Actively Recruiting
A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for Psychosis Associated with Alzheimer's Disease
Led by Bristol-Myers Squibb · Updated on 2026-06-02
325
Participants Needed
22
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the combination of KarXT and KarX-EC as a treatment for psychosis linked to Alzheimer's disease in adults aged 55 to 90. This Phase 3, randomized, double-blind, placebo-controlled study aims to assess the safety and effectiveness of these drugs in managing symptoms such as hallucinations and delusions related to this condition. Participants will be assigned to receive either the KarXT plus KarX-EC treatment or a matching placebo, with specified doses given on certain days over approximately 14 weeks. The study will monitor changes in neuropsychiatric symptoms, agitation, and caregiver distress, along with safety measures including adverse events and laboratory tests. During the trial, participants will undergo various evaluations such as neuropsychiatric inventories, clinical global impressions, cognitive assessments, and safety monitoring through lab tests, vital signs, and symptom tracking. The primary outcome focuses on changes in hallucinations and delusions up to week 14, with ongoing review of additional cognitive and safety outcomes throughout the study period.
CONDITIONS
Brief Title
A Study to Evaluate Safety and Efficacy of KarXT + KarX-EC as a Treatment for Psychosis Associated With Alzheimer's Disease (ADEPT-5)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must be 55 to 90 years old at screening.
- Diagnosed with Alzheimer's disease according to the 2024 revised criteria.
- Have a brain MRI or CT scan from within the past 5 years to exclude other CNS diseases.
- History of psychotic symptoms meeting specific criteria for at least 2 months before screening.
You will not qualify if you...
- Psychotic symptoms primarily caused by conditions other than Alzheimer's disease, such as schizophrenia or mood disorders.
- History of major depressive episode with psychotic features in the past 12 months.
- History of bipolar disorder, schizophrenia, or schizoaffective disorder.
- Certain safety concerns including specific abnormal laboratory tests.
- Other protocol-defined inclusion/exclusion criteria.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to approximately 14 weeks
Participants receive the study drugs KarXT and KarX-EC or matching placebo as a treatment for psychosis associated with Alzheimer's disease.
Trial Site Locations
Total: 22 locations
1
Gilbert Neurology Partners/CCT Research
Gilbert, Arizona, United States, 85297
Actively Recruiting
2
Inland Psychiatric Medical Group.
Chino, California, United States, 91710
Actively Recruiting
3
Local Institution - 0001
Naples, Florida, United States, 34105
Withdrawn
4
Local Institution - 1401
Naples, Florida, United States, 34105
Not Yet Recruiting
5
Local Institution - 0029
Cleveland, Ohio, United States, 44195
Not Yet Recruiting
6
Local Institution - 0043
Shaker Heights, Ohio, United States, 44122-5288
Not Yet Recruiting
7
Local Institution - 0020
Macquarie Park, New South Wales, Australia, 2113
Not Yet Recruiting
8
Local Institution - 0052
Nedlands, Western Australia, Australia, 6009
Not Yet Recruiting
9
Local Institution - 0054
Toronto, Ontario, Canada, M6J1H4
Not Yet Recruiting
10
Local Institution - 0027
Whitby, Ontario, Canada, L1N 5S9
Not Yet Recruiting
11
Local Institution - 0025
Montreal, Quebec, Canada, H4H 1R3
Not Yet Recruiting
12
Local Institution - 0040
Suita, Osaka, Japan, 565-0871
Not Yet Recruiting
13
Local Institution - 0035
Nankoku-shi, Japan, 783-8505
Not Yet Recruiting
14
Local Institution - 0034
Osaka, Japan, 550-0006
Not Yet Recruiting
15
Local Institution - 0005
Exeter, Devon, United Kingdom, EX12LU
Not Yet Recruiting
16
Local Institution - 0018
Saint Leonards-on-Sea, East Sussex, United Kingdom, TN61HB
Not Yet Recruiting
17
Local Institution - 0023
London, England, United Kingdom, W1G 8TA
Not Yet Recruiting
18
Local Institution - 0015
Oxford, Oxfordshire, United Kingdom, OX3 7JX
Not Yet Recruiting
19
Local Institution - 0009
Chertsey, Surrey, United Kingdom, KT160PZ
Not Yet Recruiting
20
Local Institution - 0017
Sheffield, Yorkshire and the Humber, United Kingdom, S47QQ
Not Yet Recruiting
21
Local Institution - 0024
London, United Kingdom, WC1N3BG
Not Yet Recruiting
22
Local Institution - 0004
Motherwell, United Kingdom, ML1 4UF
Not Yet Recruiting
Research Team
B
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com, www.BMSStudyConnect.com
F
First line of the email MUST contain NCT # and Site #.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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