RecruitingOBSERVATIONAL

Development of a Database to Investigate Digital and Blood-Based Biomarkers and Their Relationship to Tau and Amyloid PET Imaging in Older Participants Who Are Cognitively Normal (CN), Have Mild Cognitive Impairment (MCI), or Have Mild-to-Moderate AD Dementia

This study, called Bio-Hermes-002, is designed to gather lots of information from older adults to better understand Alzheimer's disease. Researchers will collect blood samples, do brain scans (MRI and PET scans), and gather digital information like how people use their phones or computers. The main goal is to see if these new digital and blood tests can accurately show changes in the brain related to Alzheimer's, specifically looking at proteins called tau and amyloid. This could help doctors find the disease earlier, potentially leading to better treatments in the future for people with normal memory, mild memory issues, or early Alzheimer's.

At a glance

Status

Recruiting

Sponsor

GAP Innovations, PBC

Enrolment target

1,200

Start

26 Sep 2024

Estimated completion

01 Jul 2028

Mild Cognitive Impairment Alzheimer's Disease Alzheimer's Disease, Early Onset Memory Loss Memory Disorders Memory Impairment

What is this study about?

This research, called Bio-Hermes-002, is an important study aiming to find better ways to detect Alzheimer's disease. Currently, diagnosing Alzheimer's can involve complex memory tests and sometimes expensive brain scans. This study hopes to discover if simpler methods, like blood tests or even looking at how people use digital devices, can give us clues about what's happening in the brain. They are particularly interested in two proteins, tau and amyloid, which are known to build up in the brains of people with Alzheimer's.

Imagine if a simple blood test could tell you if you're at risk or showing early signs of Alzheimer's – that's the kind of future this research is working towards. They will collect a wide range of data, from detailed brain images to blood samples and even information from everyday digital activities. This huge collection of data will help scientists compare these new tests with established brain scans to see if they match up.

By comparing these different types of information, the researchers want to see if digital and blood measurements can accurately show changes in the brain related to tau and amyloid proteins. This could eventually lead to earlier and simpler ways to diagnose Alzheimer's, which is crucial for starting potential treatments sooner and improving people's lives.

Key takeaways

Aims to find simpler ways to detect Alzheimer's disease early.
No new medications are given; it's an observational study.
Involves blood tests, brain scans (MRI and PET), and gathering digital information.
Requires a study partner who knows you well.
Participation lasts around 4 months (120 days).

Who may be eligible?

This study is looking for volunteers between 60 and 90 years old. To take part, you'll need to have a "study partner" – someone who spends at least 8 hours a week with you and can accurately talk about your memory and daily abilities. This person could be a family member or close friend.

You'll also need to be willing to undergo different medical tests, including MRI and PET brain scans, and give blood samples. It's important that you can understand and speak the language used for the study tests at the research centre. Finally, you should also have a specific score on a memory test called the Mini-Mental State Exam (MMSE), which will be checked during your first visit.

There are also some reasons why you might not be able to join. For example, if you are pregnant, have certain allergies to materials used in scans, or have medical reasons that prevent you from having brain scans, you wouldn't be able to take part.

Quick self-check

Are you between 60 and 90 years old?
Do you have a study partner who sees you often (at least 8 hours a week)?
Are you willing to have blood tests and brain scans (MRI and PET)?
Can you speak and understand the language of the study tests?
Did you score between 16 and 30 on your last Mini-Mental State Exam?
Are you interested in helping future research into Alzheimer's disease?

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

What does participation involve?

If you decide to join this study, your participation will last about 120 days (around four months). During this time, you won't be given any new medication as part of the study; instead, the focus is on gathering information.

You'll be asked to come in for several visits where you'll have various assessments. This includes providing blood samples, having MRI and PET brain scans (which look at specific proteins in your brain), and undergo eye examinations. You'll also be asked to let researchers collect data from digital sources, though the exact nature of this is not specified as medication.

All collected samples and data might be stored for future research. After your participation ends, you might be contacted to see if you'd be interested in other clinical research trials.

Potential risks and benefits

Taking part in research like this doesn't offer a direct medical benefit to you right away, but it could help doctors better understand Alzheimer’s disease in the future, potentially leading to new ways to diagnose it earlier. As with any medical procedure, there are some potential risks. These can include minor discomfort or bruising from blood draws, or potential reactions to the small amounts of radioactive material used in some PET scans. The study team will explain all risks in detail and ensure your safety throughout. Remember, you can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (26)

JEM Research Institute
Atlantis, United States· Recruiting
Visionary Investigators Network
Aventura, United States· Recruiting
K2 - Winter Garden
Clermont, United States· Recruiting
Brain Matters Research
Delray Beach, United States· Recruiting
Neuropsychiatric Research Center of SW Florida
Fort Myers, United States· Recruiting
K2 Medical Research
Maitland, United States· Recruiting
Clincloud
Melbourne, United States· Recruiting
Visionary Investigators Network
Miami, United States· Recruiting
Charter Research
Orlando, United States· Recruiting
Progressive Medical Research
Port Orange, United States· Recruiting
Intercoastal Medical Group, Inc.
Sarasota, United States· Recruiting
Axiom Brain Health
Tampa, United States· Recruiting

+14 more sites — see the official record for the full list.

Common questions

What is a 'study partner'?

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

Will I receive any new medicine in this study?

No, this study is about collecting information and samples, not about testing new medications.

What are 'digital biomarkers'?

Digital biomarkers are information gathered from your digital activities (like how you use a smartphone or computer) that might give clues about your health or brain function.

How long will I be in the study?

Your participation in the study will last for about 120 days, which is roughly four months.

Is there any cost to me to participate?

Research studies generally cover the costs of study-related tests and procedures, but you should confirm this with the study team.

How to find out more

Amanda Ng, MA

biohermes-002@globalalzplatform.org biohermes-002@globalalzplatfor Official trial record

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