Alzheimer's DiseasePhase 3MINDSET 2NCT06976203
A Study to Evaluate the Efficacy and Safety of KarXT + KarX-EC for Cognitive Impairment in Alzheimer's Disease (MINDSET 2)
A Phase 3 study testing KarXT and KarX-EC in people with Alzheimer's Disease, run by Bristol-Myers Squibb at 128 sites in 17 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
- 128 sitesin 17 countries
- Study dates
- 21 Jul 2025to 23 Feb 2029
- Phase
- Phase 3
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 could affect safety or interfere with study procedures.
- Other protocol-defined Inclusion/Exclusion criteria apply.
Trial locations and contacts
128 sites in 17 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
128 sites in 17 countries
United States31 sites, 26 recruiting
- Recruiting
Neurological Associates Albany
Albany, New York, 12208
Richard Holub, Site 0077, 518-426-0575
- Recruiting
Dent Neurosciences Research Center, Inc
Amherst, New York, 14226
Horacio Capote, Site 0068, 716-250-2000
- Recruiting
University at Buffalo - UBMD Neurology
Buffalo, New York, 14203
Kinga Szigeti, Site 0087, 281-630-2316
- Recruiting
Great Lakes Clinical Trials - Andersonville
Chicago, Illinois, 60640
Jeffrey Ross, Site 0093, 847-252-7300
- Recruiting
Research of the Rockies
Colorado Springs, Colorado, 80919
Adam Wolff, Site 0088, 303-715-9024
- Not yet recruiting
Local Institution - 0081
Dallas, Texas, 75231
Site 0081
- Recruiting
QUEST Research Institute
Farmington Hills, Michigan, 48334
Aaron Ellenbogen, Site 0073, 248-957-8940
- Recruiting
Neuropsychiatric Research Center of Southwest Florida
Fort Myers, Florida, 33912
Jennifer Springer, Site 0090, 239-939-7777
- Recruiting
Fullerton Neurology and Headache Center
Fullerton, California, 92835
Jack Florin, Site 0072, 714-381-0801
- Completed
Local Institution - 0086
Hallandale, Florida, 33009
- Recruiting
Private Practice - Dr. Ronald Louis Schwartz
Hattiesburg, Mississippi, 39401
Ronald Schwartz, Site 0085, 601-606-0911
- Recruiting
Josephson Wallack Munshower Neurology, PC
Indianapolis, Indiana, 46256
Kristi George, Site 0071, 317-537-6088
- Recruiting
Irvine Clinical Research
Irvine, California, 92614
Elly Lee, Site 0095, 949-753-1663
- Recruiting
Jacksonville Center for Clinical Research
Jacksonville, Florida, 32216
Steven Toenjes, Site 0092, 904-673-1252
- Recruiting
K2 MEDICAL Research THE VILLAGES
Lady Lake, Florida, 32159
Craig Curtis, Site 0114, 407-426-9299
- Withdrawn
Local Institution - 0078
Lake Success, New York, 11042
- Recruiting
Inglewood Clinical
Los Angeles, California, 90056
Edward Zamrini, Site 0091, 706-863-9595
- Recruiting
Stanford Neuroscience Health Center
Palo Alto, California, 94304
Sharon Sha, Site 0083, 000-000-0000
- Recruiting
Keystone Clinical Studies
Plymouth Meeting, Pennsylvania, 19462
Cameron Olezene, Site 0105, 610-277-8073
- Completed
Local Institution - 0076
Renton, Washington, 98057
- Withdrawn
Local Institution - 0119
Ridgewood, New Jersey, 07450
- Recruiting
Central Texas Neurology Consultants, PA
Round Rock, Texas, 78681
Elizabeth Peckham, Site 0079, 443-852-2085
- Withdrawn
Local Institution - 0069
San Diego, California, 92103
- Recruiting
Intercoastal Medical Group
Sarasota, Florida, 34239
Mauricio Concha, Site 0082, 941-203-3750
- Recruiting
Southern Illinois University School of Medicine
Springfield, Illinois, 62702
Jennifer Arnold, Site 0070, 217-545-7197
- Recruiting
The Cognitive and Research Center of New Jersey
Springfield, New Jersey, 07081
Raminder Parihar, Site 0094, 973-850-4622
- Recruiting
USF Health Byrd Alzheimer's Institute
Tampa, Florida, 33613
Amanda Smith, Site 0084, 813-974-4355
- Not yet recruiting
Local Institution - 0129
The Villages, Florida, 32162
Site 0129
- Not yet recruiting
Local Institution - 0080
Watertown, Massachusetts, 02472
Site 0080
- Recruiting
Alzheimer's Research and Treatment Center
Wellington, Florida, 33414
David Watson, Site 0089, 561-209-2400
- Recruiting
Advanced Clinical Institute
West Long Branch, New Jersey, 07764
Mark Ornstein, Site 0075, 732-807-4700
Japan16 sites, 14 recruiting
- Not yet recruiting
Local Institution - 0131
Hirakata, Osaka, 573-1121
Site 0131
- Recruiting
Imon Yukari Neurology Clinic
Hiroshima, Hiroshima, 732-0066
Yukari Imon, Site 0124
- Recruiting
Ina Central Hospital
Ina, Nagano, 396-0033
Yusaku Shimizu, Site 0038
- Recruiting
Inage Neurology and Memory Clinic
Inage, Chiba, 263-0043
Yasumasa Yoshiyama, Site 0121, +81-43-307-8500
- Not yet recruiting
Local Institution - 0125
Kamakura, Kanagawa, 247-8533
Site 0125
- Recruiting
National Hospital Organization Niigata Hospital
Kashiwazaki, Niigata, 945-8585
Takashi Nakajima, Site 0033, +81-80-3494-7498
- Recruiting
Kokankai Kokan Clinic
Kawasaki, Kanagawa, 2100852
Yasuhiro Yoshii, Site 0122, 81443668900
- Recruiting
Nippon Medical School Musashi Kosugi Hospital
Kawasaki, Kanagawa, 211-8533
Kentaro Suzuki, Site 0106, 819049382816
- Recruiting
Kagawa University Hospital
Kita-gun, Kagawa-ken, 761-0793
Ichiro Ishikawa, Site 0120, 81878912345
- Recruiting
Katayama Medical Clinic
Kurashiki, Okayama-ken, 710-0813
Sadao Katayama, Site 0034, 0864220753
- Withdrawn
Local Institution - 0107
Kyoto, 616-8255
- Not yet recruiting
Local Institution - 0123
Matsudo, Chiba, 271-0047
Site 0123
- Recruiting
Tominaga Clinic
Osaka, Osaka, 5560015
Takao Takeshima, Site 0035, 06-6568-1601
- Withdrawn
Local Institution - 0037
Wako, Saitama, 351-0111
- Recruiting
Wako Hospital
Wako, Saitama, 351-0111
Syunnsuke Sekine, Site 0112, 0570-06-3311
- Recruiting
National Hospital Organization Hizen Psychiatric Center
Yoshinogari-cho, Kanzaki-gun, Saga-ken, 842-0192
Manabu Hashimoto, Site 0031, 0952523231
France14 sites, 13 recruiting
- Recruiting
Bordeaux University Hospital - Pellegrin
Bordeaux, 33076
Vincent PLANCHE, Site 0012, 0557820116
- Recruiting
Hospices Civils de Lyon - Hôpital Pierre Wertheimer
Bron, Rhône, 69500
Helene MOLLION, Site 0020, 33472357179
- Recruiting
Centre Hospitalier Régional Universitaire de Lille - Hôpital Roger Salengro
Lille, Hauts-de-France, 59037
Marie-Anne MACKOWIAK, Site 0021, 0320446021
- Recruiting
Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone
Marseille, Bouches-du-Rhône, 13005
Mathieu Ceccaldi, Site 0015, 33491384717
- Recruiting
Centre Hospitalier Universitaire Régional de Nancy
Nancy, Meurthe-et-Moselle, 54035
Therese Jonveaux, Site 0016, 33383154939
- Recruiting
Assistance Publique Hôpitaux de Paris - Groupe Hospitalier 10e - Hôpital Lariboisière
Paris, 75010
Julien Dumurgier, Site 0014, ----0140054313
- Recruiting
Hôpital Broca
Paris, 75013
Hermine LENOIR, Site 0036, 0033144083509
- Recruiting
Pitie Salpetriere University Hospital
Paris, 75013
Theophile Bieth, Site 0102, +33142167502
- Recruiting
Centre Hospitalier Universitaire de Rennes - Hôpital Pontchaillou
Rennes, Ille-et-Vilaine, 35000
Cezara Hanta, Site 0019, 0299876871
- Recruiting
Hôpital Nord Guillaume-et-René-Laennec / CHU de Nantes
Saint-Herblain, Loire-Atlantique, 44800
Claire Boutoleau-Bretonierre, Site 0127, 33240165422
- Recruiting
Les Hôpitaux Universitaires de Strasbourg - Hôpital de la Robertsau
Strasbourg, 67091
Alix RAVIER, Site 0018, +33388115844
- Recruiting
Centre Hospitalier Universitaire Toulouse - Cité de la Santé
Toulouse, Haute-Garonne, 31000
Pierre-Jean Ousset, Site 0013, 33561776435
- Recruiting
Centre Hospitalier Régional Universitaire de Tours - Hôpital Bretonneau
Tours, Centre-Val de Loire, 37044 Cedex 8
Anna-Chloé Balageas, Site 0128
- Withdrawn
Local Institution - 0017
Villefranche-sur-Saône, Rhône, 69655
United Kingdom8 sites, 8 recruiting
- Recruiting
Re:Cognition Health - Birmingham
Birmingham, B16 8LT
Terence McLoughlin, Site 0005, 00447896241251
- Recruiting
Western General Hospital
Edinburgh, Midlothian, EH4 2XU
Catherine Pennington, Site 0103, 0131 537 3388
- Recruiting
Leeds and York Partnership NHS Foundation Trust
Leeds, LS9 7TF
George Crowther, Site 0111, 07703288239
- Recruiting
The Maudsley Hospital
London, London, City of, SE5 8AZ
Dag Aarsland, Site 0116, 0800 731 2864
- Recruiting
NIHR Manchester Clinical Research Facility
Manchester, England, M13 9WL
Ross Dunne, Site 0097, +447407715609
- Recruiting
NeuroClin Glasgow
Motherwell, ML1 4UF
Jennifer Lynch, Site 0126, +44 141 948 0206
- Recruiting
Warneford Hospital
Oxford, Oxfordshire, OX3 7JX
Qi Pei, Site 0010, 01865 902698
- Recruiting
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, S10 2JF
Dan Blackburn, Site 0118, 01142159101
Spain7 sites, 7 recruiting
- Recruiting
Fundació ACE
Barcelona, Barcelona [Barcelona], 08028
Juan Pablo Tartari Díaz Zorita, Site 0062, 34934304720
- Recruiting
Policlinica Gipuzkoa
Donostia / San Sebastian, Basque Country, 20014
Gurutz Linazasoro, Site 0043, 34943002818
- Recruiting
Complejo Hospitalario Ruber Juan Bravo
Madrid, 28006
Juan Lopez Lozano, Site 0048, +34914211218
- Recruiting
Hospital Universitario 12 de Octubre
Madrid, 28041
Alberto Villarejo Galende, Site 0045, 913908000
- Recruiting
Hospital Universitario Quironsalud Madrid
Pozuelo de Alarcón, Madrid, 28223
RAFAEL ARROYO, Site 0047, +34902151016
- Recruiting
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, 39008
Eloy Rodríguez Rodríguez, Site 0046, 669951025
- Recruiting
Hospital Universitario Doctor Peset
Valencia, Valenciana, Comunitat, 46017
Lamberto Landete Pascual, Site 0044, 34617513880
Argentina6 sites, 6 recruiting
- Recruiting
Hospital Italiano de Buenos Aires
ABB, Buenos Aires F.D., 1181
Daniel Bernardo Seinhart, Site 0029, 005491150416255
- Recruiting
Fundación para la Lucha contra las Enfermedades Neurológicas de la Infancia (FLENI)
Buenos Aires, C1428AQK
Ricardo Allegri, Site 0025, 5491144704855
- Recruiting
Centro Médico Luquez
Córdoba, Córdoba Province, X5006CBI
Juan Luquez, Site 0027, +5493517481586
- Recruiting
CEN Centro Especializado en Neurociencias
Córdoba, 5000
Hernan Ruggeri, Site 0028, 93515339477
- Recruiting
Instituto Médico DAMIC
Córdoba, X5003DCE
Gerardo Garcia Bonetto, Site 0030, +5493516508068
- Recruiting
Resolution Psychopharmacology Research Institute
Mendoza, 5502
Eugenio Velasco, Site 0026, 54-261-9-155861633
Germany6 sites, 6 recruiting
- Recruiting
Private Practice - Dr. Irma Schöll
Bad Homburg, 61348
Elvira Steidl, Site 0024, +4961722679573
- Recruiting
Pharmakologisches Studienzentrum Chemnitz
Chemnitz, 09111
Ralf Bodenschatz, Site 0001, 493727991031
- Recruiting
Universitaetsklinikum Koeln
Cologne, 50937
Franziska Maier, Site 0002, 004922147832888
- Recruiting
Universitätsmedizin Göttingen - Georg-August-Universität
Göttingen, Lower Saxony, 37075
Niels Hansen, Site 0023, 05513956637
- Recruiting
Ludwig-Maximilians-Universität München
Munich, Bavaria, 80539
Robert Perneczky, Site 0004, +4989440053411
- Recruiting
Universitaetsklinikum Ulm
Ulm, 89081
Doerte Polivka, Site 0003, 4973150063089
Portugal6 sites, 6 recruiting
- Recruiting
Hospital de Braga
Braga, 4710-243
Alvaro Machado, Site 0051, 351253027000
- Recruiting
Unidade Local de Saúde de Coimbra, E.P.E.
Coimbra, 3000 075
Isabel Santana, Site 0049, 351239400448
- Recruiting
Centro Hospitalar do Alto Ave - Hospital Senhora da Oliveira
Guimarães, 4800-055
Ana Monteiro, Site 0063
- Recruiting
Unidade Local de Saude de Matosinhos
Matosinhos Municipality, Porto District, 4464-513
Vitor Cruz, Site 0104
- Recruiting
Centro Hospitalar do Porto - Hospital de Santo António
Porto, 4050-014
Ines Laranjinha, Site 0052, 00351915251027
- Recruiting
Campus Neurológico Sénior
Torres Vedras, Lisbon District, 2560-280
Joana Morgado, Site 0050
Finland5 sites, 5 recruiting
- Recruiting
CRST Helsinki Oy
Helsinki, Uusimaa, 00180
Zsófia Lovró, Site 0007, +358 2 42064700
- Recruiting
Terveystalo Kamppi
Helsinki, 00100
Petra Keski-Säntti, Site 0006, +358 9 0030000
- Recruiting
Itä-Suomen Yliopisto Kuopio
Kuopio, 70210
Sudhir Kurl, Site 0008, 358 50 565 0598
- Recruiting
Terveystalo Oulu
Oulu, North Ostrobothnia, 90100
Hanna Ansakorpi, Site 0022, 358 9 0030000
- Recruiting
Clinical Research Services Turku
Turku, Southwest Finland, 20520
Juha Rinne, Site 0009, +358 2 42064700
Greece5 sites, 5 recruiting
- Recruiting
University General Hospital "ATTIKON" - General Hospital of West Attica "H AGIA VARVARA"
Chaïdári, Attikí, 124 62
Georgios Tsivgoulis, Site 0060, +302105832473
- Not yet recruiting
Local Institution - 0059
Ioannina, Ioánnina, 455 00
Site 0059
- Recruiting
Hygeia Hospital
Marousi, Attikí, 151 23
PARASKEVI SAKKA, Site 0061, +302106867079
- Recruiting
University Hospital of Patras
Pátrai, Achaḯa, 26504
John Ellul, Site 0109, +306932447636
- Recruiting
AHEPA University General Hospital of Thessaloniki
Thessaloniki, 546 36
Vasilios Kimiskidis, Site 0110, 00302310994667
Romania5 sites, 4 recruiting
- Recruiting
Prof. Dr. Alexandru Obregia Psychiatry Hospital
Bucharest, Bucharest, 041914
SIMONA TRIFU, Site 0040, 0040731581100
- Recruiting
Prof. Dr. Alexandru Obregia Psychiatry Hospital
Bucharest, Bucharest, 041914
ADELA CIOBANU, Site 0039, 0040723671301
- Withdrawn
Local Institution - 0042
Bucharest, 0
- Recruiting
Brainaxy Clinic
Constanța, Constanța County, 900675
Any Axelerad, Site 0113
- Recruiting
Spitalul de Psihiatrie și Neurologie Brașov
Sanpetru /Brasov, 507190
Petru Ifteni, Site 0041, 0040724993329
Australia4 sites, 4 recruiting
- Recruiting
University of the Sunshine Coast Birtinya
Birtinya, Queensland, 4575
Peter De Wet, Site 0053, 0423764205
- Not yet recruiting
Local Institution - 0055
Herston (rbwh Grounds), Queensland, 4006
Site 0055
- Recruiting
Austin Health
Ivanhoe, Victoria, 3079
Sanka Amadoru, Site 0054, +61 3 9496 5000
- Recruiting
Griffith University - Gold Coast Campus
Southport, Queensland, 4222
Philip Morris, Site 0056, +61 7 5552 7260
Brazil4 sites, 4 recruiting
- Not yet recruiting
Local Institution - 0115
Fortaleza, Ceará, 60135-237
Site 0115
- Recruiting
Clinilive
Maringá, Paraná, 87015-180
Antonio da Silva, Site 0101, 443029-3004
- Recruiting
Ruschel Medicina e Pesquisa Clínica
Rio de Janeiro, 22270-060
Sandra Ruschel, Site 0099, 5521999822072
- Recruiting
CPQuali Pesquisa Clínica
São Paulo, 01228-000
Leonel Takada, Site 0100, 5511971539018
Poland4 sites, 3 recruiting
- Recruiting
EMC Silesia sp. z o.o.
Katowice, Silesian Voivodeship, 40-353
Martyna Zygmuntowska, Site 0065, +48727600366
- Withdrawn
Local Institution - 0108
Lublin, Lublin Voivodeship, 20-064
- Recruiting
Instytut Zdrowia Dr Boczarska Jedynak
Oświęcim, Lesser Poland Voivodeship, 32-600
Magdalena Boczarska-Jedynak, Site 0066, +48-501-485-317
- Recruiting
Penta Hospitals Przychodnie, Wrocław Wejherowska
Wroclaw, Lower Silesian Voivodeship, 54-239
Monika Susz-Kolodynska, Site 0064, +48502380488
Italy3 sites, 3 recruiting
- Recruiting
Azienda Ospedaliero Universitaria Policlinico Riuniti di Foggia
Foggia, 71100
Carlo Avolio, Site 0058, +390881736080
- Recruiting
University of Naples Federico II
Naples, Campania, 80131
Vincenzo Brescia Morra, Site 0057, +39081743741
- Recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore
Roma, 00168
Camillo Marra, Site 0067, +393469467744
Netherlands3 sites, 3 recruiting
- Recruiting
Brain Research Center Den Bosch B.V.
's-Hertogenbosch, North Brabant, 5223 LA
Paul Dautzenberg, Site 0011, +31736996000
- Recruiting
Brain Research Center
Amsterdam, North Holland, 1081 GN
Paul Dautzenberg, Site 0096, +31736996000
- Recruiting
Brain Research Center Zwolle
Zwolle, Overijssel, 8025 AZ
Paul Dautzenberg, Site 0098, +31736996000
Puerto Rico1 site, 1 recruiting
- Recruiting
SCB Research Center
Bayamón, 00961
William Julio, Site 0074, 7872208097
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 2)
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 start21 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
- NCT06976203
- Sponsor's protocol ID
- CN012-0052
- Other IDs
- 2025-520747-32, U1111-1317-4515, 2025
- Acronym
- MINDSET 2
- Status last verified
- Oct 2026
- First submitted
- 9 May 2025
- Last updated
- 8 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