A Study to Evaluate the Efficacy and Safety of KarXT + KarX-EC for Cognitive Impairment in Alzheimer's Disease | NCT06976216 | Trialant

A Study to Evaluate the Efficacy and Safety of KarXT + KarX-EC for Cognitive Impairment in Alzheimer's Disease | NCT06976216 | 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 reflect significant pathology other than AD or could affect safety or interfere with study procedures.

Other protocol-defined Inclusion/Exclusion criteria apply.

Healthy Brain ClinicRecruiting

Long Beach, California 90804, United States

Dung Trinh, Site 0173Contact

562-606-5999

Anderson Clinical ResearchRecruiting

Redlands, California 92374, United States

Mountain Neurological Research CenterRecruiting

Basalt, Colorado 81621, United States

Georgetown University Medical CenterRecruiting

Washington D.C., District of Columbia 20007, United States

JEM Research InstituteRecruiting

Atlantis, Florida 33462, United States

VIN-Julie SchwartzbardRecruiting

Aventura, Florida 33180, United States

Merritt Island Medical Research, LLCRecruiting

Merritt Island, Florida 32952, United States

Renstar Medical ResearchRecruiting

Ocala, Florida 34470, United States

Alzheimer's Research and Treatment CenterRecruiting

Stuart, Florida 34996, United States

Charter Research - Lady LakeRecruiting

The Villages, Florida 32162, United States

Local Institution - 0016Withdrawn

Columbus, Georgia 31909, United States

Center for Advanced Research & EducationRecruiting

Gainesville, Georgia 30501, United States

Re:Cognition Health - ChicagoRecruiting

Chicago, Illinois 60611, United States

Ascension Alexian BrothersRecruiting

Elk Grove Village, Illinois 60007, United States

Boston Center for MemoryRecruiting

Newton, Massachusetts 02459, United States

HealthPartners Neuroscience CenterRecruiting

Saint Paul, Minnesota 55130, United States

Advanced Memory Research Institute of New JerseyRecruiting

Toms River, New Jersey 08755, United States

NYU Langone HealthRecruiting

New York, New York 10016, United States

Local Institution - 0259Active, not recruiting

New York, New York 10029, United States

SUNY Upstate Medical UniversityRecruiting

Syracuse, New York 13210, United States

AMC Research, LLCRecruiting

Matthews, North Carolina 28105, United States

Ohio State UniversityRecruiting

Columbus, Ohio 43221, United States

NDx Clinical Research Inc.Recruiting

Dayton, Ohio 45459, United States

Summit HeadlandsRecruiting

Portland, Oregon 97210, United States

Local Institution - 0004Withdrawn

Abington, Pennsylvania 19001, United States

Rhode Island Mood & Memory Research InstituteRecruiting

East Providence, Rhode Island 02914, United States

Neurology Clinic, P.C.Recruiting

Cordova, Tennessee 38018, United States

Gadolin ResearchRecruiting

Beaumont, Texas 77702, United States

Fundación para el Estudio y Tratamiento de Enfermedades Mentales (FETEM)Recruiting

Buenos Aires, Buenos Aires F.D. 1133, Argentina

Local Institution - 0271Not yet recruiting

Buenos Aires, 1280, Argentina

Fundación Lennox - Instituto Modelo de NeurologíaRecruiting

Córdoba, 5000, Argentina

Sanatorio Morra S.A.Recruiting

Córdoba, 5000, Argentina

Instituto KremerRecruiting

Córdoba, X5004AOA, Argentina

Southern NeurologyRecruiting

Kogarah, New South Wales 2217, Australia

KARA Institute for Neurological DiseasesRecruiting

Macquarie Park, New South Wales 2113, Australia

NeuroCentrixRecruiting

Carlton, Victoria 3053, Australia

Neurodegenerative Disorders ResearchRecruiting

Perth, Western Australia 6005, Australia

St Vincent's Hospital Sydney LimitedRecruiting

Darlinghurst, 2010, Australia

Local Institution - 0168Not yet recruiting

Brasília, Federal District 70200730, Brazil

Instituto de Neurologia de CuritibaRecruiting

Curitiba, Paraná 81210310, Brazil

Local Institution - 0266Not yet recruiting

Aracaju, Sergipe 49075-000, Brazil

Hospital das Clinicas FMUSPRecruiting

São Paulo, 05403-000, Brazil

OCT Research ULCRecruiting

Kelowna, British Columbia V1Y 1Z9, Canada

Richmond Clinical TrialsRecruiting

Richmond, British Columbia V6V 2L1, Canada

Centricity Research Halifax MultispecialtyRecruiting

Halifax, Nova Scotia B3S 1N2, Canada

Ottawa Memory ClinicRecruiting

Ottawa, Ontario K1Z 1G3, Canada

Toronto Memory ProgramRecruiting

Toronto, Ontario M3B 2S7, Canada

MoCA Research and Innovation Inc.Recruiting

Greenfield Park, Quebec J4V 2J2, Canada

Diex Recherche VictoriavilleRecruiting

Victoriaville, Quebec G6P 3Z8, Canada

ALPHA Recherche CliniqueRecruiting

Québec, G3K 2P8, Canada

Local Institution - 0094Not yet recruiting

Santiago, Santiago Metropolitan 7500710, Chile

Local Institution - 0089Not yet recruiting

Santiago, Santiago Metropolitan 7560356, Chile

Local Institution - 0241Not yet recruiting

Santiago, Santiago Metropolitan 8380420, Chile

Local Institution - 0230Not yet recruiting

Antofagasta, 1270244, Chile

Local Institution - 0215Not yet recruiting

Zagreb, City of Zagreb 10000, Croatia

Poliklinika NeuronRecruiting

Zagreb, City of Zagreb 10000, Croatia

Klinika za psihijatriju "Vrapče"Recruiting

Zagreb, 10090, Croatia

Neuro Health CentrumRecruiting

Brno, Brno-město 628 00, Czechia

AGE CentrumRecruiting

Olomouc, Olomouc Region 779 00, Czechia

A-ShineRecruiting

Pilsen, Plzeň-město 301 00, Czechia

Neurologická Ambulance - ForbeliRecruiting

Prague, Praha 6 160 00, Czechia

NeuropsychiatrieRecruiting

Prague, Praha 6 160 00, Czechia

Local Institution - 0222Active, not recruiting

Prague, Praha 8 18600, Czechia

Vestra ClinicsRecruiting

Rychnov nad Kněžnou, 516 01, Czechia

Local Institution - 0295Not yet recruiting

Nice, Alpes-Maritimes 06100, France

Local Institution - 0289Not yet recruiting

Toulouse, Haute-Garonne 31000, France

Local Institution - 0290Not yet recruiting

Rouen, Haute-Normandie 76031, France

Local Institution - 0291Not yet recruiting

Montpellier, Languedoc-Roussillon 34295, France

Local Institution - 0299Not yet recruiting

Reims, Marne 51092, France

Local Institution - 0293Not yet recruiting

Villeurbanne, Rhône 69100, France

Local Institution - 0294Not yet recruiting

Dijon, 21079, France

Local Institution - 0301Not yet recruiting

Mannheim, Baden-Wurttemberg 68159, Germany

Universitätsklinikum Münster - Albert Schweitzer CampusRecruiting

Münster, North Rhine-Westphalia 48149, Germany

Universitätsmedizin Johannes Gutenberg Universität MainzRecruiting

Mainz, Rhineland-Palatinate 55131, Germany

Charite-Universitaetsmedizin Berlin - Campus Benjamin Franklin (CBF)Recruiting

Berlin, State of Berlin 12203, Germany

Local Institution - 0300Not yet recruiting

Aachen, 52074, Germany

Local Institution - 0302Not yet recruiting

Berlin, 12203, Germany

Local Institution - 0277Withdrawn

Bremen, 28325, Germany

Local Institution - 0275Withdrawn

Hamburg, 20246, Germany

TUM KlinikumRecruiting

Munich, 81675, Germany

University General Hospital of AlexandroupoliRecruiting

Alexandroupoli, Anatolikí Makedonía Kai Thráki 681 00, Greece

Local Institution - 0256Withdrawn

Athens, Attikí 115 25, Greece

Aiginiteio University HospitalRecruiting

Athens, Attikí 115 28, Greece

University General Hospital of LarissaRecruiting

Larissa, Thessalía 41110, Greece

Local Institution - 0288Not yet recruiting

Bengaluru, Karnataka 560029, India

Local Institution - 0282Not yet recruiting

Hyderabad, Telangana 500034, India

Local Institution - 0285Not yet recruiting

Hyderabad, Telangana 500082, India

Local Institution - 0287Not yet recruiting

Varanasi, Uttar Pradesh 221005, India

Local Institution - 0286Not yet recruiting

Kolkata, West Bengal 700054, India

Fondazione IRCCS Cà Granda Ospedale Maggiore PoliclinicoRecruiting

Milan, Lombardy 20122, Italy

Ospedale San RaffaeleRecruiting

Milan, Lombardy 20132, Italy

Fondazione IRCCS San Gerardo dei TintoriRecruiting

Monza, Lombardy 20900, Italy

Azienda Ospedaliera Spedali Civili di BresciaRecruiting

Brescia, 25123, Italy

Local Institution - 0296Not yet recruiting

's-Hertogenbosch, North Brabant 5223 LA, Netherlands

Local Institution - 0297Not yet recruiting

Amsterdam, North Holland 1081 GN, Netherlands

Local Institution - 0298Not yet recruiting

Zwolle, Overijssel 8025 AZ, Netherlands

Centrum Medyczne HCPRecruiting

Poznan, Greater Poland Voivodeship 61-485, Poland

Osrodek Badan Klinicznych CLINSANTE S.C.Recruiting

Torun, Kuyavian-Pomeranian Voivodeship 87-100, Poland

MlynowaMed PsychiatricRecruiting

Bialystok, Podlaskie Voivodeship 15-404, Poland

Penta Hospitals Badania Kliniczne - Gdańsk 1Recruiting

Gdansk, Pomeranian Voivodeship 80-546, Poland

Instituto De Neurologia Dra. Ivonne FragaRecruiting

San Juan, 00918, Puerto Rico

Prof. Dr. Alexandru Obregia Psychiatry HospitalRecruiting

Bucharest, Bucharest 041914, Romania

Prof. Dr. Alexandru Obregia Psychiatry HospitalRecruiting

Bucharest, Bucharest 041914, Romania

Institutul Național de Gerontologie și Geriatrie "Ana Aslan"Recruiting

Bucharest, 011241, Romania

Centrul de Sanatate MintalaRecruiting

Bucharest, 040874, Romania

Institutul de Psihiatrie SocolaRecruiting

Iași, 700282, Romania

Chonnam National University HospitalRecruiting

Gwangju, Kwangju-Kwangyǒkshi 61469, South Korea

Seoul National University Bundang HospitalRecruiting

Seongnam, Kyǒnggi-do 13620, South Korea

Seoul National University HospitalRecruiting

Seoul, Seoul-teukbyeolsi [Seoul] 03080, South Korea

Hanyang University Seoul HospitalRecruiting

Seoul, Seoul-teukbyeolsi [Seoul] 04763, South Korea

Konkuk University Medical CenterRecruiting

Seoul, Seoul-teukbyeolsi [Seoul] 05030, South Korea

Samsung Medical CenterRecruiting

Seoul, Seoul-teukbyeolsi [Seoul] 06351, South Korea

Ewha Womans University Seoul HospitalRecruiting

Seoul, Seoul-teukbyeolsi [Seoul] 07804, South Korea

Hospital Victoria EugeniaRecruiting

Seville, Andalusia 41009, Spain

Hospital Universitari General de CatalunyaRecruiting

Sant Cugat del Vallès, Barcelona [Barcelona] 08915, Spain

Hospital Clínic de BarcelonaRecruiting

Barcelona, Catalunya [Cataluña] 08036, Spain

Hospital Universitari de Santa MariaRecruiting

Lleida, Lleida [Lérida] 25198, Spain

Clinica Universidad de NavarraRecruiting

Pamplona, Navarre 31008, Spain

Hospital Clinico San CarlosRecruiting

Madrid, 28040, Spain