Actively Recruiting
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of KarXT + KarX-EC for Cognitive Impairment in Mild to Moderate Alzheimer's Disease (MINDSET 2)
Led by Bristol-Myers Squibb · Updated on 2026-06-08
586
Participants Needed
126
Research Sites
23 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the efficacy and safety of KarXT combined with KarX-EC for treating cognitive impairment in people with mild to moderate Alzheimer's Disease. This phase 3, randomized, double-blind, placebo-controlled study aims to assess how well this combination works compared to placebo in improving cognitive function and overall condition in affected adults aged 60 to 85 years. Participants will receive either the active drugs KarXT plus KarX-EC or a placebo following a specified dosing schedule. The study lasts 24 weeks, during which participants will be randomly assigned to one of these two groups. The trial is designed to carefully monitor effects and side effects of the treatments under controlled conditions. Throughout the study, participants and their caregivers will attend regular visits where cognitive tests like the ADAS-Cog11 and CIBIC+ will be conducted to track changes from baseline. Additional assessments include daily living activities, neuropsychiatric symptoms, safety labs, vital signs, ECGs, and adverse event monitoring. Caregivers will help report on participant condition and medication adherence, supporting comprehensive evaluation of the treatment's impact over the 24-week period.
CONDITIONS
Brief Title
A Study to Evaluate the Efficacy and Safety of KarXT + KarX-EC for Cognitive Impairment in Alzheimer's Disease (MINDSET 2)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must have a confirmed diagnosis of Alzheimer's disease at mild (stage 4) or moderate (stage 5) dementia stages based on NIA-AA criteria.
- Mini-Mental State Examination (MMSE) score between 12 and 22 at screening.
- Must have a caregiver with around 10 or more hours of contact per week willing to attend study visits and report on condition.
- If taking acetyl choline esterase inhibitors or memantine, dosage must be stable for at least 12 weeks before screening and maintained during the study.
- Age between 60 and 85 years.
You will not qualify if you...
- Significant or severe medical conditions that risk safety or study compliance, including any grade of liver impairment, urinary retention, active biliary disease, moderate to severe kidney impairment (eGFR <50 mL/min), unstable high blood pressure or fast heart rate.
- Primary psychiatric diagnoses like major depression, schizoaffective disorder, bipolar disorder, or severe psychiatric symptoms affecting assessments or study completion.
- History of schizophrenia or chronic psychosis.
- Previous exposure to KarXT or recent (within 6 months) treatment with disease-modifying anti-amyloid therapies for Alzheimer's Disease.
- Significant brain MRI abnormalities at screening that affect safety or study procedures.
- Other protocol-defined inclusion and exclusion criteria.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 24 weeks
Participants receive specified doses of KarXT and KarX-EC or placebo to evaluate efficacy and safety for cognitive impairment in Alzheimer's disease.
Regular visits during the 24-week treatment period
Trial Site Locations
Total: 126 locations
1
Fullerton Neurology and Headache Center
Fullerton, California, United States, 92835
Actively Recruiting
2
Inglewood Clinical
Inglewood, California, United States, 90301
Actively Recruiting
3
Irvine Clinical Research
Irvine, California, United States, 92614
Actively Recruiting
4
Local Institution - 0083
Palo Alto, California, United States, 94304
Not Yet Recruiting
5
Local Institution - 0069
San Diego, California, United States, 92103
Withdrawn
6
Research of the Rockies
Colorado Springs, Colorado, United States, 80919
Actively Recruiting
7
Neuropsychiatric Research Center of Southwest Florida
Fort Myers, Florida, United States, 33912
Actively Recruiting
8
Local Institution - 0086
Hallandale, Florida, United States, 33009
Active, Not Recruiting
9
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States, 32216
Actively Recruiting
10
K2 MEDICAL Research THE VILLAGES
Lady Lake, Florida, United States, 32159
Actively Recruiting
11
Intercoastal Medical Group
Sarasota, Florida, United States, 34239
Actively Recruiting
12
USF Health Byrd Alzheimer's Institute
Tampa, Florida, United States, 33613
Actively Recruiting
13
Alzheimer's Research and Treatment Center
Wellington, Florida, United States, 33414
Actively Recruiting
14
Great Lakes Clinical Trials - Andersonville
Chicago, Illinois, United States, 60640
Actively Recruiting
15
Southern Illinois University School of Medicine
Springfield, Illinois, United States, 62702
Actively Recruiting
16
Josephson Wallack Munshower Neurology, PC
Indianapolis, Indiana, United States, 46256
Actively Recruiting
17
Local Institution - 0080
Watertown, Massachusetts, United States, 02472
Not Yet Recruiting
18
QUEST Research Institute
Farmington Hills, Michigan, United States, 48334
Actively Recruiting
19
Private Practice - Dr. Ronald Louis Schwartz
Hattiesburg, Mississippi, United States, 39401
Actively Recruiting
20
Local Institution - 0119
Ridgewood, New Jersey, United States, 07450
Withdrawn
21
The Cognitive and Research Center of New Jersey
Springfield, New Jersey, United States, 07081
Actively Recruiting
22
Advanced Clinical Institute
West Long Branch, New Jersey, United States, 07764
Actively Recruiting
23
Neurological Associates Albany
Albany, New York, United States, 12208
Actively Recruiting
24
Dent Neurosciences Research Center, Inc
Amherst, New York, United States, 14226
Actively Recruiting
25
University at Buffalo - UBMD Neurology
Buffalo, New York, United States, 14203
Actively Recruiting
26
Local Institution - 0078
Lake Success, New York, United States, 11042
Withdrawn
27
Keystone Clinical Studies
Plymouth Meeting, Pennsylvania, United States, 19462
Actively Recruiting
28
Local Institution - 0081
Dallas, Texas, United States, 75231
Not Yet Recruiting
29
Central Texas Neurology Consultants, PA
Round Rock, Texas, United States, 78681
Actively Recruiting
30
Rainier Clinical Research Center
Renton, Washington, United States, 98057
Actively Recruiting
31
Hospital Italiano de Buenos Aires
ABB, Buenos Aires F.D., Argentina, 1181
Actively Recruiting
32
Centro Médico Luquez
Córdoba, Córdoba Province, Argentina, X5006CBI
Actively Recruiting
33
Local Institution - 0025
Buenos Aires, Argentina, C1428AQK
Not Yet Recruiting
34
CEN Centro Especializado en Neurociencias
Córdoba, Argentina, 5000
Actively Recruiting
35
Instituto Médico DAMIC
Córdoba, Argentina, X5003DCE
Actively Recruiting
36
Resolution Psychopharmacology Research Institute
Mendoza, Argentina, 5502
Actively Recruiting
37
USC Clinical Trials Sunshine Coast
Birtinya, Queensland, Australia, 4575
Actively Recruiting
38
Local Institution - 0055
Herston (rbwh Grounds), Queensland, Australia, 4006
Not Yet Recruiting
39
Griffith University - Gold Coast Campus
Southport, Queensland, Australia, 4222
Actively Recruiting
40
Austin Health
Ivanhoe, Victoria, Australia, 3079
Actively Recruiting
41
Local Institution - 0115
Fortaleza, Ceará, Brazil, 60135-237
Not Yet Recruiting
42
Local Institution - 0101
Maringá, Paraná, Brazil, 87015-180
Not Yet Recruiting
43
Ruschel Medicina e Pesquisa Clínica
Rio de Janeiro, Brazil, 22270-060
Actively Recruiting
44
CPQuali Pesquisa Clínica
São Paulo, Brazil, 01228-000
Actively Recruiting
45
Terveystalo Oulu
Oulu, North Ostrobothnia, Finland, 90100
Actively Recruiting
46
Clinical Research Services Turku
Turku, Southwest Finland, Finland, 20520
Actively Recruiting
47
CRST Helsinki Oy
Helsinki, Uusimaa, Finland, 00180
Actively Recruiting
48
Terveystalo Ruoholahti
Helsinki, Finland, 00180
Actively Recruiting
49
Itä-Suomen Yliopisto Kuopio
Kuopio, Finland, 70210
Actively Recruiting
50
Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone
Marseille, Bouches-du-Rhône, France, 13005
Actively Recruiting
51
Local Institution - 0128
Tours, Centre-Val de Loire, France, 37044 Cedex 8
Not Yet Recruiting
52
Centre Hospitalier Universitaire Toulouse - Cité de la Santé
Toulouse, Haute-Garonne, France, 31000
Actively Recruiting
53
Centre Hospitalier Régional Universitaire de Lille - Hôpital Roger Salengro
Lille, Hauts-de-France, France, 59037
Actively Recruiting
54
Centre Hospitalier Universitaire de Rennes - Hôpital Pontchaillou
Rennes, Ille-et-Vilaine, France, 35000
Actively Recruiting
55
Local Institution - 0127
Saint-Herblain, Loire-Atlantique, France, 44800
Not Yet Recruiting
56
Centre Hospitalier Universitaire Régional de Nancy
Nancy, Meurthe-et-Moselle, France, 54035
Actively Recruiting
57
Hospices Civils de Lyon - Hôpital Pierre Wertheimer
Bron, Rhône, France, 69500
Actively Recruiting
58
Local Institution - 0017
Villefranche-sur-Saône, Rhône, France, 69655
Withdrawn
59
Bordeaux University Hospital - Pellegrin
Bordeaux, France, 33076
Actively Recruiting
60
Assistance Publique Hôpitaux de Paris - Groupe Hospitalier 10e - Hôpital Lariboisière
Paris, France, 75010
Actively Recruiting
61
Hôpital Broca
Paris, France, 75013
Actively Recruiting
62
Pitie Salpetriere University Hospital
Paris, France, 75013
Actively Recruiting
63
Les Hôpitaux Universitaires de Strasbourg - Hôpital de la Robertsau
Strasbourg, France, 67091
Actively Recruiting
64
Local Institution - 0004
Munich, Bavaria, Germany, 80539
Not Yet Recruiting
65
Universitätsmedizin Göttingen - Georg-August-Universität
Göttingen, Lower Saxony, Germany, 37075
Actively Recruiting
66
Private Practice - Dr. Irma Schöll
Bad Homburg, Germany, 61348
Actively Recruiting
67
Pharmakologisches Studienzentrum Chemnitz
Chemnitz, Germany, 09111
Actively Recruiting
68
Universitaetsklinikum Koeln
Cologne, Germany, 50937
Actively Recruiting
69
Universitaetsklinikum Ulm
Ulm, Germany, 89081
Actively Recruiting
70
University Hospital of Patras
Pátrai, Achaḯa, Greece, 26504
Actively Recruiting
71
University General Hospital "ATTIKON" - General Hospital of West Attica "H AGIA VARVARA"
Chaïdári, Attikí, Greece, 124 62
Actively Recruiting
72
Hygeia Hospital
Marousi, Attikí, Greece, 151 23
Actively Recruiting
73
Local Institution - 0059
Ioannina, Ioánnina, Greece, 455 00
Not Yet Recruiting
74
AHEPA University General Hospital of Thessaloniki
Thessaloniki, Greece, 546 36
Actively Recruiting
75
University of Naples Federico II
Naples, Campania, Italy, 80131
Actively Recruiting
76
Azienda Ospedaliero Universitaria Policlinico Riuniti di Foggia
Foggia, Italy, 71100
Actively Recruiting
77
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore
Roma, Italy, 00168
Actively Recruiting
78
Inage Neurology and Memory Clinic
Inage, Chiba, Japan, 263-0043
Actively Recruiting
79
Local Institution - 0123
Matsudo, Chiba, Japan, 271-0047
Not Yet Recruiting
80
Local Institution - 0124
Hiroshima, Hiroshima, Japan, 732-0066
Not Yet Recruiting
81
Local Institution - 0120
Kita-gun, Kagawa-ken, Japan, 761-0793
Not Yet Recruiting
82
Local Institution - 0125
Kamakura, Kanagawa, Japan, 247-8533
Not Yet Recruiting
83
Kokankai Kokan Clinic
Kawasaki, Kanagawa, Japan, 2100852
Actively Recruiting
84
Nippon Medical School Musashi Kosugi Hospital
Kawasaki, Kanagawa, Japan, 211-8533
Actively Recruiting
85
Ina Central Hospital
Ina, Nagano, Japan, 396-0033
Actively Recruiting
86
National Hospital Organization Niigata Hospital
Kashiwazaki, Niigata, Japan, 945-8585
Actively Recruiting
87
Katayama Medical Clinic
Kurashiki, Okayama-ken, Japan, 710-0813
Actively Recruiting
88
Tominaga Clinic
Osaka, Osaka, Japan, 5560015
Actively Recruiting
89
National Hospital Organization Hizen Psychiatric Center
Yoshinogari-cho, Kanzaki-gun, Saga-ken, Japan, 842-0192
Actively Recruiting
90
Local Institution - 0037
Wako, Saitama, Japan, 351-0111
Withdrawn
91
Wako Hospital
Wako, Saitama, Japan, 351-0111
Actively Recruiting
92
Local Institution - 0107
Kyoto, Japan, 616-8255
Not Yet Recruiting
93
Brain Research Center Den Bosch B.V.
's-Hertogenbosch, North Brabant, Netherlands, 5223 LA
Actively Recruiting
94
Brain Research Center
Amsterdam, North Holland, Netherlands, 1081 GN
Actively Recruiting
95
Brain Research Center Zwolle
Zwolle, Overijssel, Netherlands, 8025 AZ
Actively Recruiting
96
Instytut Zdrowia Dr Boczarska Jedynak
Oświęcim, Lesser Poland Voivodeship, Poland, 32-600
Actively Recruiting
97
Penta Hospitals Przychodnie, Wrocław Wejherowska
Wroclaw, Lower Silesian Voivodeship, Poland, 54-239
Actively Recruiting
98
Local Institution - 0108
Lublin, Lublin Voivodeship, Poland, 20-064
Not Yet Recruiting
99
EMC Silesia sp. z o.o.
Katowice, Silesian Voivodeship, Poland, 40-353
Actively Recruiting
100
Campus Neurológico Sénior
Torres Vedras, Lisbon District, Portugal, 2560-280
Actively Recruiting
101
Unidade Local de Saude de Matosinhos
Matosinhos Municipality, Porto District, Portugal, 4464-513
Actively Recruiting
102
Hospital de Braga
Braga, Portugal, 4710-243
Actively Recruiting
103
Unidade Local de Saúde de Coimbra, E.P.E.
Coimbra, Portugal, 3000 075
Actively Recruiting
104
Centro Hospitalar do Alto Ave - Hospital Senhora da Oliveira
Guimarães, Portugal, 4800-055
Actively Recruiting
105
Centro Hospitalar do Porto - Hospital de Santo António
Porto, Portugal, 4050-014
Actively Recruiting
106
SCB Research Center
Bayamón, Puerto Rico, 00961
Actively Recruiting
107
Prof. Dr. Alexandru Obregia Psychiatry Hospital
Bucharest, Bucharest, Romania, 041914
Actively Recruiting
108
Prof. Dr. Alexandru Obregia Psychiatry Hospital
Bucharest, Bucharest, Romania, 041914
Actively Recruiting
109
Local Institution - 0113
Constanța, Constanța County, Romania, 900675
Not Yet Recruiting
110
Local Institution - 0042
Bucharest, Romania, 0
Withdrawn
111
Spitalul de Psihiatrie și Neurologie Brașov
Sanpetru /Brasov, Romania, 507190
Actively Recruiting
112
Fundació ACE
Barcelona, Barcelona [Barcelona], Spain, 08028
Actively Recruiting
113
Policlinica Gipuzkoa
Donostia / San Sebastian, Basque Country, Spain, 20014
Actively Recruiting
114
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, Spain, 39008
Actively Recruiting
115
Hospital Universitario Quironsalud Madrid
Pozuelo de Alarcón, Madrid, Spain, 28223
Actively Recruiting
116
Hospital Universitario Doctor Peset
Valencia, Valenciana, Comunitat, Spain, 46017
Actively Recruiting
117
Complejo Hospitalario Ruber Juan Bravo
Madrid, Spain, 28006
Actively Recruiting
118
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Actively Recruiting
119
NIHR Manchester Clinical Research Facility
Manchester, England, United Kingdom, M13 9WL
Actively Recruiting
120
The Maudsley Hospital
London, London, City of, United Kingdom, SE5 8AZ
Actively Recruiting
121
Local Institution - 0103
Edinburgh, Midlothian, United Kingdom, EH4 2XU
Not Yet Recruiting
122
Warneford Hospital
Oxford, Oxfordshire, United Kingdom, OX3 7JX
Actively Recruiting
123
Re:Cognition Health - Birmingham
Birmingham, United Kingdom, B16 8LT
Actively Recruiting
124
Leeds and York Partnership NHS Foundation Trust
Leeds, United Kingdom, LS9 7TF
Actively Recruiting
125
Local Institution - 0126
Motherwell, United Kingdom, ML1 4UF
Not Yet Recruiting
126
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, United Kingdom, S10 2JF
Actively Recruiting
Research Team
B
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
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How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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