RecruitingOBSERVATIONAL

Longitudinal Early-onset Alzheimer's Disease Study Protocol

This study, called LEADS, aims to understand how early-onset Alzheimer's disease changes over several years. It includes people diagnosed with early Alzheimer's, those with other memory issues, and healthy volunteers, all aged 40 to 64. Researchers will collect various health details, including memory tests, brain scans, and blood samples, to learn more about the condition's progression. This information could lead to better ways to diagnose and treat early-onset Alzheimer's in the future. Importantly, this is an observational study, meaning participants won't receive new treatments as part of the research itself.

At a glance

Status

Recruiting

Sponsor

Indiana University

Enrolment target

850

Start

30 Apr 2018

Estimated completion

31 May 2026

Early Onset Alzheimer Disease Alzheimer Disease Mild Cognitive Impairment

What is this study about?

The "LEADS" study is looking into early-onset Alzheimer's disease, which affects people younger than usual. The main goal is to understand how this condition progresses over time. Researchers will closely follow individuals with early Alzheimer's, those with other memory problems, and healthy people aged 40 to 64 years.

This study is like observing a natural journey – no new medicines or treatments are given as part of the research. Instead, the team will collect a lot of information, including how memory and thinking skills change, what brain scans show, and looking at blood or other samples. This will help them see how these different aspects are connected and how the disease develops.

By gathering all this detail, the researchers hope to build a clearer picture of early-onset Alzheimer's. This knowledge is really important because it could help doctors diagnose the condition earlier, understand it better, and eventually lead to new and more effective ways to help people living with it.

Key takeaways

Study focuses on understanding early-onset Alzheimer's.
No new medications are given; it's an observational study.
Open to people aged 40-64 with or without memory problems.
Involves memory tests, brain scans, blood tests, and optional spinal fluid tests.
A 'study partner' is usually required to help provide information.
Participation helps future understanding and potential treatments.

Who may be eligible?

To join the study, you'd generally need to be between 40 and 64 years old. If you have memory or thinking problems, you might be eligible if a doctor has diagnosed you with mild Alzheimer's or a similar condition that affects your thinking.

If you don't have memory problems, you could join as a healthy volunteer if you have no significant memory issues. For all participants, a study partner (like a family member or close friend) who spends at least 10 hours a week with you and knows about your daily life would generally be needed.

Also, you would need to be able to understand and agree to take part in the study yourself, or have someone legally able to make decisions for you. There are a few other specific health requirements, and women who could become pregnant might need to take a pregnancy test before certain procedures.

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 40 and 64 years old?
If you have memory concerns, have you been told you might have early Alzheimer's or similar problems?
Do you have a family member or close friend who spends at least 10 hours a week with you?
Are you able to agree to take part in the study yourself?
Are you willing to have regular memory tests and brain scans?

Answer every question to see your result.

What does participation involve?

If you take part in this study, you won't be given any new medications. It's about observing how things change naturally. What you do will depend on whether you have memory problems or are a healthy volunteer.

If you have memory or thinking problems, you'll be part of the study for at least four years. If you're a healthy volunteer, you'll take part for at least two years. During this time, you'll have regular hospital or clinic visits. At these visits, you'll do memory and thinking tests, and some of them will be on a computer. You'll also have special brain scans called PET and MRI scans, and blood tests.

There's also an option to have a lumbar puncture (spinal tap) to collect a small fluid sample from your spine, and you might be asked to consider donating your brain for research after your death. Your study partner will also be asked questions about your daily activities and memory.

Potential risks and benefits

Taking part in any study has potential benefits and risks. A benefit here is contributing to a better understanding of early-onset Alzheimer's disease, which could help future patients. You would also receive detailed assessments of your health, brain, and thinking skills. Regarding risks, some procedures, like blood tests or scans, involve minor discomfort or very small risks, similar to routine medical checks. The optional lumbar puncture carries a small risk of headache. You have the full right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (23)

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

Banner Sun Health Research Institute
Verified postcode
Sun City, United States· Completed
University of California, Los Angeles
Verified postcode
Los Angeles, United States· Recruiting
Stanford University
Verified postcode
Palo Alto, United States· Recruiting
University of California, San Francisco
Verified postcode
San Francisco, United States· Recruiting
Georgetown University
Verified postcode
Washington D.C., United States· Completed
Mayo Clinic, Jacksonville
Verified postcode
Jacksonville, United States· Recruiting
Wien Center
Verified postcode
Miami Beach, United States· Completed
Emory University
Verified postcode
Atlanta, United States· Recruiting
Northwestern University
Verified postcode
Chicago, United States· Completed
Indiana University
Verified postcode
Indianapolis, United States· Recruiting
Johns Hopkins University
Verified postcode
Baltimore, United States· Recruiting
Massachusetts General Hospital
Verified postcode
Boston, United States· Recruiting

Common questions

What is early-onset Alzheimer's disease?

It's a form of Alzheimer's that affects people younger than 65, usually between 30 and 60 years old.

Will I receive any new treatment in this study?

No, this study is about observing the disease's progression, not testing new treatments.

How long will I need to be in the study?

If you have memory problems, it's at least four years. If you're a healthy volunteer, it's at least two years.

What kind of tests will I have?

You'll have memory and thinking tests, brain scans (PET and MRI), blood tests, and potentially a spinal fluid test.

Do I need someone to come with me?

Yes, you generally need a 'study partner' who knows you well and spends time with you.

How to find out more

IU LEADS Team

iuleads@iupui.edu 317-963-7436 Official trial record

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