Alzheimer's DiseasePhase 3MINDSET 1NCT06976216
A Study to Evaluate the Efficacy and Safety of KarXT + KarX-EC for Cognitive Impairment in Alzheimer's Disease
A Phase 3 study testing KarXT and KarX-EC in people with Alzheimer's Disease, run by Bristol-Myers Squibb at 119 sites in 19 countries.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of KarXT + KarX-EC for cognitive impairment in Alzheimer's Disease Read more about this study
- Who is it for?
- Ages 60 to 85 years
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- KarXT and KarX-EC
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 586 participants
- Where
- 119 sitesin 19 countries
- Study dates
- 14 Jul 2025to 23 Feb 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
119 sites in 19 countries. Contact the study team or a site near you to ask about taking part.
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com contact
First line of the email MUST contain NCT # and Site #. contact
119 sites in 19 countries
United States28 sites, 24 recruiting
- Withdrawn
Local Institution - 0004
Abington, Pennsylvania, 19001
- Recruiting
JEM Research Institute
Atlantis, Florida, 33462
Linda Pao, Site 0154, 561-968-2933
- Recruiting
VIN-Julie Schwartzbard
Aventura, Florida, 33180
Julie Schwartzbard, Site 0128, 833-732-2484
- Recruiting
Mountain Neurological Research Center
Basalt, Colorado, 81621
Alison Allen, Site 0025, 970-927-1141
- Recruiting
Gadolin Research
Beaumont, Texas, 77702
Joseph Oommen, Site 0018, 409-331-6040
- Recruiting
Re:Cognition Health - Chicago
Chicago, Illinois, 60611
Antonio Iglesias, Site 0109, 312-971-3318
- Withdrawn
Local Institution - 0016
Columbus, Georgia, 31909
- Recruiting
Ohio State University
Columbus, Ohio, 43221
Douglas Scharre, Site 0073
- Recruiting
Neurology Clinic, P.C.
Cordova, Tennessee, 38018
Thomas Arnold, Site 0099, 901-866-9252
- Recruiting
NDx Clinical Research Inc.
Dayton, Ohio, 45459
Joel Vandersluis, Site 0026, 305-456-7782
- Recruiting
Rhode Island Mood & Memory Research Institute
East Providence, Rhode Island, 02914
john stoukides, Site 0056, 401-435-8950
- Recruiting
Ascension Alexian Brothers
Elk Grove Village, Illinois, 60007
Concetta Forchetti, Site 0054, 847-593-8553
- Recruiting
Center for Advanced Research & Education
Gainesville, Georgia, 30501
Angela Ritter, Site 0125, 770-519-5254
- Recruiting
Healthy Brain Clinic
Long Beach, California, 90804
Dung Trinh, Site 0173, 562-606-5999
- Active, not recruiting
Local Institution - 0007
Matthews, North Carolina, 28105
- Recruiting
Merritt Island Medical Research, LLC
Merritt Island, Florida, 32952
Wasim Niazi, Site 0023, 386-785-8009
- Recruiting
NYU Langone Health
New York, New York, 10016
Martin Sadowski, Site 0101, 212-263-5708
- Active, not recruiting
Local Institution - 0259
New York, New York, 10029
- Recruiting
Boston Center for Memory
Newton, Massachusetts, 02459
Paul Solomon, Site 0009, 413-281-0577
- Recruiting
Renstar Medical Research
Ocala, Florida, 34470
Anette Nieves, Site 0055, 352-629-5800
- Recruiting
Summit Headlands
Portland, Oregon, 97210
Scott Losk, Site 0067, 503-279-8252
- Recruiting
Anderson Clinical Research
Redlands, California, 92374
Donald Anderson, Site 0008, 909-792-9007
- Recruiting
HealthPartners Neuroscience Center
Saint Paul, Minnesota, 55130
Marcel Hungs, Site 0110, 111-111-1111
- Recruiting
Alzheimer's Research and Treatment Center
Stuart, Florida, 34996
Adam Falchook, Site 0263, 561-209-2400
- Recruiting
SUNY Upstate Medical University
Syracuse, New York, 13210
Andrea Berg, Site 0202
- Recruiting
Charter Research - Lady Lake
The Villages, Florida, 32162
Jeffrey Norton, Site 0184, 352-775-1000
- Recruiting
Advanced Memory Research Institute of New Jersey
Toms River, New Jersey, 08755
Arun Singh, Site 0123, 732-341-9500
- Recruiting
Georgetown University Medical Center
Washington D.C., District of Columbia, 20007
Raymond Turner, Site 0024, 202-687-7337
Germany9 sites, 7 recruiting
- Not yet recruiting
Local Institution - 0300
Aachen, 52074
Site 0300
- Recruiting
Charite-Universitaetsmedizin Berlin - Campus Benjamin Franklin (CBF)
Berlin, State of Berlin, 12203
Julian Hellmann-Regen, Site 0218, +4930450517654
- Not yet recruiting
Local Institution - 0302
Berlin, 12203
Site 0302
- Withdrawn
Local Institution - 0277
Bremen, 28325
- Withdrawn
Local Institution - 0275
Hamburg, 20246
- Recruiting
Universitätsmedizin Johannes Gutenberg Universität Mainz
Mainz, Rhineland-Palatinate, 55131
Susanne Englisch, Site 0276, +49613117-2920
- Not yet recruiting
Local Institution - 0301
Mannheim, Baden-Wurttemberg, 68159
Site 0301
- Recruiting
TUM Klinikum
Munich, 81675
Timo Grimmer, Site 0217, +498941404262
- Recruiting
Universitätsklinikum Münster - Albert Schweitzer Campus
Münster, North Rhine-Westphalia, 48149
Matthias Pawlowski, Site 0219, +492518348239
Canada8 sites, 8 recruiting
- Recruiting
MoCA Research and Innovation Inc.
Greenfield Park, Quebec, J4V 2J2
Ziad Nasreddine, Site 0238, 450-672-7766
- Recruiting
Centricity Research Halifax Multispecialty
Halifax, Nova Scotia, B3S 1N2
Kerrie Schoffer, Site 0236, 902-609-6845 x7115
- Recruiting
OCT Research ULC
Kelowna, British Columbia, V1Y 1Z9
Pieter Strauss, Site 0233, 250-862-8141
- Recruiting
Ottawa Memory Clinic
Ottawa, Ontario, K1Z 1G3
Richard Bergeron, Site 0237, 1-613-702-1000
- Recruiting
ALPHA Recherche Clinique
Québec, G3K 2P8
Claude Patry, Site 0264, 418-847-1112
- Recruiting
Richmond Clinical Trials
Richmond, British Columbia, V6V 2L1
Harris Lari, Site 0234, 604-373-4954
- Recruiting
Toronto Memory Program
Toronto, Ontario, M3B 2S7
Manpreet Kaur, Site 0235, 416-386-9606
- Recruiting
Diex Recherche Victoriaville
Victoriaville, Quebec, G6P 3Z8
Ethel Bellavance, Site 0239, 819-260-1172
Czechia7 sites, 7 recruiting
- Recruiting
Neuro Health Centrum
Brno, Brno-město, 628 00
Katerina Sheardova, Site 0227, +420603198029
- Recruiting
AGE Centrum
Olomouc, Olomouc Region, 779 00
Dagmar Malotova, Site 0225, 00420723060809
- Recruiting
A-Shine
Pilsen, Plzeň-město, 301 00
Lubos Janu, Site 0221, 420777242101
- Recruiting
Neurologická Ambulance - Forbeli
Prague, Praha 6, 160 00
Michal Bajacek, Site 0224, +420608164394
- Recruiting
Neuropsychiatrie
Prague, Praha 6, 160 00
Jakub Hort, Site 0223, +420224434700
- Recruiting
Institut neuropsychiatricke pece (INEP), Praha
Prague, Praha 8, 18600
Alexander Nawka, Site 0222, +420605809745
- Recruiting
Vestra Clinics
Rychnov nad Kněžnou, 516 01
Ladislav Pazdera, Site 0226, 420604236033
France7 sites, 7 recruiting
- Not yet recruiting
Local Institution - 0294
Dijon, 21079
Site 0294
- Not yet recruiting
Local Institution - 0291
Montpellier, Languedoc-Roussillon, 34295
Site 0291
- Not yet recruiting
Local Institution - 0295
Nice, Alpes-Maritimes, 06100
Site 0295
- Not yet recruiting
Local Institution - 0299
Reims, Marne, 51092
Site 0299
- Not yet recruiting
Local Institution - 0290
Rouen, Haute-Normandie, 76031
Site 0290
- Not yet recruiting
Local Institution - 0289
Toulouse, Haute-Garonne, 31000
Site 0289
- Not yet recruiting
Local Institution - 0293
Villeurbanne, Rhône, 69100
Site 0293
South Korea7 sites, 7 recruiting
- Recruiting
Chonnam National University Hospital
Gwangju, Kwangju-Kwangyǒkshi, 61469
Byeong Chae Kim, Site 0209, +821073107357
- Recruiting
Seoul National University Bundang Hospital
Seongnam, Kyǒnggi-do, 13620
Ji Won Han, Site 0214, 82-31-787-7438
- Recruiting
Seoul National University Hospital
Seoul, Seoul-teukbyeolsi [Seoul], 03080
Manho Kim, Site 0213, +82-2-2072-2193
- Recruiting
Hanyang University Seoul Hospital
Seoul, Seoul-teukbyeolsi [Seoul], 04763
Hee-Jin Kim, Site 0208, +82-10-7118-2292
- Recruiting
Konkuk University Medical Center
Seoul, Seoul-teukbyeolsi [Seoul], 05030
Seol-Heui Han, Site 0210, +821045057561
- Recruiting
Samsung Medical Center
Seoul, Seoul-teukbyeolsi [Seoul], 06351
Sang Won Seo, Site 0212, +82-2-3410-1233
- Recruiting
Ewha Womans University Seoul Hospital
Seoul, Seoul-teukbyeolsi [Seoul], 07804
Jee Hyang Jeong, Site 0211, +821090851927
Spain6 sites, 6 recruiting
- Recruiting
Hospital Clínic de Barcelona
Barcelona, Catalunya [Cataluña], 08036
Albert Llado Plarrumani, Site 0258, +34 934 518 240
- Recruiting
Hospital Universitari de Santa Maria
Lleida, Lleida [Lérida], 25198
Gerard Piñol, Site 0253, 696146758
- Recruiting
Hospital Clinico San Carlos
Madrid, 28040
JORDI MATIAS-GUIU ANTEM, Site 0250, +34676933312
- Recruiting
Clinica Universidad de Navarra
Pamplona, Navarre, 31008
Mario Riverol Fernández, Site 0252, +34653103158
- Recruiting
Hospital Universitari General de Catalunya
Sant Cugat del Vallès, Barcelona [Barcelona], 08915
Ernest Balaguer, Site 0254, 0034651891344
- Recruiting
Hospital Victoria Eugenia
Seville, Andalusia, 41009
Felix Vinuela Fernandez, Site 0255, +34654566812
Argentina5 sites, 5 recruiting
- Recruiting
Fundación para el Estudio y Tratamiento de Enfermedades Mentales (FETEM)
Buenos Aires, Buenos Aires F.D., 1133
Ricardo Corral, Site 0001, 5491144455572
- Not yet recruiting
Local Institution - 0271
Buenos Aires, 1280
Site 0271
- Recruiting
Fundación Lennox - Instituto Modelo de Neurología
Córdoba, 5000
Georgina Viczena, Site 0232, +5493515993881
- Recruiting
Sanatorio Morra S.A.
Córdoba, 5000
Carlos Morra, Site 0228, +543514822191
- Recruiting
Instituto Kremer
Córdoba, X5004AOA
Leonardo Kremer, Site 0085, 543515000000
Australia5 sites, 5 recruiting
- Recruiting
NeuroCentrix
Carlton, Victoria, 3053
David Barton, Site 0242, +61 3 9546 0009
- Recruiting
St Vincent's Hospital Sydney Limited
Darlinghurst, 2010
Bruce Brew, Site 0244, 61 2 8382 4983
- Recruiting
Southern Neurology
Kogarah, New South Wales, 2217
Colin Mahoney, Site 0279, +61 2 8566 1500
- Recruiting
KARA Institute for Neurological Diseases
Macquarie Park, New South Wales, 2113
Kathryn Goozee, Site 0245, 61 2 8960 7788
- Recruiting
Neurodegenerative Disorders Research
Perth, Western Australia, 6005
Peter Panegyres, Site 0243, +61 8 6317 9472
India5 sites, 5 recruiting
- Not yet recruiting
Local Institution - 0288
Bengaluru, Karnataka, 560029
Site 0288
- Not yet recruiting
Local Institution - 0282
Hyderabad, Telangana, 500034
Site 0282
- Not yet recruiting
Local Institution - 0285
Hyderabad, Telangana, 500082
Site 0285
- Not yet recruiting
Local Institution - 0286
Kolkata, West Bengal, 700054
Site 0286
- Not yet recruiting
Local Institution - 0287
Varanasi, Uttar Pradesh, 221005
Site 0287
Romania5 sites, 5 recruiting
- Recruiting
Prof. Dr. Alexandru Obregia Psychiatry Hospital
Bucharest, Bucharest, 041914
Laura Cristina Dolis, Site 0269, 0040757243543
- Recruiting
Prof. Dr. Alexandru Obregia Psychiatry Hospital
Bucharest, Bucharest, 041914
Corina Nicolae, Site 0270, +40727818190
- Recruiting
Institutul Național de Gerontologie și Geriatrie "Ana Aslan"
Bucharest, 011241
Traian Purnichi, Site 0278, +40749156565
- Recruiting
Centrul de Sanatate Mintala
Bucharest, 040874
Mihaela Rosca, Site 0273, +40745588989
- Recruiting
Institutul de Psihiatrie Socola
Iași, 700282
CRISTINEL STEFANESCU, Site 0268, +40744518195
Brazil4 sites, 4 recruiting
- Not yet recruiting
Local Institution - 0266
Aracaju, Sergipe, 49075-000
Site 0266
- Recruiting
L2IP - Instituto de Pesquisas Clínicas
Brasília, Federal District, 70200730
Eduardo Vasconcellos, Site 0168, 55-6199983-1080
- Recruiting
Instituto de Neurologia de Curitiba
Curitiba, Paraná, 81210310
Pedro Kowacs, Site 0180, +5541999775432
- Recruiting
Hospital das Clinicas FMUSP
São Paulo, 05403-000
Sonia Brucki, Site 0165, +5511996466593
Chile4 sites, 4 recruiting
- Not yet recruiting
Local Institution - 0230
Antofagasta, 1270244
Site 0230
- Not yet recruiting
Local Institution - 0094
Santiago, Santiago Metropolitan, 7500710
Site 0094
- Recruiting
Especialidades Médicas LYS
Santiago, Santiago Metropolitan, 7560356
Manuel Lavados, Site 0089, 222016979
- Not yet recruiting
Local Institution - 0241
Santiago, Santiago Metropolitan, 8380420
Site 0241
Greece4 sites, 3 recruiting
- Recruiting
University General Hospital of Alexandroupoli
Alexandroupoli, Anatolikí Makedonía Kai Thráki, 681 00
KONSTANTINOS VADIKOLIAS, Site 0281, +302551030351
- Withdrawn
Local Institution - 0256
Athens, Attikí, 115 25
- Recruiting
Aiginiteio University Hospital
Athens, Attikí, 115 28
Nikolaos Scarmeas, Site 0274
- Recruiting
University General Hospital of Larissa
Larissa, Thessalía, 41110
Efthimios Dardiotis, Site 0257, 00306974224279
Italy4 sites, 4 recruiting
- Recruiting
Azienda Ospedaliera Spedali Civili di Brescia
Brescia, 25123
Salvatore Caratozzolo, Site 0247, +393930406304
- Recruiting
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Milan, Lombardy, 20122
Andrea Arighi, Site 0249, +390255033842
- Recruiting
Ospedale San Raffaele
Milan, Lombardy, 20132
Massimo Filippi, Site 0246, +390226433958
- Recruiting
Fondazione IRCCS San Gerardo dei Tintori
Monza, Lombardy, 20900
Fulvio Da Re, Site 0248, 0392332440
Poland4 sites, 4 recruiting
- Recruiting
MlynowaMed Psychiatric
Bialystok, Podlaskie Voivodeship, 15-404
Joanna Lazarczyk, Site 0280, 0048792009929
- Recruiting
Penta Hospitals Badania Kliniczne - Gdańsk 1
Gdansk, Pomeranian Voivodeship, 80-546
Katarzyna Binkowska-Michalik, Site 0260, +48587192222
- Recruiting
Centrum Medyczne HCP
Poznan, Greater Poland Voivodeship, 61-485
Przemyslaw Osip, Site 0262, +48604116632
- Recruiting
Osrodek Badan Klinicznych CLINSANTE S.C.
Torun, Kuyavian-Pomeranian Voivodeship, 87-100
Marzena Maryniak-Wisniewska, Site 0261, +48601638933
Croatia3 sites, 3 recruiting
- Not yet recruiting
Local Institution - 0215
Zagreb, City of Zagreb, 10000
Site 0215
- Recruiting
Poliklinika Neuron
Zagreb, City of Zagreb, 10000
Neven Henigsberg, Site 0284, +38514596866
- Recruiting
Klinika za psihijatriju "Vrapče"
Zagreb, 10090
Ninoslav Mimica, Site 0240, +38513780678
Netherlands3 sites, 3 recruiting
- Recruiting
Brain Research Center Den Bosch B.V.
's-Hertogenbosch, North Brabant, 5223 LA
Paul Dautzenberg, Site 0296, +31736996000
- Not yet recruiting
Local Institution - 0297
Amsterdam, North Holland, 1081 GN
Site 0297
- Not yet recruiting
Local Institution - 0298
Zwolle, Overijssel, 8025 AZ
Site 0298
Puerto Rico1 site, 1 recruiting
- Recruiting
Instituto De Neurologia Dra. Ivonne Fraga
San Juan, 00918
Ivonne Fraga Berrios, Site 0181, (787)403-5534
About this study
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)
The purpose of this study is to evaluate the efficacy and safety of KarXT + KarX-EC for cognitive impairment in Alzheimer's Disease
- Conditions
- Alzheimer's Disease
- Being tested
- KarXT, KarX-EC, Placebo
- Keywords
- Dementia, Cognitive Impairment, Kar-XT, KarX-EC, Mild Alzheimer's Disease, Moderate Alzheimer's Disease
- Medical subject headings
- Alzheimer Disease, Dementia, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KarXTDrug
Also called BMS-986510
Specified dose on specified days
KarX-ECDrug
Also called BMS-986519
Specified dose on specified days
PlaceboOther
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| KarXT + KarX-EC | Active comparator | Not described Receives: Drug: KarXT; Drug: KarX-EC |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale 11 (ADAS-Cog11)
Measured: At week 24
Clinician's Interview-Based Impression Plus Caregiver Input (CIBIC+)
Measured: At week 24
Secondary outcomes (13)
Change from baseline in Alzheimer's Disease Cooperative Study-Activities of Daily Living scale (ADCS-ADL)
Measured: At week 24
Change from baseline in neuro psychiatric inventory (NPI) total score
Measured: At week 24
Number of participants with adverse events (AEs)
Measured: At week 24
Number of participants with serious adverse events (SAEs)
Measured: At week 24
Number of participants with adverse event of special interest (AESIs)
Measured: At week 24
Number of participants with AEs leading to study intervention discontinuation
Measured: At week 24
Number of participants with AEs leading to study discontinuation
Measured: At week 24
Number of participants with AEs leading to death
Measured: At week 24
Number of participants with clinically significant changes in vital signs
Measured: At week 24
Number of participants with clinically significant changes in electrocardiogram (ECG) tests
Measured: At week 24
Number of participants with clinically significant changes in Columbia-Suicide Severity Rating Scale (C-SSRS) tests
Measured: At week 24
Number of participants with clinically significant changes in weight
Measured: At week 24
Number of participants with clinically significant changes in safety laboratory tests
Measured: At week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2025
- Study start14 Jul 2025
- Primary completion11 Sep 2028 (estimated)
- Study completion23 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 586 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06976216
- Sponsor's protocol ID
- CN012-0051
- Other IDs
- 2025-520746-30, U1111-1317-4462, 2025
- Acronym
- MINDSET 1
- Status last verified
- Oct 2026
- First submitted
- 9 May 2025
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT06976216
- Acronym / sponsor ID
- MINDSET 1 / CN012-0051
- Conditions
- Alzheimer's Disease
- Keywords
- Dementia, Cognitive Impairment, Kar-XT, KarX-EC, Mild Alzheimer's Disease, Moderate Alzheimer's Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 586 participants (estimated)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 14 Jul 2025 (actual)
- Primary completion
- 11 Sep 2028 (estimated)
- Study completion
- 23 Feb 2029 (estimated)
- First posted
- 16 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the efficacy and safety of KarXT + KarX-EC for cognitive impairment in Alzheimer's Disease
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| KarXT + KarX-EC | Active comparator | Drug: KarXT, Drug: KarX-EC |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KarXTAlso: BMS-986510Specified dose on specified days | Drug | KarXT + KarX-EC |
| KarX-ECAlso: BMS-986519Specified dose on specified days | Drug | KarXT + KarX-EC |
| PlaceboSpecified dose on specified days | Other | Placebo |
Primary outcome
Change from baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale 11 (ADAS-Cog11)
Time frame: At week 24
Clinician's Interview-Based Impression Plus Caregiver Input (CIBIC+)
Time frame: At week 24
13 secondary outcomes
Change from baseline in Alzheimer's Disease Cooperative Study-Activities of Daily Living scale (ADCS-ADL)
Time frame: At week 24
Change from baseline in neuro psychiatric inventory (NPI) total score
Time frame: At week 24
Number of participants with adverse events (AEs)
Time frame: At week 24
Number of participants with serious adverse events (SAEs)
Time frame: At week 24
Number of participants with adverse event of special interest (AESIs)
Time frame: At week 24
Number of participants with AEs leading to study intervention discontinuation
Time frame: At week 24
Number of participants with AEs leading to study discontinuation
Time frame: At week 24
Number of participants with AEs leading to death
Time frame: At week 24
Number of participants with clinically significant changes in vital signs
Time frame: At week 24
Number of participants with clinically significant changes in electrocardiogram (ECG) tests
Time frame: At week 24
Number of participants with clinically significant changes in Columbia-Suicide Severity Rating Scale (C-SSRS) tests
Time frame: At week 24
Number of participants with clinically significant changes in weight
Time frame: At week 24
Number of participants with clinically significant changes in safety laboratory tests
Time frame: At week 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com contact
First line of the email MUST contain NCT # and Site #. contact
Bristol-Myers Squibb study director
Bristol-Myers Squibb
119 sites in 19 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing KarXT and KarX-EC in people with Alzheimer's Disease, run by Bristol-Myers Squibb at 119 sites in 19 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 119 sites in United States, Germany, Canada, Czechia, France and 14 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact BMS Clinical Trials Contact Center www.BMSClinicalTrials.com (855-907-3286, Clinical.Trials@bms.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale 11 (ADAS-Cog11) (time frame: At week 24). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.