RecruitingPHASE2INTERVENTIONAL

A Clinical Trial to Learn About the Effects of VHB937 in People With Early Alzheimer's Disease

This study, called "A Clinical Trial to Learn About the Effects of VHB937 in People With Early Alzheimer's Disease," is investigating a new medication, VHB937, for individuals in the early stages of Alzheimer's disease. The main goals are to find out if VHB937 is safe to use and whether it can help improve or slow down changes in memory, thinking skills, and daily activities. Participants will receive either VHB937 or a placebo (a dummy pill with no active ingredient) in a random order, meaning neither they nor their doctor will know which they are getting. This study will last for about 72 weeks, followed by an additional period called an extension study. It's a way for scientists to carefully observe the effects of VHB937 over time.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Novartis Pharmaceuticals

Enrolment target

407

Start

07 Aug 2025

Estimated completion

31 Dec 2030

Alzheimer's Disease

What is this study about?

This important study is designed to explore whether a new medicine, VHB937, could be helpful for people living with early Alzheimer's disease. Alzheimer's is a complex condition, and finding treatments that can make a real difference is a key focus for researchers. This trial aims to gather detailed information about VHB937, including how safe it is to use and if it has any positive effects on memory, thinking skills, and the ability to carry out everyday tasks.

Researchers will also be looking closely at how the body handles VHB937 and if it influences changes in the brain that are linked to Alzheimer's. By understanding these aspects, doctors can better assess the potential of VHB937 as a future treatment option.

The study involves comparing VHB937 with a placebo, which looks exactly like the study medicine but doesn't contain any active drug. This helps researchers understand whether any changes seen in participants are truly due to VHB937 or if they might happen naturally or due to other factors. Each participant will be carefully monitored throughout the study to ensure their well-being and to collect all the necessary information.

Key takeaways

Exploring a new medicine, VHB937, for early Alzheimer's disease.
Aims to check if VHB937 is safe and helps with memory and thinking.
Compares VHB937 to a placebo (dummy pill).
Requires regular clinic visits and the support of a study partner.
Participation helps advance understanding of Alzheimer's.
You can withdraw from the study at any time.

Who may be eligible?

To join this study, you would generally need to be between 50 and 85 years old. Doctors would confirm that you are in the early stages of Alzheimer's disease, or have 'Mild Cognitive Impairment' (MCI) that is thought to be due to Alzheimer's. This often means your memory or thinking might be a bit different, but you can still manage most daily activities.

An important part of joining is having a trusted family member or friend who can come with you to appointments and help answer questions about your daily life. Doctors will also check for specific signs of Alzheimer's in your brain using tests like spinal fluid analysis or special scans.

Certain health conditions or previous medical events, such as heart problems, strokes in the last year, or uncontrolled serious illnesses like cancer or diabetes, would mean you couldn't take part. Also, if you have other types of dementia or serious mental health conditions, this study might not be suitable for you.

Quick self-check

Are you between 50 and 85 years old?
Have doctors diagnosed you with early Alzheimer's or mild cognitive impairment (MCI) thought to be due to Alzheimer's?
Do you have a trusted family member or friend who can go with you to study appointments and answer questions?
Do you have any serious heart conditions, recent strokes, or uncontrolled major illnesses like cancer or diabetes?
Do you have other types of dementia or serious mental health conditions?
Are you willing and able to attend regular clinic visits over a long period?

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

What does participation involve?

Taking part in this study would involve a series of regular visits to a clinic over about 72 weeks (roughly one and a half years), followed by a possible extension period. During these visits, you would have medical check-ups, assessments of your memory and thinking skills, and discussions about your daily activities. You would receive either the study medicine, VHB937, or a placebo (a dummy pill) which you would take regularly as instructed. Neither you nor your study doctor would know which one you are receiving – this is decided randomly. You would also have blood tests and possibly other tests, like brain scans or spinal fluid tests, to monitor your health and the effects of the treatment. A study partner is also required to attend visits with you.

Potential risks and benefits

Participating in research studies like this can offer several potential benefits. You would receive close medical monitoring and access to a potential new treatment that isn't yet widely available. Your involvement also helps further medical understanding of Alzheimer's disease, which could help many others in the future. However, there are also potential risks; VHB937 is an experimental medicine, and like all medications, it could have side effects that are currently unknown or unexpected. You might experience discomfort from tests like blood samples or scans. Importantly, you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (65)

Banner Alzheimers Institute
Phoenix, United States· Recruiting
Irvine Center for Clinical Research
Irvine, United States· Recruiting
University of California San Diego
La Jolla, United States· Recruiting
University of California at Los Angeles
Los Angeles, United States· Recruiting
Jem Research Institute
Atlantis, United States· Recruiting
Visionary Investigators Network
Aventura, United States· Recruiting
K2 Medical Research LLC
Maitland, United States· Recruiting
K2 Medical Research LLC
Maitland, United States· Recruiting
Renstar Medical Research
Ocala, United States· Recruiting
Charter Research The Villages
The Villages, United States· Recruiting
Alzheimers Research Treatment Ctr
Wellington, United States· Recruiting
Alzheimers Research Treatment Ctr
Wellington, United States· Recruiting

+53 more sites — see the official record for the full list.

Common questions

What is Alzheimer's disease?

Alzheimer's disease is a brain condition that gradually affects memory, thinking skills, and the ability to carry out daily tasks. It's the most common cause of dementia.

What does 'early Alzheimer's disease' mean?

This refers to the stage where memory and thinking problems are mild, often described as Mild Cognitive Impairment (MCI) due to Alzheimer's, or very mild Alzheimer's dementia. People can usually still manage most daily activities.

What is a 'placebo'?

A placebo is a dummy pill or treatment that looks exactly like the study medicine but has no active ingredient. It's used to compare against the real medicine to see if the medicine itself is causing any effects.

Who is a 'study partner'?

A study partner is a close family member or friend who knows you well, spends at least 8 hours a week with you, and can attend study visits to help answer questions about your memory and daily life.

Can I stop participating in the study at any time?

Yes, absolutely. Your participation is completely voluntary, and you can choose to leave the study at any point without it affecting your medical care.

How to find out more

Novartis Pharmaceuticals

novartis.email@novartis.com 1-888-669-6682 Official trial record

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