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

  • STATUS
    Recruiting
  • End date
    Mar 27, 2025
  • participants needed
    400
  • sponsor
    Eli Lilly and Company
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Updated on 15 December 2022
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mini-mental state examination
amyloid

Summary

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).

Description

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.

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

Eligibility

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

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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.

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

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