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
Led by Bristol-Myers Squibb · Updated on 2026-05-28
586
Participants Needed
106
Research Sites
23 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the combination of KarXT and 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 the efficacy and safety of these treatments compared to placebo. The study is sponsored by Bristol-Myers Squibb and focuses on measuring changes in cognitive function and clinical impression over 24 weeks. Participants will receive either KarXT plus KarX-EC or a matching placebo with specified doses on certain days. The study includes a treatment period lasting 24 weeks during which participants are monitored closely. The design involves parallel groups to compare outcomes between the active treatment and placebo. During the trial, participants will undergo assessments including the Alzheimer's Disease Assessment Scale-Cognitive Subscale 11 (ADAS-Cog11) and the Clinician's Interview-Based Impression Plus Caregiver Input (CIBIC+) at week 24. Additional evaluations include daily living activities, neuropsychiatric inventory scores, and safety monitoring such as vital signs, ECG, laboratory tests, and adverse event tracking. The total participation time spans 24 weeks, with safety and efficacy monitored throughout.
CONDITIONS
Brief Title
A Study to Evaluate the Efficacy and Safety of KarXT + KarX-EC for Cognitive Impairment in Alzheimer's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed diagnosis of mild (stage 4) or moderate (stage 5) Alzheimer's Disease using 2024 revised NIA-AA criteria
- Mini-Mental State Examination (MMSE) score between 12 and 22 inclusive at screening
- Have a caregiver who spends about 10 or more hours per week with the participant, willing to attend all study visits and report on condition
- Stable dose of acetyl choline esterase inhibitors and/or memantine for at least 12 weeks before screening and agree to maintain it during the study
- Age between 60 and 85 years
You will not qualify if you...
- Significant or severe medical conditions such as any grade of hepatic impairment, urinary retention, active biliary disease, moderate to severe renal impairment (eGFR <50 mL/min), unstable hypertension or tachycardia
- Primary psychiatric diagnoses including major depression, schizoaffective disorder, bipolar disorder, or severe psychiatric symptoms affecting cognition or study completion
- History of schizophrenia or chronic psychosis
- Prior exposure to KarXT or treatment with disease-modifying anti-amyloid therapies within 6 months before screening
- Significant pathological findings on brain MRI other than Alzheimer's Disease that affect safety or study procedures
- Other protocol-defined inclusion/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 either KarXT combined with KarX-EC or placebo to evaluate the efficacy and safety for cognitive impairment in Alzheimer's Disease.
Regular visits during treatment period to monitor efficacy and safety
Trial Site Locations
Total: 106 locations
1
Healthy Brain Clinic
Long Beach, California, United States, 90804
Actively Recruiting
2
Anderson Clinical Research
Redlands, California, United States, 92374
Actively Recruiting
3
Mountain Neurological Research Center
Basalt, Colorado, United States, 81621
Actively Recruiting
4
Georgetown University Medical Center
Washington D.C., District of Columbia, United States, 20007
Actively Recruiting
5
JEM Research Institute
Atlantis, Florida, United States, 33462
Actively Recruiting
6
VIN-Julie Schwartzbard
Aventura, Florida, United States, 33180
Actively Recruiting
7
Merritt Island Medical Research, LLC
Merritt Island, Florida, United States, 32952
Actively Recruiting
8
Renstar Medical Research
Ocala, Florida, United States, 34470
Actively Recruiting
9
Alzheimer's Research and Treatment Center
Stuart, Florida, United States, 34997
Actively Recruiting
10
Charter Research - Lady Lake
The Villages, Florida, United States, 32162
Actively Recruiting
11
Local Institution - 0016
Columbus, Georgia, United States, 31909
Withdrawn
12
Center for Advanced Research & Education
Gainesville, Georgia, United States, 30501
Actively Recruiting
13
Re:Cognition Health - Chicago
Chicago, Illinois, United States, 60611
Actively Recruiting
14
Ascension Alexian Brothers
Elk Grove Village, Illinois, United States, 60007
Actively Recruiting
15
Boston Center for Memory
Newton, Massachusetts, United States, 02459
Actively Recruiting
16
HealthPartners Neuroscience Center
Saint Paul, Minnesota, United States, 55130
Actively Recruiting
17
Advanced Memory Research Institute of New Jersey
Toms River, New Jersey, United States, 08755
Actively Recruiting
18
NYU Langone Health
New York, New York, United States, 10016
Actively Recruiting
19
Local Institution - 0259
New York, New York, United States, 10029
Active, Not Recruiting
20
SUNY Upstate Medical University
Syracuse, New York, United States, 13210
Actively Recruiting
21
AMC Research, LLC
Matthews, North Carolina, United States, 28105
Actively Recruiting
22
Ohio State University
Columbus, Ohio, United States, 43221
Actively Recruiting
23
NDx Clinical Research Inc.
Dayton, Ohio, United States, 45459
Actively Recruiting
24
Summit Headlands
Portland, Oregon, United States, 97210
Actively Recruiting
25
Local Institution - 0004
Abington, Pennsylvania, United States, 19001
Withdrawn
26
Rhode Island Mood & Memory Research Institute
East Providence, Rhode Island, United States, 02914
Actively Recruiting
27
Neurology Clinic, P.C.
Cordova, Tennessee, United States, 38018
Actively Recruiting
28
Gadolin Research
Beaumont, Texas, United States, 77702
Actively Recruiting
29
Fundación para el Estudio y Tratamiento de Enfermedades Mentales (FETEM)
Buenos Aires, Buenos Aires F.D., Argentina, 1133
Actively Recruiting
30
Local Institution - 0271
Buenos Aires, Argentina, 1280
Not Yet Recruiting
31
Fundación Lennox - Instituto Modelo de Neurología
Córdoba, Argentina, 5000
Actively Recruiting
32
Sanatorio Morra S.A.
Córdoba, Argentina, 5000
Actively Recruiting
33
Instituto Kremer
Córdoba, Argentina, X5004AOA
Actively Recruiting
34
Southern Neurology
Kogarah, New South Wales, Australia, 2217
Actively Recruiting
35
KARA Institute for Neurological Diseases
Macquarie Park, New South Wales, Australia, 2113
Actively Recruiting
36
NeuroCentrix
Carlton, Victoria, Australia, 3053
Actively Recruiting
37
Neurodegenerative Disorders Research
Perth, Western Australia, Australia, 6005
Actively Recruiting
38
St Vincent's Hospital Sydney Limited
Darlinghurst, Australia, 2010
Actively Recruiting
39
Local Institution - 0168
Brasília, Federal District, Brazil, 70200730
Not Yet Recruiting
40
Instituto de Neurologia de Curitiba
Curitiba, Paraná, Brazil, 81210310
Actively Recruiting
41
Local Institution - 0266
Aracaju, Sergipe, Brazil, 49075-000
Not Yet Recruiting
42
Hospital das Clinicas FMUSP
São Paulo, Brazil, 05403-000
Actively Recruiting
43
OCT Research ULC
Kelowna, British Columbia, Canada, V1Y 1Z9
Actively Recruiting
44
Richmond Clinical Trials
Richmond, British Columbia, Canada, V6V 2L1
Actively Recruiting
45
Centricity Research Halifax Multispecialty
Halifax, Nova Scotia, Canada, B3S 1N2
Actively Recruiting
46
Ottawa Memory Clinic
Ottawa, Ontario, Canada, K1Z 1G3
Actively Recruiting
47
Toronto Memory Program
Toronto, Ontario, Canada, M3B 2S7
Actively Recruiting
48
MoCA Research and Innovation Inc.
Greenfield Park, Quebec, Canada, J4V 2J2
Actively Recruiting
49
Diex Recherche Victoriaville
Victoriaville, Quebec, Canada, G6P 3Z8
Actively Recruiting
50
ALPHA Recherche Clinique
Québec, Canada, G3K 2P8
Actively Recruiting
51
Local Institution - 0094
Santiago, Santiago Metropolitan, Chile, 7500710
Not Yet Recruiting
52
Local Institution - 0089
Santiago, Santiago Metropolitan, Chile, 7560356
Not Yet Recruiting
53
Local Institution - 0241
Santiago, Santiago Metropolitan, Chile, 8380420
Not Yet Recruiting
54
Local Institution - 0230
Antofagasta, Chile, 1270244
Not Yet Recruiting
55
Local Institution - 0215
Zagreb, City of Zagreb, Croatia, 10000
Not Yet Recruiting
56
Poliklinika Neuron
Zagreb, City of Zagreb, Croatia, 10000
Actively Recruiting
57
Klinika za psihijatriju "Vrapče"
Zagreb, Croatia, 10090
Actively Recruiting
58
Neuro Health Centrum
Brno, Brno-město, Czechia, 628 00
Actively Recruiting
59
AGE Centrum
Olomouc, Olomouc Region, Czechia, 779 00
Actively Recruiting
60
A-Shine
Pilsen, Plzeň-město, Czechia, 301 00
Actively Recruiting
61
Neurologická Ambulance - Forbeli
Prague, Praha 6, Czechia, 160 00
Actively Recruiting
62
Neuropsychiatrie
Prague, Praha 6, Czechia, 160 00
Actively Recruiting
63
Institut neuropsychiatricke pece (INEP), Praha
Prague, Praha 8, Czechia, 18600
Actively Recruiting
64
Vestra Clinics
Rychnov nad Kněžnou, Czechia, 516 01
Actively Recruiting
65
Universitätsklinikum Münster - Albert Schweitzer Campus
Münster, North Rhine-Westphalia, Germany, 48149
Actively Recruiting
66
Universitätsmedizin Johannes Gutenberg Universität Mainz
Mainz, Rhineland-Palatinate, Germany, 55131
Actively Recruiting
67
Local Institution - 0218
Berlin, Germany, 13125
Not Yet Recruiting
68
Local Institution - 0277
Bremen, Germany, 28325
Withdrawn
69
Local Institution - 0275
Hamburg, Germany, 20246
Withdrawn
70
TUM Klinikum
Munich, Germany, 81675
Actively Recruiting
71
University General Hospital of Alexandroupoli
Alexandroupoli, Anatolikí Makedonía Kai Thráki, Greece, 681 00
Actively Recruiting
72
Local Institution - 0256
Athens, Attikí, Greece, 115 25
Withdrawn
73
Aiginiteio University Hospital
Athens, Attikí, Greece, 115 28
Actively Recruiting
74
University General Hospital of Larissa
Larissa, Thessalía, Greece, 41110
Actively Recruiting
75
Local Institution - 0288
Bengaluru, Karnataka, India, 560029
Not Yet Recruiting
76
Local Institution - 0282
Hyderabad, Telangana, India, 500034
Not Yet Recruiting
77
Local Institution - 0285
Hyderabad, Telangana, India, 500082
Not Yet Recruiting
78
Local Institution - 0287
Varanasi, Uttar Pradesh, India, 221005
Not Yet Recruiting
79
Local Institution - 0286
Kolkata, West Bengal, India, 700054
Not Yet Recruiting
80
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Milan, Lombardy, Italy, 20122
Actively Recruiting
81
Ospedale San Raffaele
Milan, Lombardy, Italy, 20132
Actively Recruiting
82
Fondazione IRCCS San Gerardo dei Tintori
Monza, Lombardy, Italy, 20900
Actively Recruiting
83
Azienda Ospedaliera Spedali Civili di Brescia
Brescia, Italy, 25123
Actively Recruiting
84
Centrum Medyczne HCP
Poznan, Greater Poland Voivodeship, Poland, 61-485
Actively Recruiting
85
Osrodek Badan Klinicznych CLINSANTE S.C.
Torun, Kuyavian-Pomeranian Voivodeship, Poland, 87-100
Actively Recruiting
86
MlynowaMed Psychiatric
Bialystok, Podlaskie Voivodeship, Poland, 15-404
Actively Recruiting
87
Centrum Badan Klinicznych PI-House sp. z o.o.
Gdansk, Pomeranian Voivodeship, Poland, 80-546
Actively Recruiting
88
Instituto De Neurologia Dra. Ivonne Fraga
San Juan, Puerto Rico, 00918
Actively Recruiting
89
Local Institution - 0273
Bucharest, Bucharest, Romania, 041914
Not Yet Recruiting
90
Prof. Dr. Alexandru Obregia Psychiatry Hospital
Bucharest, Bucharest, Romania, 041914
Actively Recruiting
91
Prof. Dr. Alexandru Obregia Psychiatry Hospital
Bucharest, Bucharest, Romania, 041914
Actively Recruiting
92
Institutul Național de Gerontologie și Geriatrie "Ana Aslan"
Bucharest, Romania, 011241
Actively Recruiting
93
Institutul de Psihiatrie Socola
Iași, Romania, 700282
Actively Recruiting
94
Chonnam National University Hospital
Gwangju, Kwangju-Kwangyǒkshi, South Korea, 61469
Actively Recruiting
95
Seoul National University Bundang Hospital
Seongnam, Kyǒnggi-do, South Korea, 13620
Actively Recruiting
96
Seoul National University Hospital
Seoul, Seoul-teukbyeolsi [Seoul], South Korea, 03080
Actively Recruiting
97
Hanyang University Seoul Hospital
Seoul, Seoul-teukbyeolsi [Seoul], South Korea, 04763
Actively Recruiting
98
Konkuk University Medical Center
Seoul, Seoul-teukbyeolsi [Seoul], South Korea, 05030
Actively Recruiting
99
Samsung Medical Center
Seoul, Seoul-teukbyeolsi [Seoul], South Korea, 06351
Actively Recruiting
100
Ewha Womans University Seoul Hospital
Seoul, Seoul-teukbyeolsi [Seoul], South Korea, 07804
Actively Recruiting
101
Hospital Victoria Eugenia
Seville, Andalusia, Spain, 41009
Actively Recruiting
102
Hospital Universitari General de Catalunya
Sant Cugat del Vallès, Barcelona [Barcelona], Spain, 08915
Actively Recruiting
103
Hospital Clínic de Barcelona
Barcelona, Catalunya [Cataluña], Spain, 08036
Actively Recruiting
104
Hospital Universitari de Santa Maria
Lleida, Lleida [Lérida], Spain, 25198
Actively Recruiting
105
Clinica Universidad de Navarra
Pamplona, Navarre, Spain, 31008
Actively Recruiting
106
Hospital Clinico San Carlos
Madrid, Spain, 28040
Actively Recruiting
Research Team
B
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
F
First line of the email MUST contain NCT # and Site #.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here