A Study of Remternetug (LY3372993) in Participants With Alzheimer's Disease (TRAILRUNNER-ALZ 1) (NCT05463731) | Clinical Trial Compass
Active — Not RecruitingPhase 3
A Study of Remternetug (LY3372993) in Participants With Alzheimer's Disease (TRAILRUNNER-ALZ 1)
United States1,667 participantsStarted 2022-08-01
Plain-language summary
The reason for this study is to collect safety and efficacy information regarding the study drug remternetug in participants with early symptomatic Alzheimer's disease (AD).
Who can participate
Age range60 Years – 85 Years
SexALL
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Inclusion Criteria:
* Gradual and progressive change in cognitive function ≥6 months prior to screening.
* A Mini-Mental (MMSE) score of 20 to 30 (inclusive) at screening.
* Has an amyloid PET scan result consistent with the eligibility criteria.
* 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:
* 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 clinically significant multiple or severe drug allergies.
* Have any clinically important abnormality at screening, as determined by investigator that could be det…
What they're measuring
1
Percentage of Participants Who Reach Amyloid Plaque Clearance on Amyloid PET Scan for Remternetug versus Placebo