Assessment of Safety, Tolerability, and Efficacy Measured by Amyloid Reduction of LY3372993 in Early Symptomatic Alzheimer's Disease

  • End date
    Mar 27, 2025
  • participants needed
  • sponsor
    Eli Lilly and Company
Updated on 15 December 2022
mini-mental state examination


The reason for this study is to collect safety and efficacy information regarding the study drug remternetug in participants with early Alzheimer's disease (AD).


TRAILRUNNER-ALZ 1 is a Phase 3, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of remternetug in participants with early symptomatic AD. Participants will receive remternetug or placebo administered via subcutaneous injection or intravenous infusion.
Following the 52-week main study period, participants will continue participation for up to an additional 52 weeks in an extension period. Participants who previously received remternetug will receive placebo and participants who previously received placebo will receive remternetug. Thus, all participants will receive remternetug if they complete the study.
An additional 400 participants with early Alzheimer's disease will be enrolled to an addendum safety cohort. The participants will be administered open label remternetug via intravenous infusion. Participants from the addendum safety cohort are not eligible for the extension period.

Condition Alzheimer's Disease
Treatment Placebo, Remternetug (IV), Remternetug (SC)
Clinical Study IdentifierNCT05463731
SponsorEli Lilly and Company
Last Modified on15 December 2022


Yes No Not Sure

Inclusion Criteria

Gradual and progressive change in cognitive function ≥6 months prior to screening
A Mini-Mental (MMSE) score of 20 to 28 (inclusive) at screening
Has a P-tau result consistent with the presence of amyloid pathology
Has an amyloid PET scan result consistent with the presence of brain amyloid pathology
Have a reliable study partner who will provide written informed consent to participate and is in frequent contact with the participant
Have adequate literacy, vision, and hearing for the neuropsychological testing in the opinion of the investigator at the time of screening
Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures
Males and females will be eligible for this study
Women not of childbearing potential (WNOCBP) may participate in this trial

Exclusion Criteria

Significant neurological disease affecting the central nervous system (CNS) other than AD, that may affect cognition or ability to complete the study
Current serious or unstable illnesses that, in the investigator's opinion, could interfere with the analyses in this study; or has a life expectancy of <24 months
History of cancer with high risk of recurrence and preventing completion of the trial
Participants with any current primary psychiatric diagnosis other than AD that in the investigator's opinion, is likely to confound interpretation of the drug effect, affect cognitive assessment, or affect the participant's ability to complete the study
History of of clinically significant multiple or severe drug allergies
Have any clinically important abnormality at screening, as determined by investigator that could be detrimental to the participant, could compromise the study, or show evidence of other etiologies for dementia
Screening magnetic resonance imaging (MRI) which shows evidence of significant abnormality that would suggest another potential etiology for progressive dementia or a clinically significant finding that may impact the participant's ability to safely participate in the study
Have any contraindications for MRI or positron emission tomography (PET)
Have had prior treatment with a passive anti-amyloid immunotherapy that is <5 half-lives prior to randomization
Have received active immunization against Aβ in any other study
Have known allergies to remternetug related compounds, or any components of the formulation
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact


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


Browse trials for

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

user name

Added by • 



Reply by • Private

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note