Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

I9X-MC-MTAE: Assessment of Safety, Tolerability, and Efficacy of LY3372689 in Early Symptomatic Alzheimer’s Disease

This research study is for people who have early signs of Alzheimer's disease. It's investigating a new experimental medicine, LY3372689, to understand if it's safe to use, what side effects it might cause, and if it can help with the symptoms of the disease. Participants will either receive the new medication or a placebo, which is a dummy treatment that looks just like the real medicine but contains no active ingredient. This is a common way to test new drugs to see if they work better than nothing at all. The study aims to measure changes in a scale that assesses daily activities and memory over time, to see if the treatment makes a difference. Anyone aged 18 or over, male or female, might be able to take part.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Eli Lilly & Co.

Enrolment target

Start

26 Nov 2024

Alzheimer Disease

What is this study about?

This study is exploring a new treatment option called LY3372689 for people in the early stages of Alzheimer's disease. Alzheimer's is a condition that affects memory, thinking, and behaviour, and it gradually worsens over time. Finding effective treatments is very important to help people live better with the condition.

The main goals of this study are to find out if the new medication is safe for people to take and what side effects it might have. Researchers also want to see if it can help improve daily life and memory for those with early Alzheimer's. This type of study, called a Phase II trial, is a crucial step in developing new medicines, as it helps determine if a drug shows enough promise to be studied in even larger groups of people.

Participants in the study will be compared to a group receiving a "placebo." A placebo is an inactive substance designed to look exactly like the real medication. This comparison is vital to ensure that any improvements seen are genuinely due to the new medication and not just other factors. By carefully monitoring participants and their symptoms over time, researchers hope to gain valuable insights into the potential of LY3372689 to make a real difference for people with Alzheimer's disease.

Key takeaways

This study is for early Alzheimer's disease.
It tests a new medication called LY3372689.
It aims to check safety, side effects, and if it helps symptoms.
Some participants will receive a dummy treatment (placebo).
It's open to adults aged 18 and over.
Participation involves regular clinic visits and health checks.

Who may be eligible?

This study is open to adults aged 18 years and older, regardless of whether they are male or female. To be considered for this study, you must have been diagnosed with early symptoms of Alzheimer's disease.

The research team will need to check your medical history and conduct some tests to make sure the study is a safe and suitable option for you. They will look for specific signs and symptoms of early Alzheimer's and ensure you don't have other health conditions that might make taking part risky or affect the study results.

Quick self-check

Are you 18 years old or older?
Have you been diagnosed with early Alzheimer's disease?
Are you able to attend regular clinic appointments?
Are you willing to take a study medication or a placebo?

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

What does participation involve?

If you join this study, your journey will involve a number of visits to the clinic over a set period. These visits will include checks of your health, discussions about any symptoms you're experiencing, and memory or thinking tests to track your progress.

You will be given either the new study medication, LY3372689, or a placebo (a dummy treatment) to take regularly, as instructed by the study team. Some tests, like blood tests, might be needed periodically. The study team will explain exactly what's involved in each visit and how often you'll need to attend. The total duration of your participation in the study, from your first visit to your last follow-up, will be clearly outlined to you before you agree to take part.

Potential risks and benefits

Taking part in a clinical trial offers potential benefits, such as contributing to scientific understanding of Alzheimer's and possibly helping others in the future. You might also gain access to a new experimental medication before it's widely available. However, there are potential risks, including side effects from the study medication, which might be mild or more serious. There's also no guarantee the treatment will work for you, and you could receive a placebo. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

—
Poland

Common questions

What is a 'placebo'?

A placebo is a dummy treatment that looks exactly like the real medication but doesn't contain any active ingredients. It's used to compare against the real drug to see if the new medicine works.

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

No, during the study, neither you nor the study doctors will know whether you are receiving the active medication or the placebo. This helps ensure the study results are accurate.

Who can take part in this study?

Anyone aged 18 or over, male or female, who has been diagnosed with early symptoms of Alzheimer's disease may be eligible to participate.

What kind of tests will I have?

You will likely have health checks, memory and thinking tests, and possibly blood tests at different points during the study.

Can I stop participating if I change my mind?

Yes, you can choose to leave the study at any time, for any reason, and it will not affect your usual medical care.