HospitalRecruiting

Kashiwazaki, Niigata 945-8585, Japan

Katayama Medical ClinicRecruiting

Kurashiki, Okayama-ken 710-0813, Japan

Tominaga ClinicRecruiting

Osaka, Osaka 5560015, Japan

National Hospital Organization Hizen Psychiatric CenterRecruiting

Yoshinogari-cho, Kanzaki-gun, Saga-ken 842-0192, Japan

Manabu Hashimoto, Site 0031Contact

0952523231

Local Institution - 0037Withdrawn

Wako, Saitama 351-0111, Japan

Wako HospitalRecruiting

Wako, Saitama 351-0111, Japan

Local Institution - 0107Not yet recruiting

Kyoto, 616-8255, Japan

Brain Research Center Den Bosch B.V.Recruiting

's-Hertogenbosch, North Brabant 5223 LA, Netherlands

Brain Research CenterRecruiting

Amsterdam, North Holland 1081 GN, Netherlands

Brain Research Center ZwolleRecruiting

Zwolle, Overijssel 8025 AZ, Netherlands

Instytut Zdrowia Dr Boczarska JedynakRecruiting

Oświęcim, Lesser Poland Voivodeship 32-600, Poland

Penta Hospitals Przychodnie, Wrocław WejherowskaRecruiting

Wroclaw, Lower Silesian Voivodeship 54-239, Poland

Local Institution - 0108Withdrawn

Lublin, Lublin Voivodeship 20-064, Poland

EMC Silesia sp. z o.o.Recruiting

Katowice, Silesian Voivodeship 40-353, Poland

Campus Neurológico SéniorRecruiting

Torres Vedras, Lisbon District 2560-280, Portugal

Unidade Local de Saude de MatosinhosRecruiting

Matosinhos Municipality, Porto District 4464-513, Portugal

Hospital de BragaRecruiting

Braga, 4710-243, Portugal

Unidade Local de Saúde de Coimbra, E.P.E.Recruiting

Coimbra, 3000 075, Portugal

Centro Hospitalar do Alto Ave - Hospital Senhora da OliveiraRecruiting

Guimarães, 4800-055, Portugal

Centro Hospitalar do Porto - Hospital de Santo AntónioRecruiting

Porto, 4050-014, Portugal

SCB Research CenterRecruiting

Bayamón, 00961, Puerto Rico

Prof. Dr. Alexandru Obregia Psychiatry HospitalRecruiting

Bucharest, Bucharest 041914, Romania

Prof. Dr. Alexandru Obregia Psychiatry HospitalRecruiting

Bucharest, Bucharest 041914, Romania

Local Institution - 0113Not yet recruiting

Constanța, Constanța County 900675, Romania

Local Institution - 0042Withdrawn

Bucharest, 0, Romania

Spitalul de Psihiatrie și Neurologie BrașovRecruiting

Sanpetru /Brasov, 507190, Romania

Petru Ifteni, Site 0041Contact

0040724993329

Fundació ACERecruiting

Barcelona, Barcelona [Barcelona] 08028, Spain

Policlinica GipuzkoaRecruiting

Donostia / San Sebastian, Basque Country 20014, Spain

Hospital Universitario Marqués de ValdecillaRecruiting

Santander, Cantabria 39008, Spain

Hospital Universitario Quironsalud MadridRecruiting

Pozuelo de Alarcón, Madrid 28223, Spain

Hospital Universitario Doctor PesetRecruiting

Valencia, Valenciana, Comunitat 46017, Spain

Complejo Hospitalario Ruber Juan BravoRecruiting

Madrid, 28006, Spain

Hospital Universitario 12 de OctubreRecruiting

Madrid, 28041, Spain

NIHR Manchester Clinical Research FacilityRecruiting

Manchester, England M13 9WL, United Kingdom

The Maudsley HospitalRecruiting

London, London, City of SE5 8AZ, United Kingdom

Local Institution - 0103Not yet recruiting

Edinburgh, Midlothian EH4 2XU, United Kingdom

Warneford HospitalRecruiting

Oxford, Oxfordshire OX3 7JX, United Kingdom

Re:Cognition Health - BirminghamRecruiting

Birmingham, B16 8LT, United Kingdom

Leeds and York Partnership NHS Foundation TrustRecruiting

Leeds, LS9 7TF, United Kingdom

NeuroClin GlasgowRecruiting

Motherwell, ML1 4UF, United Kingdom

Sheffield Teaching Hospitals NHS Foundation TrustRecruiting

Sheffield, S10 2JF, United Kingdom