Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

I5T-MC-AACI: Assessment of Safety, Tolerability, and Efficacy of Donanemab in Early Symptomatic Alzheimer's Disease

The I5T-MC-AACI study is investigating an experimental treatment called Donanemab for individuals who have early symptoms of Alzheimer's disease. The main goals are to understand if the medicine is safe to use and if people can tolerate it without too many side effects. Researchers will also be looking closely at whether Donanemab helps to improve or slow down changes in a person's daily abilities and memory, using a special rating scale called the Integrated Alzheimer's Disease Rating Scale (iADRS). This is a Phase II study, meaning it’s a crucial step in testing new treatments to see if they are promising enough to study in larger groups of people. It helps us learn more about potential new ways to manage Alzheimer's disease.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Eli Lilly & Co.

Enrolment target

224

Start

01 Oct 2024

Alzheimer Disease

What is this study about?

This study, with the scientific name I5T-MC-AACI, is designed to learn more about a potential new medicine called Donanemab for people in the early stages of Alzheimer's disease. Alzheimer's disease can affect memory, thinking, and daily activities. Finding effective treatments is very important.

The main purpose of this study is to check a few key things. First, how safe is Donanemab? Second, how well do people tolerate it – meaning, what side effects might there be and how do people feel while taking the medication? And finally, does Donanemab help with the symptoms of early Alzheimer's disease, or slow down its progression? To measure this, researchers will look at changes using a specific tool called the Integrated Alzheimer's Disease Rating Scale (iADRS).

This is a 'Phase II' study, which means it’s an important step in the development of new medicines. In this phase, a treatment that has shown some promise in very early testing is given to a larger group of people to see if it's safe and effective enough to move on to even bigger studies. The results from studies like this help scientists understand if a new treatment could eventually become widely available.

Key takeaways

This study is testing a new medicine, Donanemab, for early Alzheimer's.
It's a safety and effectiveness study (Phase II).
It aims to improve understanding and potentially manage Alzheimer's symptoms.
Participants will receive Donanemab or a placebo.
Open to adults (18+) with early Alzheimer's symptoms, male or female.

Who may be eligible?

To join this study, people generally need to be 18 years old or older. The study is open to both men and women. The most important factor is that participants must have been diagnosed with early symptomatic Alzheimer's disease.

This means that people who do not have symptoms of Alzheimer's, or those whose Alzheimer's is in a very advanced stage, might not be suitable for this particular study. The focus is specifically on early-stage symptoms.

Further specific criteria about your overall health, other medications you might be taking, and brain scans would also be important to determine if this study is the right fit for you. These detailed checks are done to ensure the study is safe and that results are clear.

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 18 years old or older?
Have you been diagnosed with early Alzheimer's disease?
Are you willing to attend regular clinic visits?
Are you comfortable with potentially receiving a placebo?
Have you discussed this type of study with your primary doctor?

Answer every question to see your result.

What does participation involve?

If you join this study, you would likely have regular visits to a clinic for examinations and assessments. These visits might include physical check-ups, blood tests, and memory or thinking tests to see how you are doing. You would also receive either the study medicine, Donanemab, other inactive substances like FLORBETAPIR or FLORTAUCIPIR, or a placebo (a dummy medicine that looks like the real thing but has no active ingredients). Receiving a placebo helps researchers compare the effects of Donanemab accurately. The total duration of your participation and the exact schedule of visits would be explained in detail by the study team. There would also be follow-up appointments after you stop taking the study medication to monitor your health.

Potential risks and benefits

Taking part in a clinical trial could offer potential benefits, such as access to a new Alzheimer's medication (Donanemab) before it's widely available, and close medical monitoring. However, there are also potential risks; you might experience side effects from the medication, which could range from mild to more serious. There's also no guarantee that the treatment will help your symptoms. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (3)

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

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Unverified
Netherlands
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Unverified
Czechia
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Unverified
Poland

Common questions

What is Donanemab?

Donanemab is the new, experimental medicine being tested in this study for early Alzheimer's disease.

What is 'Phase II'?

Phase II means it's an early stage of testing where researchers check safety and if the medicine generally helps people, before larger studies.

What is a placebo?

A placebo is a 'dummy' treatment that looks like the study medicine but doesn't contain any active drug. It helps researchers compare results fairly.

Who can join this study?

Adults (18+) with early symptomatic Alzheimer's disease, both men and women, might be eligible. Other health factors will also be checked.

Will I know if I get the active medicine?

Often, in these types of studies, neither you nor your doctor will know if you are receiving the active medicine or a placebo until after the study is complete, to keep the results fair.