A Study to Evaluate the Efficacy and Safety of KarXT + KarX-EC for Cognitive Impairment…

Alzheimer's DiseaseCognitive functionBrain and nervesDrugPhase 3

What this study is

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

What's being tested

KarXT
Intervention · DRUG
KarX-EC
Intervention · DRUG
Placebo
Intervention · OTHER

All interventions

Specified dose on specified days

Study details

Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of KarXT + KarX-EC for the Treatment of Cognitive Impairment Associated With Mild to Moderate Alzheimer's Disease (MINDSET 1)
Sponsor: Bristol-Myers Squibb
Conditions: Alzheimer's Disease
Enrolling: 586 people
Starts: 2025-07-14
Est. completion: 2029-02-23
Design: Double-blind, randomized, parallel groups, Phase 3
Record: View on ClinicalTrials.gov ↗

Who can join

Age 60 Years – 85 YearsSex ALLHealthy volunteers Not accepted

You may qualify if

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.

You can't join if

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.

Study locations (119)

112 open

Healthy Brain Clinic
Long Beach, California, United States
- Dung Trinh, Site 0173 · Contact562-606-5999
Recruiting
Anderson Clinical Research
Redlands, California, United States
- Donald Anderson, Site 0008 · Contact909-792-9007
Recruiting
Mountain Neurological Research Center
Basalt, Colorado, United States
- Alison Allen, Site 0025 · Contact970-927-1141
Recruiting
Georgetown University Medical Center
Washington D.C., District of Columbia, United States
- Raymond Turner, Site 0024 · Contact202-687-7337
Recruiting
JEM Research Institute
Atlantis, Florida, United States
- Linda Pao, Site 0154 · Contact561-968-2933
Recruiting
VIN-Julie Schwartzbard
Aventura, Florida, United States
- Julie Schwartzbard, Site 0128 · Contact833-732-2484
Recruiting
Merritt Island Medical Research, LLC
Merritt Island, Florida, United States
- Wasim Niazi, Site 0023 · Contact386-785-8009
Recruiting
Renstar Medical Research
Ocala, Florida, United States
- Anette Nieves, Site 0055 · Contact352-629-5800
Recruiting
Alzheimer's Research and Treatment Center
Stuart, Florida, United States
- Adam Falchook, Site 0263 · Contact561-209-2400
Recruiting
Charter Research - Lady Lake
The Villages, Florida, United States
- Jeffrey Norton, Site 0184 · Contact352-775-1000
Recruiting
Center for Advanced Research & Education
Gainesville, Georgia, United States
- Angela Ritter, Site 0125 · Contact770-519-5254
Recruiting
Re:Cognition Health - Chicago
Chicago, Illinois, United States
- Antonio Iglesias, Site 0109 · Contact312-971-3318
Recruiting
Ascension Alexian Brothers
Elk Grove Village, Illinois, United States
- Concetta Forchetti, Site 0054 · Contact847-593-8553
Recruiting
Boston Center for Memory
Newton, Massachusetts, United States
- Paul Solomon, Site 0009 · Contact413-281-0577
Recruiting
HealthPartners Neuroscience Center
Saint Paul, Minnesota, United States
- Marcel Hungs, Site 0110 · Contact111-111-1111
Recruiting
Advanced Memory Research Institute of New Jersey
Toms River, New Jersey, United States
- Arun Singh, Site 0123 · Contact732-341-9500
Recruiting
NYU Langone Health
New York, New York, United States
- Martin Sadowski, Site 0101 · Contact212-263-5708
Recruiting
SUNY Upstate Medical University
Syracuse, New York, United States
- Andrea Berg, Site 0202 · Contact
Recruiting
Ohio State University
Columbus, Ohio, United States
- Douglas Scharre, Site 0073 · Contact
Recruiting
NDx Clinical Research Inc.
Dayton, Ohio, United States
- Joel Vandersluis, Site 0026 · Contact305-456-7782
Recruiting
Summit Headlands
Portland, Oregon, United States
- Scott Losk, Site 0067 · Contact503-279-8252
Recruiting
Rhode Island Mood & Memory Research Institute
East Providence, Rhode Island, United States
- john stoukides, Site 0056 · Contact401-435-8950
Recruiting
Neurology Clinic, P.C.
Cordova, Tennessee, United States
- Thomas Arnold, Site 0099 · Contact901-866-9252
Recruiting
Gadolin Research
Beaumont, Texas, United States
- Joseph Oommen, Site 0018 · Contact409-331-6040
Recruiting
Local Institution - 0016
Columbus, Georgia, United States
Withdrawn
Local Institution - 0259
New York, New York, United States
Active, not recruiting
Local Institution - 0007
Matthews, North Carolina, United States
Active, not recruiting
Local Institution - 0004
Abington, Pennsylvania, United States
Withdrawn

91 sites outside the US

Fundación para el Estudio y Tratamiento de Enfermedades Mentales (FETEM)
Buenos Aires, Buenos Aires F.D., Argentina
- Ricardo Corral, Site 0001 · Contact5491144455572
Recruiting
Local Institution - 0271
Buenos Aires, Argentina
- Site 0271 · Contact
Not yet recruiting
Fundación Lennox - Instituto Modelo de Neurología
Córdoba, Argentina
- Georgina Viczena, Site 0232 · Contact+5493515993881
Recruiting
Sanatorio Morra S.A.
Córdoba, Argentina
- Carlos Morra, Site 0228 · Contact+543514822191
Recruiting
Instituto Kremer
Córdoba, Argentina
- Leonardo Kremer, Site 0085 · Contact543515000000
Recruiting
Southern Neurology
Kogarah, New South Wales, Australia
- Colin Mahoney, Site 0279 · Contact+61 2 8566 1500
Recruiting
KARA Institute for Neurological Diseases
Macquarie Park, New South Wales, Australia
- Kathryn Goozee, Site 0245 · Contact61 2 8960 7788
Recruiting
NeuroCentrix
Carlton, Victoria, Australia
- David Barton, Site 0242 · Contact+61 3 9546 0009
Recruiting
Neurodegenerative Disorders Research
Perth, Western Australia, Australia
- Peter Panegyres, Site 0243 · Contact+61 8 6317 9472
Recruiting
St Vincent's Hospital Sydney Limited
Darlinghurst, Australia
- Bruce Brew, Site 0244 · Contact61 2 8382 4983
Recruiting
L2IP - Instituto de Pesquisas Clínicas
Brasília, Federal District, Brazil
- Eduardo Vasconcellos, Site 0168 · Contact55-6199983-1080
Recruiting
Instituto de Neurologia de Curitiba
Curitiba, Paraná, Brazil
- Pedro Kowacs, Site 0180 · Contact+5541999775432
Recruiting
Local Institution - 0266
Aracaju, Sergipe, Brazil
- Site 0266 · Contact
Not yet recruiting
Hospital das Clinicas FMUSP
São Paulo, Brazil
- Sonia Brucki, Site 0165 · Contact+5511996466593
Recruiting
OCT Research ULC
Kelowna, British Columbia, Canada
- Pieter Strauss, Site 0233 · Contact250-862-8141
Recruiting
Richmond Clinical Trials
Richmond, British Columbia, Canada
- Harris Lari, Site 0234 · Contact604-373-4954
Recruiting
Centricity Research Halifax Multispecialty
Halifax, Nova Scotia, Canada
- Kerrie Schoffer, Site 0236 · Contact902-609-6845 x7115
Recruiting
Ottawa Memory Clinic
Ottawa, Ontario, Canada
- Richard Bergeron, Site 0237 · Contact1-613-702-1000
Recruiting
Toronto Memory Program
Toronto, Ontario, Canada
- Manpreet Kaur, Site 0235 · Contact416-386-9606
Recruiting
MoCA Research and Innovation Inc.
Greenfield Park, Quebec, Canada
- Ziad Nasreddine, Site 0238 · Contact450-672-7766
Recruiting
Diex Recherche Victoriaville
Victoriaville, Quebec, Canada
- Ethel Bellavance, Site 0239 · Contact819-260-1172
Recruiting
ALPHA Recherche Clinique
Québec, Canada
- Claude Patry, Site 0264 · Contact418-847-1112
Recruiting
Local Institution - 0094
Santiago, Santiago Metropolitan, Chile
- Site 0094 · Contact
Not yet recruiting
Especialidades Médicas LYS
Santiago, Santiago Metropolitan, Chile
- Manuel Lavados, Site 0089 · Contact222016979
Recruiting
Local Institution - 0241
Santiago, Santiago Metropolitan, Chile
- Site 0241 · Contact
Not yet recruiting
Local Institution - 0230
Antofagasta, Chile
- Site 0230 · Contact
Not yet recruiting
Local Institution - 0215
Zagreb, City of Zagreb, Croatia
- Site 0215 · Contact
Not yet recruiting
Poliklinika Neuron
Zagreb, City of Zagreb, Croatia
- Neven Henigsberg, Site 0284 · Contact+38514596866
Recruiting
Klinika za psihijatriju "Vrapče"
Zagreb, Croatia
- Ninoslav Mimica, Site 0240 · Contact+38513780678
Recruiting
Neuro Health Centrum
Brno, Brno-město, Czechia
- Katerina Sheardova, Site 0227 · Contact+420603198029
Recruiting
AGE Centrum
Olomouc, Olomouc Region, Czechia
- Dagmar Malotova, Site 0225 · Contact00420723060809
Recruiting
A-Shine
Pilsen, Plzeň-město, Czechia
- Lubos Janu, Site 0221 · Contact420777242101
Recruiting
Neurologická Ambulance - Forbeli
Prague, Praha 6, Czechia
- Michal Bajacek, Site 0224 · Contact+420608164394
Recruiting
Neuropsychiatrie
Prague, Praha 6, Czechia
- Jakub Hort, Site 0223 · Contact+420224434700
Recruiting
Institut neuropsychiatricke pece (INEP), Praha
Prague, Praha 8, Czechia
- Alexander Nawka, Site 0222 · Contact+420605809745
Recruiting
Vestra Clinics
Rychnov nad Kněžnou, Czechia
- Ladislav Pazdera, Site 0226 · Contact420604236033
Recruiting
Local Institution - 0295
Nice, Alpes-Maritimes, France
- Site 0295 · Contact
Not yet recruiting
Local Institution - 0289
Toulouse, Haute-Garonne, France
- Site 0289 · Contact
Not yet recruiting
Local Institution - 0290
Rouen, Haute-Normandie, France
- Site 0290 · Contact
Not yet recruiting
Local Institution - 0291
Montpellier, Languedoc-Roussillon, France
- Site 0291 · Contact
Not yet recruiting
Local Institution - 0299
Reims, Marne, France
- Site 0299 · Contact
Not yet recruiting
Local Institution - 0293
Villeurbanne, Rhône, France
- Site 0293 · Contact
Not yet recruiting
Local Institution - 0294
Dijon, France
- Site 0294 · Contact
Not yet recruiting
Local Institution - 0301
Mannheim, Baden-Wurttemberg, Germany
- Site 0301 · Contact
Not yet recruiting
Universitätsklinikum Münster - Albert Schweitzer Campus
Münster, North Rhine-Westphalia, Germany
- Matthias Pawlowski, Site 0219 · Contact+492518348239
Recruiting
Universitätsmedizin Johannes Gutenberg Universität Mainz
Mainz, Rhineland-Palatinate, Germany
- Susanne Englisch, Site 0276 · Contact+49613117-2920
Recruiting
Charite-Universitaetsmedizin Berlin - Campus Benjamin Franklin (CBF)
Berlin, State of Berlin, Germany
- Julian Hellmann-Regen, Site 0218 · Contact+4930450517654
Recruiting
Local Institution - 0300
Aachen, Germany
- Site 0300 · Contact
Not yet recruiting
Local Institution - 0302
Berlin, Germany
- Site 0302 · Contact
Not yet recruiting
TUM Klinikum
Munich, Germany
- Timo Grimmer, Site 0217 · Contact+498941404262
Recruiting
University General Hospital of Alexandroupoli
Alexandroupoli, Anatolikí Makedonía Kai Thráki, Greece
- KONSTANTINOS VADIKOLIAS, Site 0281 · Contact+302551030351
Recruiting
Aiginiteio University Hospital
Athens, Attikí, Greece
- Nikolaos Scarmeas, Site 0274 · Contact
Recruiting
University General Hospital of Larissa
Larissa, Thessalía, Greece
- Efthimios Dardiotis, Site 0257 · Contact00306974224279
Recruiting
Local Institution - 0288
Bengaluru, Karnataka, India
- Site 0288 · Contact
Not yet recruiting
Local Institution - 0282
Hyderabad, Telangana, India
- Site 0282 · Contact
Not yet recruiting
Local Institution - 0285
Hyderabad, Telangana, India
- Site 0285 · Contact
Not yet recruiting
Local Institution - 0287
Varanasi, Uttar Pradesh, India
- Site 0287 · Contact
Not yet recruiting
Local Institution - 0286
Kolkata, West Bengal, India
- Site 0286 · Contact
Not yet recruiting
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Milan, Lombardy, Italy
- Andrea Arighi, Site 0249 · Contact+390255033842
Recruiting
Ospedale San Raffaele
Milan, Lombardy, Italy
- Massimo Filippi, Site 0246 · Contact+390226433958
Recruiting
Fondazione IRCCS San Gerardo dei Tintori
Monza, Lombardy, Italy
- Fulvio Da Re, Site 0248 · Contact0392332440
Recruiting
Azienda Ospedaliera Spedali Civili di Brescia
Brescia, Italy
- Salvatore Caratozzolo, Site 0247 · Contact+393930406304
Recruiting
Brain Research Center Den Bosch B.V.
's-Hertogenbosch, North Brabant, Netherlands
- Paul Dautzenberg, Site 0296 · Contact+31736996000
Recruiting
Local Institution - 0297
Amsterdam, North Holland, Netherlands
- Site 0297 · Contact
Not yet recruiting
Local Institution - 0298
Zwolle, Overijssel, Netherlands
- Site 0298 · Contact
Not yet recruiting
Centrum Medyczne HCP
Poznan, Greater Poland Voivodeship, Poland
- Przemyslaw Osip, Site 0262 · Contact+48604116632
Recruiting
Osrodek Badan Klinicznych CLINSANTE S.C.
Torun, Kuyavian-Pomeranian Voivodeship, Poland
- Marzena Maryniak-Wisniewska, Site 0261 · Contact+48601638933
Recruiting
MlynowaMed Psychiatric
Bialystok, Podlaskie Voivodeship, Poland
- Joanna Lazarczyk, Site 0280 · Contact0048792009929
Recruiting
Penta Hospitals Badania Kliniczne - Gdańsk 1
Gdansk, Pomeranian Voivodeship, Poland
- Katarzyna Binkowska-Michalik, Site 0260 · Contact+48587192222
Recruiting
Instituto De Neurologia Dra. Ivonne Fraga
San Juan, Puerto Rico
- Ivonne Fraga Berrios, Site 0181 · Contact(787)403-5534
Recruiting
Prof. Dr. Alexandru Obregia Psychiatry Hospital
Bucharest, Bucharest, Romania
- Laura Cristina Dolis, Site 0269 · Contact0040757243543
Recruiting
Prof. Dr. Alexandru Obregia Psychiatry Hospital
Bucharest, Bucharest, Romania
- Corina Nicolae, Site 0270 · Contact+40727818190
Recruiting
Institutul Național de Gerontologie și Geriatrie "Ana Aslan"
Bucharest, Romania
- Traian Purnichi, Site 0278 · Contact+40749156565
Recruiting
Centrul de Sanatate Mintala
Bucharest, Romania
- Mihaela Rosca, Site 0273 · Contact+40745588989
Recruiting
Institutul de Psihiatrie Socola
Iași, Romania
- CRISTINEL STEFANESCU, Site 0268 · Contact+40744518195
Recruiting
Chonnam National University Hospital
Gwangju, Kwangju-Kwangyǒkshi, South Korea
- Byeong Chae Kim, Site 0209 · Contact+821073107357
Recruiting
Seoul National University Bundang Hospital
Seongnam, Kyǒnggi-do, South Korea
- Ji Won Han, Site 0214 · Contact82-31-787-7438
Recruiting
Seoul National University Hospital
Seoul, Seoul-teukbyeolsi [Seoul], South Korea
- Manho Kim, Site 0213 · Contact+82-2-2072-2193
Recruiting
Hanyang University Seoul Hospital
Seoul, Seoul-teukbyeolsi [Seoul], South Korea
- Hee-Jin Kim, Site 0208 · Contact+82-10-7118-2292
Recruiting
Konkuk University Medical Center
Seoul, Seoul-teukbyeolsi [Seoul], South Korea
- Seol-Heui Han, Site 0210 · Contact+821045057561
Recruiting
Samsung Medical Center
Seoul, Seoul-teukbyeolsi [Seoul], South Korea
- Sang Won Seo, Site 0212 · Contact+82-2-3410-1233
Recruiting
Ewha Womans University Seoul Hospital
Seoul, Seoul-teukbyeolsi [Seoul], South Korea
- Jee Hyang Jeong, Site 0211 · Contact+821090851927
Recruiting
Hospital Victoria Eugenia
Seville, Andalusia, Spain
- Felix Vinuela Fernandez, Site 0255 · Contact+34654566812
Recruiting
Hospital Universitari General de Catalunya
Sant Cugat del Vallès, Barcelona [Barcelona], Spain
- Ernest Balaguer, Site 0254 · Contact0034651891344
Recruiting
Hospital Clínic de Barcelona
Barcelona, Catalunya [Cataluña], Spain
- Albert Llado Plarrumani, Site 0258 · Contact+34 934 518 240
Recruiting
Hospital Universitari de Santa Maria
Lleida, Lleida [Lérida], Spain
- Gerard Piñol, Site 0253 · Contact696146758
Recruiting
Clinica Universidad de Navarra
Pamplona, Navarre, Spain
- Mario Riverol Fernández, Site 0252 · Contact+34653103158
Recruiting
Hospital Clinico San Carlos
Madrid, Spain
- JORDI MATIAS-GUIU ANTEM, Site 0250 · Contact+34676933312
Recruiting
Local Institution - 0277
Bremen, Germany
Withdrawn
Local Institution - 0275
Hamburg, Germany
Withdrawn
Local Institution - 0256
Athens, Attikí, Greece
Withdrawn

KarXT with KarX-EC for cognitive impairment in mild to moderate Alzheimer's disease

What this study is

What's being tested

Study details

Who can join

Monitoring & Endpoints

Study locations (119)

Study team

Bristol-Myers Squibb

Bristol-Myers Squibb

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

First line of the email MUST contain NCT # and Site #.

Frequently asked questions