A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Psychosis Associated With Alzheimer's Disease
Status: Recruiting
Location: See all (22) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
The purpose of this study is to evaluate KarXT + KarX-EC as a treatment for psychosis associated with Alzheimer's disease.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 55
Maximum Age: 90
Healthy Volunteers: f
View:
• Participants must be 55 to 90 years of age, inclusive, at the time of Screening (Visit 1).
• Participants must be diagnosed with Alzheimer's disease in accordance with the 2024 revised criteria for diagnosis and staging of Alzheimer's Disease: Alzheimer's Association Workgroup.
• Participants must have a magnetic resonance imaging (MRI) or computed tomography (CT) scan of the brain (completed within the past 5 years) taken during or subsequent to the onset of dementia to rule out other central nervous system (CNS) disease that could account for the dementia syndrome, eg, major stroke, neoplasm, subdural hematoma.
• Participants must have a history of psychotic symptoms (meeting International Psychogeriatric Association criteria) for at least 2 months prior to Screening (Visit 1) (participants may or may not have symptoms of agitation).
Locations
United States
Arizona
Gilbert Neurology Partners/CCT Research
RECRUITING
Gilbert
California
Inland Psychiatric Medical Group.
RECRUITING
Chino
Florida
Local Institution - 0001
WITHDRAWN
Naples
Local Institution - 1401
NOT_YET_RECRUITING
Naples
Ohio
Local Institution - 0029
NOT_YET_RECRUITING
Cleveland
Local Institution - 0043
NOT_YET_RECRUITING
Shaker Heights
Other Locations
Australia
Local Institution - 0020
NOT_YET_RECRUITING
Macquarie Park
Local Institution - 0052
NOT_YET_RECRUITING
Nedlands
Canada
Local Institution - 0025
NOT_YET_RECRUITING
Montreal
Local Institution - 0054
NOT_YET_RECRUITING
Toronto
Local Institution - 0027
NOT_YET_RECRUITING
Whitby
Japan
Local Institution - 0035
NOT_YET_RECRUITING
Nankoku-shi
Local Institution - 0034
NOT_YET_RECRUITING
Osaka
Local Institution - 0040
NOT_YET_RECRUITING
Suita
United Kingdom
Local Institution - 0009
NOT_YET_RECRUITING
Chertsey
Local Institution - 0005
NOT_YET_RECRUITING
Exeter
Local Institution - 0023
NOT_YET_RECRUITING
London
Local Institution - 0024
NOT_YET_RECRUITING
London
Local Institution - 0004
NOT_YET_RECRUITING
Motherwell
Local Institution - 0015
NOT_YET_RECRUITING
Oxford
Local Institution - 0018
NOT_YET_RECRUITING
Saint Leonards-on-sea
Local Institution - 0017
NOT_YET_RECRUITING
Sheffield
Contact Information
Primary
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com, www.BMSStudyConnect.com
Clinical.Trials@bms.com
855-907-3286
Backup
First line of the email MUST contain NCT # and Site #.