Active not recruitingPHASE2INTERVENTIONAL

Study to Evaluate the Efficacy, Safety, and Tolerability of an Anti-MTBR Tau Monoclonal Antibody (BMS-986446) in Participants With Early Alzheimer's Disease

This research study is investigating a new experimental medicine, BMS-986446, for individuals who have been diagnosed with early Alzheimer's disease. Alzheimer's affects memory and thinking, and this study aims to understand if the new medication could be a helpful treatment. We want to find out how well it works (its effectiveness), if it causes any unwanted side effects (its safety), and if people tolerate taking it well. Participants will either receive the new medication or a 'dummy' treatment (placebo) to help researchers compare the results fairly. This is an important step in developing potential new ways to manage or slow down the progression of early Alzheimer's disease, offering hope for future treatments.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

Bristol-Myers Squibb

Enrolment target

310

Start

20 Mar 2024

Estimated completion

18 Mar 2027

Alzheimer Disease, Early Onset

What is this study about?

This research is looking into a new medication called BMS-986446, which is an 'Anti-MTBR Tau Monoclonal Antibody'. Don't worry too much about the scientific name, but the idea is that this medication targets specific proteins in the brain that are thought to be involved in Alzheimer's disease. By targeting these proteins, researchers hope it might help slow down or manage the changes that happen in the brain with early Alzheimer's.

We know that Alzheimer's disease can be incredibly challenging for individuals and their families. Finding new and better treatments is a big priority. This study is an important step in understanding whether this new medication could be a useful option in the future. It's currently in an early stage of testing (Phase 2), which means we're carefully checking how it works and whether it's safe for people.

The goal is to see if BMS-986446 can help people with early Alzheimer's disease maintain their memory and thinking abilities, and to make sure that any benefits outweigh potential side effects. Participants will be closely monitored throughout the study to gather all this vital information.

Key takeaways

This study tests a new medication (BMS-986446) for early Alzheimer's disease.
It aims to check if the medicine is effective, safe, and well-tolerated.
Participants will receive either the new medicine or a placebo.
Regular health checks, memory tests, and brain scans will be part of the study.
The study looks for adults aged 50-80 with early-stage Alzheimer's.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To be able to take part in this study, doctors will first need to confirm you have early Alzheimer's disease. This includes having mild memory or thinking problems related to Alzheimer's, and doctors will look for specific signs of Alzheimer's in your brain scans or other tests.

You would also need to show some difficulty with your memory during special tests. Your overall thinking abilities, specifically as measured by a common test called the 'Mini Mental State Exam' (MMSE), would need to be within a certain range, generally between 20 and 28. Participants typically need to be between 50 and 80 years old.

There are also some reasons why you might not be able to join. For example, if you have other medical conditions that could affect your thinking, or if you can't have certain scans (like MRI or PET scans) for medical reasons. They would also check if you have any serious existing health issues or significant depression that might make the study unsafe for you or make it difficult to get clear results.

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.

Have you been diagnosed with early Alzheimer's disease?
Are you between 50 and 80 years old?
Do you have mild memory or thinking problems?
Are you generally able to attend regular clinic appointments and have scans?
Do you have any other serious medical conditions that might affect your thinking?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive either the new medication, BMS-986446, or a placebo (which looks the same but contains no active medicine). Neither you nor your study doctor would know which one you are receiving – this helps ensure the study results are fair and unbiased. The medication would likely be given as an infusion (through a drip into your arm) on a regular schedule.

Throughout the study, you would have regular visits to the clinic. These visits would involve several assessments to check your memory and thinking, review any side effects you might be experiencing, and confirm your general health. You would also have blood tests and regular brain scans (such as MRI and PET scans) to monitor your brain health. The exact number of visits and the full duration of the study would be explained to you in detail by the study team, but research studies like this can often last for many months to a couple of years.

Potential risks and benefits

Taking part in a clinical study can offer potential benefits, such as contributing to scientific understanding of Alzheimer's and helping to develop new treatments that could one day benefit others. You would also receive close medical attention and monitoring throughout the study. However, there's no guarantee that the new medication will work for you or prevent your condition from getting worse. Like all medications, BMS-986446 may have side effects, which would be explained fully by the study team. Some of the tests, like scans, also carry small risks. It's very important to remember that participating is completely voluntary, and you are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (176)

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

Local Institution - 0068
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Chandler, United States
Local Institution - 0102
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Gilbert, United States
Local Institution - 0019
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Phoenix, United States
Local Institution - 0018
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Scottsdale, United States
Local Institution - 0026
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Scottsdale, United States
Local Institution - 0077
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Tucson, United States
Local Institution - 0038
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Tucson, United States
Local Institution - 0164
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Encino, United States
Local Institution - 0139
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Fullerton, United States
Local Institution - 0191
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Irvine, United States
Local Institution - 0234
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Long Beach, United States
Local Institution - 0142
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Los Alamitos, United States

Common questions

What is Alzheimer's disease?

Alzheimer's disease is a brain condition that gradually causes problems with memory, thinking, and behaviour. It's the most common cause of dementia.

What is a 'placebo'?

A placebo is a 'dummy' treatment that looks just like the real medicine but contains no active ingredients. It's used in studies to see if the new drug actually works better than no treatment at all.

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

No, during the study, neither you nor your study doctor will know whether you are receiving the new medicine or the placebo. This helps ensure the study results are fair.

How long will the study last?

The full duration of the study, including how many visits and how long you might be taking the medication, would be explained in detail by the study team if you are suitable to join.

Can I stop participating in the study if I change my mind?

Yes, absolutely. Your participation is voluntary, and you can withdraw from the study at any time, for any reason, without it affecting your medical care.