Actively Recruiting
A Study to Evaluate Safety and Efficacy of KarXT + KarX-EC as a Treatment for Psychosis Associated With Alzheimer's Disease (ADEPT-5)
Led by Bristol-Myers Squibb · Updated on 2026-05-11
325
Participants Needed
22
Research Sites
103 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to evaluate KarXT + KarX-EC as a treatment for psychosis associated with Alzheimer's disease.
CONDITIONS
Official 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 had a brain MRI or CT scan within the past 5 years to rule out other CNS diseases
- Have a history of psychotic symptoms meeting International Psychogeriatric Association criteria for at least 2 months prior to screening
You will not qualify if you...
- Psychotic symptoms primarily due to conditions other than Alzheimer's disease, such as schizophrenia or mood disorders with psychotic features
- History of major depressive episode with psychotic features within 12 months prior to screening
- History of bipolar disorder, schizophrenia, or schizoaffective disorder
- Certain safety concerns including irregular laboratory tests
- Other protocol-defined exclusion criteria apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 22 locations
1
Local Institution - 0042
Gilbert, Arizona, United States, 85297
Not Yet 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Withdrawn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
CONTACT
F
First line of the email MUST contain NCT # and Site #.
CONTACT
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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