RecruitingPHASE3INTERVENTIONAL

A Study to Evaluate the Efficacy and Safety of KarXT + KarX-EC for Cognitive Impairment in Alzheimer's Disease (MINDSET 2)

This study, called MINDSET 2, is investigating a new medication combination, KarXT + KarX-EC, for individuals living with mild to moderate Alzheimer's disease. The main goal is to determine how well this new treatment works to help with memory and thinking problems (known as cognitive impairment) and to make sure it's safe for patients. Some participants will receive the new treatment, while others will receive a placebo (a dummy treatment with no active medicine) to compare the effects. This is a Phase 3 study, meaning it's one of the final steps before a medicine might become widely available, if it proves both effective and safe.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Bristol-Myers Squibb

Enrolment target

586

Start

21 Jul 2025

Estimated completion

23 Feb 2029

Alzheimer's Disease

What is this study about?

This research study, known as MINDSET 2, is focused on exploring a new way to help people with Alzheimer's disease who are experiencing challenges with their memory and thinking. Alzheimer's is a common condition that affects the brain, causing problems with memory, thinking, and daily activities.

The study is testing a new treatment which is a combination of two medications, KarXT and KarX-EC. The aim is to see if this combination can make a real difference in improving how well people think and remember things. To do this, some people in the study will receive the new treatment, while others will be given a placebo – this looks exactly like the real medicine but contains no active ingredients. This helps the researchers understand if any changes are due to the medication itself or other factors.

Finding new ways to manage Alzheimer's is very important. Studies like MINDSET 2 help us learn more about potential treatments, and whether they are both effective and safe for people. The information gathered from studies like this contributes to the development of new medicines that could help many individuals and families affected by Alzheimer's in the future.

Key takeaways

This study is testing a new treatment (KarXT + KarX-EC) for mild to moderate Alzheimer's.
It aims to see if the treatment helps with memory and thinking, and if it's safe.
Participants will receive either the new treatment or a placebo.
A dedicated caregiver is required to support participants throughout the study.
The study is for people aged 60 to 85.
Participation involves regular clinic visits and taking study medication.

Who may be eligible?

To be considered for this study, you would need to have been diagnosed with mild or moderate Alzheimer's disease. Your memory and thinking abilities, as assessed by a specific test, should fall within a certain range.

A really important part of this study is having a dedicated caregiver. This person would need to spend at least 10 hours a week with you, be willing to come to all study appointments, help make sure you take your medication, and report on how you're doing. They also need to agree to be part of the study process.

There are also some reasons why you might not be able to join. For example, if you have certain serious medical conditions affecting your liver or kidneys, or certain heart problems. If you have been diagnosed with other significant mental health conditions like major depression or bipolar disorder, or a history of schizophrenia, you would also not be able to take part.

Quick self-check

Do you have a diagnosis of mild or moderate Alzheimer's disease?
Are you between 60 and 85 years old?
Do you have a reliable caregiver who can help you with the study?
Are you able to attend regular study appointments?
Do you not have any major heart, liver, or kidney problems?
Have you not been diagnosed with certain other serious mental health conditions?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, you would come for regular appointments at a study clinic. During these visits, the study team would check your health, ask about how you're feeling, and carry out tests to assess your memory and thinking. You would also be asked to take the study medication (either the new treatment or a placebo) regularly as instructed.

Your caregiver would play a key role, attending appointments with you, helping you remember to take your medication, and sharing observations about your health and daily life with the study team. They will be an important source of information on how you are getting on. The total length of time you would be involved in the study would be explained to you by the research team.

Potential risks and benefits

Participating in research studies means there's a chance you might experience some benefits, such as receiving close medical attention and potentially gaining access to a new treatment before it's widely available. However, there's no guarantee the treatment will work for you, and you might receive a placebo. There are also potential risks, such as experiencing side effects from the medication, even if they are mild. The study team will explain all known potential side effects. Remember, joining a study is always your choice, and you are free to withdraw at any time without affecting your medical care.

Locations (124)

Fullerton Neurology and Headache Center
Fullerton, United States· Recruiting
Inglewood Clinical
Inglewood, United States· Recruiting
Irvine Clinical Research
Irvine, United States· Recruiting
Local Institution - 0083
Palo Alto, United States· Not yet recruiting
Local Institution - 0069
San Diego, United States· Withdrawn
Research of the Rockies
Colorado Springs, United States· Recruiting
Neuropsychiatric Research Center of Southwest Florida
Fort Myers, United States· Recruiting
Velocity Clinical Research, Hallandale Beach
Hallandale, United States· Recruiting
Jacksonville Center for Clinical Research
Jacksonville, United States· Recruiting
K2 MEDICAL Research THE VILLAGES
Lady Lake, United States· Recruiting
Intercoastal Medical Group
Sarasota, United States· Recruiting
USF Health Byrd Alzheimer's Institute
Tampa, United States· Recruiting

+112 more sites — see the official record for the full list.

Common questions

What is Alzheimer's disease?

Alzheimer's disease is a common condition that causes problems with memory, thinking, and behaviour, and it usually gets worse over time.

What is a 'placebo'?

A placebo is a 'dummy' treatment that looks just like the real medicine but doesn't contain any active ingredients. It helps researchers compare effects.

Who is eligible to participate?

People with mild to moderate Alzheimer's disease, aged 60-85, with a dedicated caregiver, might be eligible. Other health factors are also considered.

Why is a caregiver needed for this study?

Your caregiver will help you with appointments, medication, and provide important information to the study team about your progress and well-being.

What if I'm already taking Alzheimer's medication?

If you're on certain Alzheimer's medicines, you'd likely need to have been on a stable dose for at least 12 weeks before joining and continue that stable dose during the study.

How to find out more

BMS Clinical Trials Contact Center www.BMSClinicalTrials.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.