Active not recruitingPHASE3INTERVENTIONAL

A Study to Confirm Safety and Efficacy of Lecanemab in Participants With Early Alzheimer's Disease

This study, called a Phase 3 trial, is looking at a new medicine called lecanemab for people with early Alzheimer's disease. The main goal is to find out if lecanemab is better than a dummy treatment (placebo) at slowing down the changes in memory and thinking that happen with Alzheimer's. They will study this over 18 months. After the main part, there's a longer-term 'extension phase' to check how safe lecanemab is over a longer period and if its benefits continue. This part also ensures people can still get the medicine if it's not widely available yet. Participants will receive the medicine either through a drip into a vein or an injection under the skin.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Eisai Inc.

Enrolment target

1,906

Start

27 Mar 2019

Estimated completion

30 Jun 2029

Early Alzheimer's Disease

What is this study about?

This study is investigating a new medication called lecanemab for people who are in the early stages of Alzheimer's disease. Alzheimer's is a condition that affects memory and thinking skills. The researchers want to understand two main things about lecanemab: firstly, if it's safe for people to take, and secondly, if it can help slow down the progression of memory and thinking problems compared to not taking any active treatment (a 'placebo'). This is a really important step in developing new treatments for Alzheimer's.

The main part of the study will last for 18 months, where doctors will closely monitor participants' memory and thinking using a special rating scale. After this initial period, many participants will have the option to continue in an 'extension phase'. This longer phase helps researchers see if the benefits of lecanemab last over time and if there are any long-term effects. It also ensures that people in countries where the medicine isn't yet available can continue to receive it if they benefited from it.

Participants will receive lecanemab either through a drip into a vein (known as intravenous or IV) or as an injection just under the skin (subcutaneous or SC). Sometimes, if approved, these treatments might even be given at home. This study is crucial for gathering more information about lecanemab, which could potentially offer a new way to help people living with early Alzheimer's disease.

Key takeaways

This study is testing a new medicine called lecanemab for early Alzheimer's disease.
It aims to see if lecanemab is safe and can slow down memory and thinking changes.
Participants will receive the medicine via a drip or an injection.
The study includes a main 18-month phase and a longer-term extension.
You might receive the active medicine or a dummy treatment (placebo) initially.

Who may be eligible?

To be considered for this study, you would generally need to be diagnosed with early Alzheimer's disease. This means either having mild memory and thinking problems (known as Mild Cognitive Impairment due to Alzheimer's) or mild Alzheimer's disease itself. Doctors will use specific tests and criteria to make sure you fit into one of these categories. You would need to have had memory problems develop slowly over the last year, and a family member or close friend would need to confirm this.

Other important requirements include being between 50 and 90 years old. Your memory would need to show some impairment on specific tests. Also, tests would need to confirm that you have certain markers in your brain linked to Alzheimer's. Your general mental sharpness, measured by a quick test, would need to be within a certain range.

You should also have a body mass index (a measure of weight relating to height) between 17 and 35. If you are already taking other approved Alzheimer's medicines, like those for memory, you would need to be on a stable dose for at least 12 weeks before starting. However, people who haven't taken any Alzheimer's medicine before can also join the study.

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.

Do I have a diagnosis of early Alzheimer's disease or mild cognitive impairment due to Alzheimer's?
Am I between 50 and 90 years old?
Have I had memory problems that started slowly and got worse over the last year?
Have I had tests that show markers for Alzheimer's in my brain?
Am I generally healthy enough to participate in a clinical study?

Answer every question to see your result.

What does participation involve?

If you join this study, you will have regular visits to the clinic, or potentially receive some treatments at home if allowed. During these visits, doctors and nurses will carry out various assessments to check your memory and thinking, as well as your general health. You will receive the study medicine, lecanemab, either through a drip into your vein (IV) or as an injection under your skin (SC), depending on which form is being tested for you.

These treatments will be given regularly over an 18-month period for the main part of the study. After this, if you choose, you can continue in a longer 'extension phase', where you would keep receiving the medicine and having check-ups. The total duration of your involvement could be several years if you join the extension phase. The research team will explain the exact schedule of visits and what each check-up involves.

Potential risks and benefits

Taking part in any study has potential benefits and risks. A potential benefit of joining this study is that you might receive lecanemab, which could help slow down the changes in your memory and thinking associated with early Alzheimer's disease. You would also receive regular medical check-ups and contribute to valuable research that could help others in the future. Potential risks include side effects from the medication, which the research team will explain in detail. There might also be side effects from the procedures, like having blood tests. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (247)

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

Banner Alzheimer's Institute- Clinical Trials Department
Verified postcode
Phoenix, United States
Banner Sun Health Research
Verified postcode
Sun City, United States
Neurological Associates of Tucson dba Center for Neurosciences
Verified postcode
Tucson, United States
Neurology Center of North Orange County
Verified postcode
Fullerton, United States
Irvine Clinical Research
Verified postcode
Irvine, United States
University of California - Los Angeles
Verified postcode
Los Angeles, United States
Pacific Neuroscience Medical Group
Verified postcode
Oxnard, United States
Stanford University Medical Center
Verified postcode
Palo Alto, United States
Pacific Research Network, Inc
Verified postcode
San Diego, United States
Sharp Mesa Vista Hospital
Verified postcode
San Diego, United States
UCSF Memory and Aging Center
Verified postcode
San Francisco, United States
Apex Research Institute
Verified postcode
Santa Ana, United States

Common questions

What is lecanemab?

Lecanemab is a new medicine being tested to see if it can help slow down the progression of early Alzheimer's disease.

What is 'early Alzheimer's disease'?

This refers to people who have mild memory and thinking problems due to Alzheimer's, or who are in the very early stages of Alzheimer's disease.

Will I definitely get the active medicine?

In the main part of the study, some people will get lecanemab and others will get a 'placebo', which is a dummy treatment, so researchers can compare them fairly.

How will I receive the medicine?

You will receive the medicine either through a drip into a vein (IV infusion) or as an injection under your skin (SC injection).

How long does the study last?

The main part of the study is 18 months, but there's an option to continue in a longer-term 'extension phase' for several more years.