A Study to Evaluate Safety and Efficacy of KarXT + KarX-EC as a Treatment for Psychosis Associated With Alzheimer's Disease (ADEPT-5)

Part of paid clinical trials in Gilbert, Arizona.

Sponsor
Bristol-Myers Squibb
Study ID
NCT06947941
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
55 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

The purpose of this study is to evaluate KarXT + KarX-EC as a treatment for psychosis associated with Alzheimer's disease.

Key Dates

Start date
Mar 25, 2026
Status verified
Jun 2026
Primary completion
Feb 21, 2028
Completion
Mar 20, 2028

Study Design

Enrollment
325 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Placebo
  • Experimental: KarXT + KarX-EC Arm

Primary Outcome Measure

Change From Baseline in Neuropsychiatric Inventory-Clinician: Hallucinations and Delusions (NPI-C: H+D) Score [ Time Frame: Up to approximately Week 14 ]

Central Contacts

  • BMS Clinical Trials Contact Center www.BMSClinicalTrials.com, www.BMSStudyConnect.com
    855-907-3286
    [email protected]
  • First line of the email MUST contain NCT # and Site #.

Locations (6)

FacilityCityStateZIPSite coordinators
Gilbert Neurology Partners/CCT ResearchGilbertArizona85297
Jonathan Hodgson, Site 0042
602-761-9631
Inland Psychiatric Medical Group.ChinoCalifornia91710
Nandita Puchakayala, Site 0031
909-488-9116
Local Institution - 0001NaplesFlorida34105-
Local Institution - 1401NaplesFlorida34105
Site 1401
Local Institution - 0029ClevelandOhio44195
Site 0029
Local Institution - 0043Shaker HeightsOhio44122-5288
Site 0043

Find similar trials in Gilbert, AZ

By condition
Alzheimer's disease
By specialty
NeurologyDementia careBrain disordersGeriatrics
By research site
Gilbert Neurology Partners/CCT Research· Gilbert, AZInland Psychiatric Medical Group.· Chino, CALocal Institution - 0001· Naples, FLLocal Institution - 1401· Naples, FLLocal Institution - 0029· Cleveland, OHLocal Institution - 0043· Shaker Heights, OH

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