TRAILRUNNER-ALZ 3

Information about the drug that will be tested in the study

Administration

The drug will be administered via a subcutaneous injection (an injection under the skin).

Is the drug already on the market for another medical condition?

No

Will all participants receive the same drug?

Participants will be selected by chance to receive one of the following options:

• A subcutaneous injection of remternetug
• A subcutaneous injection of placebo (also called a dummy treatment which is an inactive substance identical in appearance to the drug being tested with no active therapeutic effect).

Neither the participant nor his/her doctor will know if the person is receiving the investigational drug or the placebo.

Information about participating in the trial

What are the researchers trying to find out?

The study will evaluate the safety and efficacy of remternetug in participants who have early Alzheimer’s disease. The primary objective will assess whether treatment with remternetug delays the time to clinically meaningful progression as compared to placebo.

How long will the treatment last?

This study will last about 5 years, including a screening, a treatment period of 78 weeks and an observation period.

In addition, eligible participants who receive placebo during the treatment period may choose to extend their study participation to receive remternetug in an extension period.

What your involvement will entail?

During the study, participants will be asked:

• To complete tests that will assess their memory, cognition, functional and daily activities (MMSE, FAQ, CDR-SB, MoCA, ADCS)
• To complete some laboratory tests and neurological examination to evaluate the emergent adverse events (unfavourable signs, symptoms or diseases temporally associated with the use of the drug tested in the study)
• Undergo brain scans (MRI).

Further information on the procedures, tests and number of visits can be obtained from the study team.

Who can participate in this study?

Who can participate in the study?

To take part in the study, participants must (main inclusion criteria):

• Be between 55 and 80 years old
• Have amyloid pathology in the brain (blood test)
• Have a study partner who is willing to participate in study procedures throughout the study duration
• Have adequate literacy, vision and hearing for neuropsychological testing
• Have a score ≥27 in the MMSE test and <6 in the Functional Activities Questionnaire. This would suggest that the person has no or only mild problems with memory and function
• If the person is taking a symptomatic treatment for Alzheimer’s disease, the dosing regimen must have been stable for at least 1-month weeks prior to the study inclusion.

Who cannot participate in the study?

People cannot take part in the study if they have (main exclusion criteria):

• Dementia or a significant other neurological disease that can affect cognition
• A current serious medical condition or abnormality that could increase the risk to their safety or could interfere with the results of this study
• Any history of severe drug allergies or hypersensitivity reactions
• A disease that may interfere with the safety or study assessments (e.g., pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, cardiovascular, or oncologic disease)
• Any contraindications for brain scans (MRI).

Information for your doctor

EU-CT Number

2024-515656-20-00

Clinicaltrials.gov identifier

NCT06653153

Study contact information

clinical_inquiry_hub@lilly.com

Link to full text

https://clinicaltrials.gov/study/NCT06653153

https://euclinicaltrials.eu/ctis-public/view/2024-515656-20-00

Link to website dedicated to study:

https://lillyadresearch.com/trailrunner-alz-3/

The information contained in this document is based on information available on public registries (e.g. clinicaltrials.gov, CTIS websites) in April 2025.

This document has been reviewed by a member of the European Dementia Carers Working Group.