A Study to Evaluate the Efficacy and Safety of KarXT + KarX-EC for Cognitive Impairment in Alzheimer's Disease
NCT ID: NCT06976216
Last Updated: 2025-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
586 participants
INTERVENTIONAL
2025-07-14
2029-02-23
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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KarXT + KarX-EC
KarXT
Specified dose on specified days
KarX-EC
Specified dose on specified days
Placebo
Placebo
Specified dose on specified days
Interventions
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KarXT
Specified dose on specified days
KarX-EC
Specified dose on specified days
Placebo
Specified dose on specified days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
60 Years
85 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Healthy Brain Clinic
Long Beach, California, United States
Anderson Clinical Research
Redlands, California, United States
Mountain Neurological Research Center
Basalt, Colorado, United States
Local Institution - 0024
Washington D.C., District of Columbia, United States
JEM Research Institute
Atlantis, Florida, United States
VIN-Julie Schwartzbard
Aventura, Florida, United States
Merritt Island Medical Research, LLC
Merritt Island, Florida, United States
Local Institution - 0055
Ocala, Florida, United States
Alzheimer's Research and Treatment Center
Stuart, Florida, United States
Charter Research - Lady Lake
The Villages, Florida, United States
Local Institution - 0016
Columbus, Georgia, United States
Center for Advanced Research & Education
Gainesville, Georgia, United States
Local Institution - 0109
Chicago, Illinois, United States
Ascension Alexian Brothers
Elk Grove Village, Illinois, United States
Boston Center for Memory
Newton, Massachusetts, United States
HealthPartners Neuroscience Center
Saint Paul, Minnesota, United States
Advanced Memory Research Institute of New Jersey
Toms River, New Jersey, United States
Local Institution - 0101
New York, New York, United States
Adams Clinical Harlem
New York, New York, United States
SUNY Upstate Medical University
Syracuse, New York, United States
AMC Research, LLC
Matthews, North Carolina, United States
Ohio State University
Columbus, Ohio, United States
Local Institution - 0026
Dayton, Ohio, United States
Summit Headlands
Portland, Oregon, United States
Local Institution - 0004
Abington, Pennsylvania, United States
Rhode Island Mood & Memory Research Institute
East Providence, Rhode Island, United States
Neurology Clinic, P.C.
Cordova, Tennessee, United States
Local Institution - 0152
Knoxville, Tennessee, United States
Local Institution - 0018
Beaumont, Texas, United States
Local Institution - 0088
Banfield, Buenos Aires, Argentina
Local Institution - 0001
Buenos Aires, Buenos Aires F.D., Argentina
Local Institution - 0271
Buenos Aires, , Argentina
Local Institution - 0228
Córdoba, , Argentina
Local Institution - 0232
Córdoba, , Argentina
Local Institution - 0085
Córdoba, , Argentina
Local Institution - 0279
Kogarah, New South Wales, Australia
Local Institution - 0245
Macquarie Park, New South Wales, Australia
Local Institution - 0244
Sydney, New South Wales, Australia
Local Institution - 0242
Carlton, Victoria, Australia
Local Institution - 0243
Perth, Western Australia, Australia
Local Institution - 0168
Brasília, Federal District, Brazil
Local Institution - 0180
Curitiba, Paraná, Brazil
Local Institution - 0266
Aracaju, Sergipe, Brazil
Local Institution - 0165
São Paulo, , Brazil
OCT Research ULC
Kelowna, British Columbia, Canada
Richmond Clinical Trials
Richmond, British Columbia, Canada
Centricity Research Halifax Multispecialty
Halifax, Nova Scotia, Canada
Ottawa Memory Clinic
Ottawa, Ontario, Canada
Toronto Memory Program
Toronto, Ontario, Canada
MoCA Research and Innovation Inc.
Greenfield Park, Quebec, Canada
Local Institution - 0239
Victoriaville, Quebec, Canada
ALPHA Recherche Clinique
Québec, , Canada
Local Institution - 0230
Antofagasta, AN, Chile
Local Institution - 0272
Providencia, Santiago Metropolitan, Chile
Local Institution - 0094
Santiago, Santiago Metropolitan, Chile
Local Institution - 0089
Santiago, Santiago Metropolitan, Chile
Local Institution - 0241
Santiago, Santiago Metropolitan, Chile
Local Institution - 0215
Zagreb, City of Zagreb, Croatia
Local Institution - 0284
Zagreb, City of Zagreb, Croatia
Local Institution - 0216
Osijek, , Croatia
Local Institution - 0267
Rijeka, , Croatia
Local Institution - 0240
Zagreb, , Croatia
Local Institution - 0227
Brno, Brno-město, Czechia
Local Institution - 0225
Olomouc, Olomoucký kraj, Czechia
Local Institution - 0221
Pilsen, Plzeň-město, Czechia
Local Institution - 0223
Prague, Praha 6, Czechia
Local Institution - 0224
Prague, Praha 6, Czechia
Local Institution - 0222
Prague, Praha 8, Czechia
Local Institution - 0226
Rychnov nad Kněžnou, , Czechia
Local Institution - 0217
München, Bavaria, Germany
Local Institution - 0219
Münster, North Rhine-Westphalia, Germany
Local Institution - 0276
Mainz, Rhineland-Palatinate, Germany
Local Institution - 0218
Berlin, , Germany
Local Institution - 0277
Bremen, , Germany
Local Institution - 0275
Hamburg, , Germany
Local Institution - 0281
Alexandroupoli, Anatolikí Makedonía Kai Thráki, Greece
Local Institution - 0256
Athens, Attikí, Greece
Local Institution - 0274
Athens, Attikí, Greece
Local Institution - 0251
Thessaloniki, Thessaloníki, Greece
Local Institution - 0257
Larissa, Thessalía, Greece
Local Institution - 0288
Bengaluru, Karnataka, India
Local Institution - 0282
Hyderabad, Telangana, India
Local Institution - 0285
Hyderabad, Telangana, India
Local Institution - 0287
Varanasi, Uttar Pradesh, India
Local Institution - 0286
Kolkata, West Bengal, India
Local Institution - 0249
Milan, Lombardy, Italy
Local Institution - 0246
Milan, Lombardy, Italy
Local Institution - 0248
Monza, Lombardy, Italy
Local Institution - 0247
Brescia, , Italy
Local Institution - 0262
Poznan, Greater Poland Voivodeship, Poland
Local Institution - 0261
Torun, Kuyavian-Pomeranian Voivodeship, Poland
Local Institution - 0280
Bialystok, Podlaskie Voivodeship, Poland
Local Institution - 0260
Gdansk, Pomeranian Voivodeship, Poland
Local Institution - 0181
San Juan, , Puerto Rico
Local Institution - 0269
Bucharest, București, Romania
Local Institution - 0270
Bucharest, București, Romania
Local Institution - 0273
Bucharest, București, Romania
Local Institution - 0278
Bucharest, , Romania
Local Institution - 0268
Iași, , Romania
Chonnam National University Hospital
Gwangju, Kwangju-Kwangyǒkshi, South Korea
Seoul National University Bundang Hospital
Seongnam, Kyǒnggi-do, South Korea
Ewha Womans University Seoul Hospital
Gangseo-gu, Seoul-teukbyeolsi [Seoul], South Korea
Seoul National University Hospital
Seoul, Seoul-teukbyeolsi [Seoul], South Korea
Local Institution - 0208
Seoul, Seoul-teukbyeolsi [Seoul], South Korea
Konkuk University Medical Center
Seoul, Seoul-teukbyeolsi [Seoul], South Korea
Samsung Medical Center
Seoul, Seoul-teukbyeolsi [Seoul], South Korea
Local Institution - 0255
Seville, Andalusia, Spain
Local Institution - 0254
Sant Cugat del Vallès, Barcelona [Barcelona], Spain
Local Institution - 0258
Barcelona, Catalunya [Cataluña], Spain
Local Institution - 0253
Lleida, Lleida [Lérida], Spain
Local Institution - 0252
Pamplona, Navarre, Spain
Local Institution - 0250
Madrid, , Spain
Countries
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Central Contacts
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BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
Role: CONTACT
Phone: 8559073286
Email: [email protected]
First line of the email MUST contain the NCT# and Site#
Role: CONTACT
Facility Contacts
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Dung Trinh, Site 0173
Role: primary
Donald Anderson, Site 0008
Role: primary
Alison Allen, Site 0025
Role: primary
Site 0024
Role: primary
Linda Pao, Site 0154
Role: primary
Julie Schwartzbard, Site 0128
Role: primary
Wasim Niazi, Site 0023
Role: primary
Site 0055
Role: primary
Adam Falchook, Site 0263
Role: primary
Jeffrey Norton, Site 0184
Role: primary
Site 0016
Role: primary
Chris Recknor, Site 0125
Role: primary
Site 0109
Role: primary
Concetta Forchetti, Site 0054
Role: primary
Paul Solomon, Site 0009
Role: primary
Marcel Hungs, Site 0110
Role: primary
Arun Singh, Site 0123
Role: primary
Site 0101
Role: primary
Patricia Walsh, Site 0259
Role: primary
Sharon Brangman, Site 0202
Role: primary
Mohammad Bolouri, Site 0007
Role: primary
Douglas Scharre, Site 0073
Role: primary
Site 0026
Role: primary
Scott Losk, Site 0067
Role: primary
john stoukides, Site 0056
Role: primary
Thomas Arnold, Site 0099
Role: primary
Site 0152
Role: primary
Site 0018
Role: primary
Site 0088
Role: primary
Site 0001
Role: primary
Site 0271
Role: primary
Site 0228
Role: primary
Site 0232
Role: primary
Site 0085
Role: primary
Site 0279
Role: primary
Site 0245
Role: primary
Site 0244
Role: primary
Site 0242
Role: primary
Site 0243
Role: primary
Site 0168
Role: primary
Site 0180
Role: primary
Site 0266
Role: primary
Site 0165
Role: primary
Eugene Okorie, Site 0233
Role: primary
Harris Lari, Site 0234
Role: primary
Kerrie Schoffer, Site 0236
Role: primary
Richard Bergeron, Site 0237
Role: primary
Manpreet Kaur, Site 0235
Role: primary
Ziad Nasreddine, Site 0238
Role: primary
Site 0239
Role: primary
Claude Patry, Site 0264
Role: primary
Site 0230
Role: primary
Site 0272
Role: primary
Site 0094
Role: primary
Site 0089
Role: primary
Site 0241
Role: primary
Site 0215
Role: primary
Site 0284
Role: primary
Site 0216
Role: primary
Site 0267
Role: primary
Site 0240
Role: primary
Site 0227
Role: primary
Site 0225
Role: primary
Site 0221
Role: primary
Site 0223
Role: primary
Site 0224
Role: primary
Site 0222
Role: primary
Site 0226
Role: primary
Site 0217
Role: primary
Site 0219
Role: primary
Site 0276
Role: primary
Site 0218
Role: primary
Site 0277
Role: primary
Site 0281
Role: primary
Site 0256
Role: primary
Site 0274
Role: primary
Site 0251
Role: primary
Site 0257
Role: primary
Site 0288
Role: primary
Site 0282
Role: primary
Site 0285
Role: primary
Site 0287
Role: primary
Site 0286
Role: primary
Site 0249
Role: primary
Site 0246
Role: primary
Site 0248
Role: primary
Site 0247
Role: primary
Site 0262
Role: primary
Site 0261
Role: primary
Site 0280
Role: primary
Site 0260
Role: primary
Site 0181
Role: primary
Site 0269
Role: primary
Site 0270
Role: primary
Site 0273
Role: primary
Site 0278
Role: primary
Site 0268
Role: primary
Byeong Chae Kim, Site 0209
Role: primary
Ji Won Han, Site 0214
Role: primary
Jee Hyang Jeong, Site 0211
Role: primary
Manho Kim, Site 0213
Role: primary
Site 0208
Role: primary
Seol-Heui Han, Site 0210
Role: primary
Sang Won Seo, Site 0212
Role: primary
Site 0255
Role: primary
Site 0254
Role: primary
Site 0258
Role: primary
Site 0253
Role: primary
Site 0252
Role: primary
Site 0250
Role: primary
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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2025-520746-30
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
U1111-1317-4462
Identifier Type: OTHER
Identifier Source: secondary_id
CN012-0051
Identifier Type: -
Identifier Source: org_study_id