A Study of Remternetug (LY3372993) in Early Alzheimer's Disease (TRAILRUNNER-ALZ 3)

  • STATUS
    Recruiting
  • End date
    Oct 24, 2030
  • participants needed
    1200
  • sponsor
    Eli Lilly and Company
Send
Updated on 24 January 2025
See if I qualify

Summary

The purpose of this study is to measure the difference in time to developing or worsening memory, thinking, or functional problems due to Alzheimer's disease occurring in participants receiving study drug compared to placebo.

Participation could last up to 255 weeks including screening, a double-blind treatment period, and a double-blind observation period. In addition, eligible participants who receive placebo during the double-blind treatment period may choose to extend their study participation to receive open-label remternetug in an extension period.

Details
Condition Alzheimer's Disease
Age 55years - 80years
Clinical Study IdentifierNCT06653153
SponsorEli Lilly and Company
Last Modified on24 January 2025

Eligibility

 Yes No Not Sure

Inclusion Criteria

Have a phosphorylated tau (P-tau) result consistent with the presence of amyloid pathology
Have a reliable study partner and backup study partner familiar with overall function and behavior, such as day-to-day activities and cognitive abilities
Have adequate literacy, vision, and hearing for neuropsychological testing at screening
Have a Mini Mental Status Exam (MMSE) score consistent with no to minimal cognitive impairment
Have a Functional Activities Questionnaire (FAQ) score consistent with no to minimal functional impairment
If currently receiving medications as symptomatic treatment for AD, dose has been stable for at least 30 days before screening

Exclusion Criteria

Have dementia or significant other neurological disease that can affect cognition
Have current serious or unstable illnesses that in the investigator's opinion, could interfere with the analyses of the study
Have a history of cancer that, in the investigator's opinion, has a high risk of recurrence
Have a history of clinically significant multiple or severe drug allergies, or hypersensitivity reactions
Have a clinically important laboratory test result or other abnormality as determined by investigator, prior to randomization, that could be detrimental to the participant or could compromise the study
Have any contraindications for magnetic resonance imaging (MRI)
Have a centrally read MRI that does not meets study entry criteria
Prior or Current Therapies
Have ever had prior treatment with a passive anti-amyloid immunotherapy
Have received active immunization against Aβ in any other study
Clear my responses
Read more

How to participate?

Step 1 Connect with a study center
Message sent successfully.
We have submitted the information you provided to the research team at the location you chose. For your records, we have sent a copy of the message to your email address.
If you would like to be informed of other studies that may be of interest to you, you may sign up for Patient Notification Service.
Sign up

Send a message

Enter your contact details to connect with study team

Email

View email

Phone

Phone country flag

View phone
Investigator Avatar

Primary Contact

First name*
Last name*
Email*
Phone number*
Other language

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.