A Study to Evaluate the Efficacy and Safety of KarXT + KarX-EC for Cognitive Impairment in Alzheimer's Disease

Phase 3

Not yet recruiting

• Conditions: Alzheimer's Disease
• Interventions: Drug: KarXT; Other: Placebo; Drug: KarX-EC

• Registration Number: NCT06976216
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of KarXT + KarX-EC for cognitive impairment in Alzheimer's Disease

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-09
• Study First Submitted QC: 2025-05-09
• Last Update Submitted: 2025-05-09
• Study First Posted: 2025-05-16
• Last Update Posted: 2025-05-16
• Study Start: 2025-07-25
• Primary Completion: 2028-09-11
• Study Completion: 2029-02-23

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 586

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
KarXT + KarX-EC	KarXT	-
KarXT + KarX-EC	KarX-EC	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Change from baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale 11 (ADAS-Cog11)	At week 24
Clinician's Interview-Based Impression Plus Caregiver Input (CIBIC+)	At week 24

Secondary Outcome Measures

Name	Time	Method
Change from baseline in Alzheimer's Disease Cooperative Study-Activities of Daily Living scale (ADCS-ADL)	At week 24
Change from baseline in neuro psychiatric inventory (NPI) total score	At week 24
Number of participants with adverse events (AEs)	At week 24
Number of participants with serious adverse events (SAEs)	At week 24
Number of participants with adverse event of special interest (AESIs)	At week 24
Number of participants with AEs leading to study intervention discontinuation	At week 24
Number of participants with AEs leading to study discontinuation	At week 24
Number of participants with AEs leading to death	At week 24
Number of participants with clinically significant changes in vital signs	At week 24
Number of participants with clinically significant changes in electrocardiogram (ECG) tests	At week 24
Number of participants with clinically significant changes in Columbia-Suicide Severity Rating Scale (C-SSRS) tests	At week 24
Number of participants with clinically significant changes in weight	At week 24
Number of participants with clinically significant changes in safety laboratory tests	At week 24

Trial Locations

Locations (113)

Local Institution - 0216; 🇭🇷 Osijek, Croatia

Local Institution - 0267; 🇭🇷 Rijeka, Croatia

Local Institution - 0240; 🇭🇷 Zagreb, Croatia

Local Institution - 0268; 🇷🇴 Iași, Romania

Local Institution - 0173; 🇺🇸 Long Beach, California, United States

Local Institution - 0008; 🇺🇸 Redlands, California, United States

Local Institution - 0025; 🇺🇸 Basalt, Colorado, United States

Local Institution - 0024; 🇺🇸 Washington, District of Columbia, United States

Local Institution - 0215; 🇭🇷 Zagreb, Grad Zagreb, Croatia

Local Institution - 0154; 🇺🇸 Atlantis, Florida, United States

Local Institution - 0128; 🇺🇸 Aventura, Florida, United States

Local Institution - 0023; 🇺🇸 Merritt Island, Florida, United States

Local Institution - 0055; 🇺🇸 Ocala, Florida, United States

Local Institution - 0263; 🇺🇸 Stuart, Florida, United States

Local Institution - 0184; 🇺🇸 The Villages, Florida, United States

Local Institution - 0016; 🇺🇸 Columbus, Georgia, United States

Local Institution - 0125; 🇺🇸 Gainesville, Georgia, United States

Local Institution - 0109; 🇺🇸 Chicago, Illinois, United States

Local Institution - 0054; 🇺🇸 Elk Grove Village, Illinois, United States

Local Institution - 0009; 🇺🇸 Newton, Massachusetts, United States

Local Institution - 0259; 🇺🇸 Watertown, Massachusetts, United States

Local Institution - 0110; 🇺🇸 Saint Paul, Minnesota, United States

Local Institution - 0123; 🇺🇸 Toms River, New Jersey, United States

Local Institution - 0101; 🇺🇸 New York, New York, United States

Local Institution - 0202; 🇺🇸 Syracuse, New York, United States

Local Institution - 0007; 🇺🇸 Charlotte, North Carolina, United States

Local Institution - 0073; 🇺🇸 Columbus, Ohio, United States

Local Institution - 0026; 🇺🇸 Dayton, Ohio, United States

Local Institution - 0067; 🇺🇸 Portland, Oregon, United States

Local Institution - 0004; 🇺🇸 Abington, Pennsylvania, United States

Local Institution - 0056; 🇺🇸 East Providence, Rhode Island, United States

Local Institution - 0099; 🇺🇸 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, Ciudad Autonoma De Buenos Aires, Argentina

Local Institution - 0271; 🇦🇷 Buenos Aires, Argentina

Local Institution - 0228; 🇦🇷 Córdoba, Argentina

Local Institution - 0284; 🇭🇷 Zagreb, Grad Zagreb, Croatia

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, Distrito Federal, Brazil

Local Institution - 0180; 🇧🇷 Curitiba, Paraná, Brazil

Local Institution - 0266; 🇧🇷 Aracaju, Sergipe, Brazil

Local Institution - 0165; 🇧🇷 São Paulo, Brazil

Local Institution - 0233; 🇨🇦 Kelowna, British Columbia, Canada

Local Institution - 0234; 🇨🇦 Richmond, British Columbia, Canada

Local Institution - 0236; 🇨🇦 Halifax, Nova Scotia, Canada

Local Institution - 0237; 🇨🇦 Ottawa, Ontario, Canada

Local Institution - 0235; 🇨🇦 Toronto, Ontario, Canada

Local Institution - 0238; 🇨🇦 Greenfield Park, Quebec, Canada

Local Institution - 0239; 🇨🇦 Victoriaville, Quebec, Canada

Local Institution - 0264; 🇨🇦 Quebec, Canada

Local Institution - 0230; 🇨🇱 Antofagasta, AN, Chile

Local Institution - 0272; 🇨🇱 Providencia, Región Metropolitana De Santiago, Chile

Local Institution - 0094; 🇨🇱 Santiago, Región Metropolitana De Santiago, Chile

Local Institution - 0089; 🇨🇱 Santiago, Región Metropolitana De Santiago, Chile

Local Institution - 0241; 🇨🇱 Santiago, Región Metropolitana De Santiago, Chile

Local Institution - 0227; 🇨🇿 Brno, Brno-město, Czechia

Local Institution - 0225; 🇨🇿 Olomouc, Olomoucký Kraj, Czechia

Local Institution - 0221; 🇨🇿 Plzen, Plzeň-město, Czechia

Local Institution - 0223; 🇨🇿 Prague, Praha 6, Czechia

Local Institution - 0224; 🇨🇿 Praha, Praha 6, Czechia

Local Institution - 0222; 🇨🇿 Praha, Praha 8, Czechia

Local Institution - 0226; 🇨🇿 Rychnov nad Kněžnou, Czechia

Local Institution - 0217; 🇩🇪 München, Bayern, Germany

Local Institution - 0220; 🇩🇪 Westerstede, Niedersachsen, Germany

Local Institution - 0219; 🇩🇪 Münster, Nordrhein-Westfalen, Germany

Local Institution - 0276; 🇩🇪 Mainz, Rheinland-Pfalz, Germany

Local Institution - 0218; 🇩🇪 Berlin, Germany

Local Institution - 0277; 🇩🇪 Bremen, Germany

Local Institution - 0275; 🇩🇪 Hamburg, Germany

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 - 0281; 🇬🇷 Alexandroupolis, 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; 🇮🇹 Milano, Lombardia, Italy

Local Institution - 0246; 🇮🇹 Milano, Lombardia, Italy

Local Institution - 0248; 🇮🇹 Monza, Lombardia, Italy

Local Institution - 0247; 🇮🇹 Brescia, Italy

Local Institution - 0209; 🇰🇷 Gwangju-si, Kwangju-Kwangyǒkshi, Korea, Republic of

Local Institution - 0214; 🇰🇷 Seongnam, Kyǒnggi-do, Korea, Republic of

Local Institution - 0211; 🇰🇷 Gangseo-gu, Seoul-teukbyeolsi [Seoul], Korea, Republic of

Local Institution - 0213; 🇰🇷 Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of

Local Institution - 0208; 🇰🇷 Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of

Local Institution - 0210; 🇰🇷 Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of

Local Institution - 0212; 🇰🇷 Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of

Local Institution - 0261; 🇵🇱 Torun, Kujawsko-pomorskie, Poland

Local Institution - 0280; 🇵🇱 Bialystok, Podlaskie, Poland

Local Institution - 0260; 🇵🇱 Gdansk, Pomorskie, Poland

Local Institution - 0273; 🇷🇴 Bucharest, București, Romania

Local Institution - 0262; 🇵🇱 Poznań, Wielkopolskie, Poland

Local Institution - 0181; 🇵🇷 San Juan, Puerto Rico

Local Institution - 0278; 🇷🇴 Bucharest, București, Romania

Local Institution - 0269; 🇷🇴 Bucharest, București, Romania

Local Institution - 0270; 🇷🇴 Bucharest, București, Romania

Local Institution - 0255; 🇪🇸 Seville, Andalucía, 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, Navarra, Spain

Local Institution - 0250; 🇪🇸 Madrid, Spain