RecruitingPHASE3INTERVENTIONAL

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

This research study, called ADEPT-5, is investigating a new medication combination, KarXT + KarX-EC, for people with Alzheimer's disease who also experience psychosis. Psychosis can cause symptoms like seeing or hearing things that aren't there, or having strong, unfounded beliefs. The study aims to understand if this new treatment is safe and effective in reducing these symptoms. Participants will be aged between 55 and 90 years old and have a confirmed diagnosis of Alzheimer's. They will also need to have experienced psychotic symptoms for at least two months. This is a Phase 3 trial, meaning it's a later stage of research designed to confirm the treatment's benefits and safety in a larger group of people.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Bristol-Myers Squibb

Enrolment target

325

Start

25 Mar 2026

Estimated completion

20 Mar 2028

Alzheimer Disease Psychosis

What is this study about?

This study is exploring a new treatment for a challenging aspect of Alzheimer's disease: psychosis. Psychosis can be a distressing symptom for people with Alzheimer's, leading to experiences like hallucinations (seeing or hearing things that aren't real) or delusions (strong beliefs that aren't based in reality). Current treatments for psychosis in Alzheimer's can have side effects, so researchers are always looking for safer and more effective options.

The medication being tested is a combination called KarXT + KarX-EC. This study is designed to carefully examine how well this treatment works and whether it is safe for patients. Some participants will receive the active treatment, while others will receive a 'placebo', which looks like the real medication but contains no active drug. This comparison helps researchers understand the true effects of the new treatment.

Finding better ways to manage psychosis in Alzheimer's disease is important because these symptoms can significantly affect a person's quality of life and the well-being of their caregivers. This research aims to contribute to our understanding of potential new therapies that could help improve care for individuals living with both Alzheimer's and psychosis.

Key takeaways

This study is testing a new treatment, KarXT + KarX-EC, for psychosis in Alzheimer's.
It aims to see if the treatment is safe and helps reduce symptoms like hallucinations.
Participants must be between 55 and 90 years old with an Alzheimer's diagnosis and psychosis.
Some participants will receive the active drug, others a placebo.
Your participation is voluntary, and you can withdraw at any time.
The research team will carefully explain all aspects of the study, including potential risks and benefits.

Who may be eligible?

This study is looking for people aged 55 to 90 who have been diagnosed with Alzheimer's disease. You'd also need to have had symptoms of psychosis, such as hallucinations or delusions, for at least two months before the study starts. To make sure Alzheimer's is the correct diagnosis, a brain scan (MRI or CT) would have been done within the last five years, ruling out other brain conditions.

There are also some reasons why you might not be able to join. For example, if your psychotic symptoms are thought to be mainly due to another serious mental health condition like schizophrenia or bipolar disorder, rather than Alzheimer's. Also, if you've had a severe depressive episode with psychotic features in the last year, or have certain abnormal results from blood or other medical tests, you might not be eligible. The research team will go through all the detailed criteria with you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 55 and 90 years old?
Do you have a confirmed diagnosis of Alzheimer's disease?
Have you experienced psychotic symptoms (like hallucinations or delusions) for at least two months?
Has a brain scan (MRI or CT) been done in the last 5 years confirming your diagnosis?
Are your psychotic symptoms believed to be primarily due to Alzheimer's, not another mental health condition?

Answer every question to see your result.

What does participation involve?

Taking part in this study would involve a number of visits to the study clinic over a period of time. During these visits, the research team would carry out different assessments. This would include medical examinations, blood tests, and questionnaires to track your symptoms and how you're feeling. You would also be asked to take the study medication (either KarXT + KarX-EC or a placebo) as instructed. There would be regular check-ups to monitor your health and any side effects. The total length of your involvement in the study, including follow-up, would be fully explained to you before you decide to participate.

Potential risks and benefits

Participating in research always comes with potential benefits and potential risks. A possible benefit might be that the new treatment helps improve your psychotic symptoms. However, it's also possible that the treatment may not work for you, or you might receive the placebo. Like all medicines, KarXT + KarX-EC could have side effects, which the study team will monitor closely and explain thoroughly. You will be given detailed information about all known risks and benefits before deciding to take part. Remember, joining is entirely your choice, and you are free to withdraw from the study at any time without giving a reason, and this would not affect your usual medical care.

Locations (22)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Gilbert Neurology Partners/CCT Research
Verified postcode
Gilbert, United States· Recruiting
Inland Psychiatric Medical Group.
Verified postcode
Chino, United States· Recruiting
Local Institution - 0001
Verified postcode
Naples, United States· Withdrawn
Local Institution - 1401
Verified postcode
Naples, United States· Not yet recruiting
Local Institution - 0029
Verified postcode
Cleveland, United States· Not yet recruiting
Local Institution - 0043
Verified postcode
Shaker Heights, United States· Not yet recruiting
Local Institution - 0020
Verified postcode
Macquarie Park, Australia· Not yet recruiting
Local Institution - 0052
Verified postcode
Nedlands, Australia· Not yet recruiting
Local Institution - 0054
Verified postcode
Toronto, Canada· Not yet recruiting
Local Institution - 0027
Verified postcode
Whitby, Canada· Not yet recruiting
Local Institution - 0025
Verified postcode
Montreal, Canada· Not yet recruiting
Local Institution - 0040
Verified postcode
Suita, Japan· Not yet recruiting

Common questions

What is psychosis?

Psychosis can cause someone to see or hear things that aren't actually there (hallucinations) or hold strong beliefs that aren't based on reality (delusions).

What is a Phase 3 study?

Phase 3 is an advanced stage of research where a new treatment is tested on a larger group of people to confirm its effectiveness and safety before it can be considered for wider use.

Will I know if I'm getting the real medication or a placebo?

No, because this is a 'blinded' study, neither you nor the study doctors will know if you are receiving the active treatment or a placebo. This helps ensure unbiased results.

What are KarXT and KarX-EC?

These are the names of the new medications being tested in this study. They're being investigated as a potential treatment for psychosis in people with Alzheimer's disease.

Can I continue with my other medications?

The study team will review all your current medications to ensure they are compatible with the trial. They will provide clear guidance on what can and cannot be taken during the study.

How to find out more

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com, www.BMSStudyConnect.com

Clinical.Trials@bms.com 855-907-3286 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.