A Study to Evaluate the Efficacy and Safety of KarXT + KarX-EC for Cognitive Impairment in Alzheimer's Disease
NCT06976216 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 586
Last updated 2026-05-07
Summary
The purpose of this study is to evaluate the efficacy and safety of KarXT + KarX-EC for cognitive impairment in Alzheimer's Disease
Conditions
Interventions
- DRUG
-
KarXT
Specified dose on specified days
- DRUG
-
KarX-EC
Specified dose on specified days
- OTHER
-
Placebo
Specified dose on specified days
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Bristol-Myers Squibb · Bristol-Myers Squibb
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 60 Years
- Max Age
- 85 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-07-14
- Primary Completion
- 2028-09-11
- Completion
- 2029-02-23
- FDA Drug
- Yes
Countries
- United States
- Argentina
- Australia
- Brazil
- Canada
- Chile
- Croatia
- Czechia
- Germany
- Greece
- India
- Italy
- Poland
- Puerto Rico
- Romania
- South Korea
- Spain
Study Locations
More Related Trials
-
Dose-Finding Study To Evaluate Safety, Tolerability, and Efficacy of E2609 in Participants With Mild Cognitive Impairment Due to Alzheimer's Disease (Prodromal Alzheimer's Disease) and Mild to Moderate Dementia Due to Alzheimer's Disease
NCT02322021 ·Status: TERMINATED ·Phase: PHASE2
-
GTS21-201 for Alzheimer Disease:GTS-21 Administered Daily for 28 Days to Participants With Probable Alzheimer's Disease
NCT00414622 ·Status: COMPLETED ·Phase: PHASE2
-
Donepezil and Memantine in Moderate to Severe Alzheimer's Disease
NCT00866060 ·Status: UNKNOWN ·Phase: PHASE4
-
The Purpose of This Study is to Evaluate the Safety and Tolerability of X/T+X-EC in Participants With Alzheimer's Disease Who Are Currently Treated With Lecanemab.
NCT07212062 ·Status: NOT_YET_RECRUITING ·Phase: PHASE2
-
Efficacy Study of MPC-7869 to Treat Patients With Alzheimer's
NCT00105547 ·Status: COMPLETED ·Phase: PHASE3
-
A Phase 3 Study of Rotigotine in Combination with Rivastigmine in Mild to Moderate Alzheimer's Disease
NCT06702124 ·Status: RECRUITING ·Phase: PHASE3
-
Clinical Trial to Evaluate the Efficacy and Safety of GV1001 in Alzheimer Patients
NCT03184467 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Evaluate the Efficacy and Safety of ABBV-8E12 in Participants With Early Alzheimer's Disease
NCT02880956 ·Status: COMPLETED ·Phase: PHASE2
-
An Efficacy and Safety Trial of Verubecestat (MK-8931) in Mild to Moderate Alzheimer's Disease (P07738)
NCT01739348 ·Status: TERMINATED ·Phase: PHASE2/PHASE3
-
BPDO-1603 Intervention Trial in Patients With Moderate-to-severe Alzheimer's Disease
NCT04229927 ·Status: UNKNOWN ·Phase: PHASE3
-
A Clinical Study Evaluating the Efficacy and Safety of RPh201 Treatment in Individuals With Alzheimer's Disease With or Without Coexisting Cerebrovascular Disease
NCT03462121 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Evaluate the Efficacy and Safety of MK-1167 in Participants With Alzheimer's Disease Dementia (MK-1167-008)
NCT06721156 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
A Phase II, Multicenter, Double Blind, Placebo-Controlled Safety, Tolerability Study of BMS-708163 in Patients With Mild to Moderate Alzheimer's Disease
NCT00810147 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Evaluate the Safety and Biomarker Effects of RO7269162 in Participants at Risk for or at the Prodromal Stage of Alzheimer's Disease (AD)
NCT06402838 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
A Study of CM383 in Patients With Alzheimer's Disease Related Mild Cognitive Impairment and Mild Alzheimer's Disease
NCT06619613 ·Status: RECRUITING ·Phase: PHASE1
-
A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-1)
NCT07011732 ·Status: RECRUITING ·Phase: PHASE3
-
A Study of a Potential Disease Modifying Treatment in Individuals at Risk for or With a Type of Early Onset AD Caused by a Genetic Mutation
NCT06647498 ·Status: RECRUITING ·Phase: PHASE2/PHASE3
-
Efficacy and Safety of GSK4527226 [AL101] in Participants With Early Alzheimer's Disease
NCT06079190 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
A Study to Evaluate KarXT as a Treatment for Psychosis Associated With Alzheimer's Disease (ADEPT-4)
NCT06585787 ·Status: RECRUITING ·Phase: PHASE3
-
Efficacy and Safety of MK-1167 in Participants With Alzheimer's Disease Dementia Taking Stable Donepezil Treatment (MK-1167-007)
NCT06285240 ·Status: COMPLETED ·Phase: PHASE1
-
Brain Imaging and Mental Disorders of Aging Intervention
NCT00267163 ·Status: COMPLETED ·Phase: PHASE4
-
A Study Evaluating the Efficacy and Safety of Crenezumab Versus Placebo in Participants With Prodromal to Mild Alzheimer's Disease (AD).
NCT02670083 ·Status: TERMINATED ·Phase: PHASE3
-
A Study Of PF-04447943 Compared To Placebo In Subjects With Mild To Moderate Alzheimer's Disease
NCT00930059 ·Status: COMPLETED ·Phase: PHASE2
-
A Study of Potential Disease Modifying Treatments in Individuals at Risk for or With a Type of Early Onset AD Caused by a Genetic Mutation
NCT05552157 ·Status: RECRUITING ·Phase: PHASE2/PHASE3
-
Preliminary Efficacy and Safety Study of ST101 in Alzheimer's Disease
NCT00842673 ·Status: COMPLETED ·Phase: PHASE2