A Phase 3, Randomized, Double-Blind, Placebo-Controlled Relapse Prevention Study to Evaluate the Safety and Efficacy of KarXT for the Treatment of Psychosis Associated With Alzheimer's Disease

Status: Recruiting
Location: See all (110) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

This is a Phase 3, 38-week, randomized, double-blind, placebo-controlled, multicenter, outpatient study in subjects with psychosis associated with Alzheimer's Disease. The primary objective of the study is to evaluate relapse prevention in subjects with psychosis associated with Alzheimer's Disease treated with KarXT compared to placebo. The secondary objectives of the study are to evaluate the time from randomization to discontinuation for any reason and safety and tolerability in subjects with psychosis associated with Alzheimer's Disease treated with KarXT compared to placebo.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 55
Maximum Age: 90
Healthy Volunteers: f
View:

• Is aged 55 to 90 years, inclusive, at Screening

• Can understand the nature of the study and protocol requirements and provide a signed informed consent form before any study assessments are performed. If the subject is deemed not competent to provide consent, the following requirements for consent must be met.

∙ The subject's legally acceptable representative or caregiver/study partner, if local regulations allow, must provide informed consent

‣ The subject must provide informed assent

• Meets clinical criteria for possible or probable Alzheimer's Disease

• Has 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. If not available, a non-contrast brain MRI or non-contrast head CT must be done during screening.

• Living at the same home or residential assisted-living facility for a minimum of six weeks before Screening

• Capable of self-locomotion (alone or with the aid of an assistive device) and have an identified or proxy caregiver (spends approximately 10 hours/week with the subject) that is willing to:

∙ Attend all visits and report on subject's status

‣ Oversee subject compliance with medication and study procedures

‣ Participate in the study assessments and provide informed consent to participate in the study

• History of psychotic symptoms (meeting International Psychogeriatric Association \[IPA\] criteria) for at least 2 months prior to Screening.

• Clinical Global Impressions-Severity (CGI-S) scale with a score ≥4 (moderate) at Screening and Baseline. CGI-S requires the assessor to consider aspects of the psychosis prior to providing a global assessment of severity. These aspects include hallucinations and delusions.

• Subjects are required to meet at least one of the following criteria at Screening and Baseline:

∙ Moderate to severe delusions, defined as Neuropsychiatric Inventory-Clinician (NPI-C): Delusions domain score of ≥2 on two of the eight items OR

‣ Moderate to severe hallucinations, defined as NPI-C: Hallucinations domain score of ≥ 2 on two of the seven items.

⁃ Mini-Mental State Examination (MMSE) score of 8 to 22, inclusive, at Screening

⁃ If the subject is taking a cholinesterase inhibitor and/or memantine, they must have been on a stable dose for 6 weeks prior to Screening and be willing to maintain a stable dose for the duration of the study.

⁃ Subject is willing and able to visit the clinic in an outpatient setting for the study duration, follow instructions, and comply with the protocol requirements

⁃ BMI must be within 18 to 40 kg/m2 inclusive

⁃ Female subjects must not be pregnant or breastfeeding. Women of childbearing potential (WOCBP), or men whose sexual partners are WOCBP, must be able and willing to use at least 1 highly effective method of contraception during the study and for at least 1 menstrual cycle (e.g., 30 days) after the last dose of IMP or matching placebo. Sperm donation is not allowed for 30 days after the final dose of the IMP or matching placebo.

Locations
United States
Alabama
Local Institution - 1029
ACTIVE_NOT_RECRUITING
Homewood
Arizona
Local Institution - 1044
COMPLETED
Phoenix
California
Local Institution - 1033
COMPLETED
Encino
Local Institution - 1031
WITHDRAWN
Irvine
ATP Clinical Research-302 W La Veta Ave
RECRUITING
Orange
Local Institution - 1043
COMPLETED
Pasadena
Local Institution - 1047
ACTIVE_NOT_RECRUITING
San Marcos
Sunwise Clinical Research, LLC - Walnut Creek - IVY - PPDS
RECRUITING
Walnut Creek
Colorado
Local Institution - 1014
COMPLETED
Colorado Springs
Connecticut
Local Institution - 1013
COMPLETED
Stamford
Florida
Local Institution - 1011
COMPLETED
Boca Raton
Envision Trials LLC
RECRUITING
Bonita Springs
Local Institution - 1015
COMPLETED
Bradenton
Local Institution - 1048
ACTIVE_NOT_RECRUITING
Clermont
Arrow Clinical Trials
RECRUITING
Daytona Beach
Local Institution - 1045
ACTIVE_NOT_RECRUITING
Doral
Local Institution - 1024
WITHDRAWN
Hialeah
Local Institution - 1046
ACTIVE_NOT_RECRUITING
Hialeah
Local Institution - 1052
ACTIVE_NOT_RECRUITING
Hialeah
Local Institution - 1049
ACTIVE_NOT_RECRUITING
Homestead
K2 Medical Research - Maitland
RECRUITING
Maitland
Coral Research Clinic & Coral Diagnostic Center
RECRUITING
Miami
Floridian Neuroscience Institute-1901 SW 1 St
RECRUITING
Miami
Local Institution - 1005
COMPLETED
Miami
Local Institution - 1009
ACTIVE_NOT_RECRUITING
Miami
Local Institution - 1010
COMPLETED
Miami
Local Institution - 1042
ACTIVE_NOT_RECRUITING
Miami
Local Institution - 1111
ACTIVE_NOT_RECRUITING
Miami
Local Institution - 1129
ACTIVE_NOT_RECRUITING
Miami
Local Institution - 1143
ACTIVE_NOT_RECRUITING
Miami
Novel Clinical Research Center, LLC.
RECRUITING
Miami
Premier Clinical Research Institute
RECRUITING
Miami
South Florida Research Phase I-IV, Inc. - Miami
RECRUITING
Miami
Local Institution - 1032
ACTIVE_NOT_RECRUITING
Miami Lakes
Local Institution - 1026
ACTIVE_NOT_RECRUITING
Miami Springs
Local Institution - 1027
WITHDRAWN
Ocala
Local Institution - 1012
COMPLETED
Pensacola
Local Institution - 1008
ACTIVE_NOT_RECRUITING
St. Petersburg
K2 Medical Research - Tampa
RECRUITING
Tampa
Local Institution - 1050
ACTIVE_NOT_RECRUITING
Tampa
Local Institution - 1040
WITHDRAWN
The Villages
Illinois
Local Institution - 1037
COMPLETED
Chicago
New York
Local Institution - 1018
ACTIVE_NOT_RECRUITING
Manhasset
Local Institution - 1017
COMPLETED
New York
Local Institution - 1030
WITHDRAWN
New York
Local Institution - 1051
COMPLETED
New York
Local Institution - 1002
ACTIVE_NOT_RECRUITING
Staten Island
Local Institution - 1034
COMPLETED
Stony Brook
Five Towns Neurology, PC
RECRUITING
Woodmere
Ohio
Local Institution - 1003
WITHDRAWN
Canton
Oklahoma
Local Institution - 1016
COMPLETED
Oklahoma City
Local Institution - 1028
WITHDRAWN
Oklahoma City
Pennsylvania
Local Institution - 1019
ACTIVE_NOT_RECRUITING
Allentown
South Carolina
Local Institution - 1035
ACTIVE_NOT_RECRUITING
Charleston
Tennessee
Local Institution - 1038
COMPLETED
Franklin
Texas
Local Institution - 1022
COMPLETED
Flower Mound
Local Institution - 1036
COMPLETED
Frisco
Clinical Trial Network - 7080 Southwest Fwy
RECRUITING
Houston
Other Locations
Bulgaria
Medical Center Medconsult Pleven OOD
RECRUITING
Pleven
Local Institution - 4502
COMPLETED
Sofia
Local Institution - 4505
COMPLETED
Sofia
Medical Center Sveti Naum EOOD
RECRUITING
Sofia
Local Institution - 4504
COMPLETED
Vratsa
Croatia
Klinika za psihijatriju Vrapce
RECRUITING
Zagreb
Local Institution - 4102
ACTIVE_NOT_RECRUITING
Zagreb
Local Institution - 4103
COMPLETED
Zagreb
Local Institution - 4105
ACTIVE_NOT_RECRUITING
Zagreb
Psychiatric Clinic Sveti Ivan
RECRUITING
Zagreb
France
Local Institution - 2502
ACTIVE_NOT_RECRUITING
Dijon
Local Institution - 2501
ACTIVE_NOT_RECRUITING
Reims
Local Institution - 2503
COMPLETED
Rouen
Germany
Local Institution - 2403
WITHDRAWN
Bayreuth
Local Institution - 2401
COMPLETED
Böblingen
Local Institution - 2402
WITHDRAWN
Homburg
Italy
Local Institution - 2306
ACTIVE_NOT_RECRUITING
Baggiovara
Local Institution - 2308
COMPLETED
Florence
Local Institution - 2304
COMPLETED
Milan
Local Institution - 2305
COMPLETED
Monza
Local Institution - 2302
COMPLETED
Pisa
Local Institution - 2307
ACTIVE_NOT_RECRUITING
Ponderano (biella)
Local Institution - 2303
ACTIVE_NOT_RECRUITING
Roma
Local Institution - 2309
COMPLETED
Roma
Local Institution - 2301
COMPLETED
Rome
Serbia
Clinical Hospital Center Dragisa Misovic Dedinje
RECRUITING
Belgrade
Local Institution - 4307
COMPLETED
Belgrade
Military Medical Academy
RECRUITING
Belgrade
Military Medical Academy
RECRUITING
Belgrade
University Clinical Center of Serbia - Pasterova 2 - PPDS
RECRUITING
Belgrade
Special Hospital for Psychiatric Diseases Kovin
RECRUITING
Kovin
University Clinical Center Kragujevac
RECRUITING
Kragujevac
University Clinical Center Kragujevac
RECRUITING
Kragujevac
University Clinical Center Kragujevac
RECRUITING
Kragujevac
Clinical Centre of Vojvodina
RECRUITING
Novi Sad
Local Institution - 4311
COMPLETED
Vršac
Slovakia
MUDr. Beata Dupejova, Neurologicka ambulancia, s.r.o.
RECRUITING
Banská Bystrica
KONZILIUM s.r.o
RECRUITING
Dubnica Nad Váhom
EPAMED s.r.o
RECRUITING
Košice
Univerzitna nemocnica L Pasteura Kosice-Rastislavova 43
RECRUITING
Košice
Crystal Comfort, s.r.o.
RECRUITING
Vranov Nad Topľou
Local Institution - 4404
WITHDRAWN
Žilina
Spain
Local Institution - 2205
COMPLETED
Barcelona
Local Institution - 2207
ACTIVE_NOT_RECRUITING
Madrid
Complejo Asistencial Universitario de Salamanca - H. Clinico
RECRUITING
Salamanca
Hospital Victoria Eugenia
RECRUITING
Seville
Hospital Universitario Rio Hortega
RECRUITING
Valladolid
Hospital Provincial de Zamora
RECRUITING
Zamora
Hospital Viamed Montecanal
RECRUITING
Zaragoza
United Kingdom
Local Institution - 2105
WITHDRAWN
Aberdeen
Local Institution - 2104
WITHDRAWN
Motherwell
Local Institution - 2103
WITHDRAWN
Swindon
Contact Information
Primary
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
Clinical.Trials@bms.com
855-907-3286
Backup
First line of the email MUST contain the NCT# and Site #.
Time Frame
Start Date: 2022-08-23
Estimated Completion Date: 2026-10-05
Participants
Target number of participants: 380
Treatments
Experimental: KarXT
Xanomeline and Trospium Chloride Capsules
Placebo_comparator: Placebo
Placebo Capsules
Related Therapeutic Areas
Sponsors
Leads: Karuna Therapeutics

This content was sourced from clinicaltrials.gov