A Study of Remternetug (LY3372993) in Participants With Alzheimer's Disease (TRAILRUNNER-ALZ 1)

Completed · Phase 3 · Has a placebo group

Conditions studied: Alzheimer's Disease

In brief

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).

Key facts

Study ID

NCT05463731

Run by

Eli Lilly and Company

People needed

1667

Starts

2022-08-01

Expected to finish

2026-05-12

Last updated by the study team

2026-05-22

Who can join

Age: 60 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 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.
• Have received active immunization against Aβ in any other study.
• Have known allergies to remternetug related compounds, or any components of the formulation.

Where it is running

• Hope Clinical Research, Inc. — Canoga Park, California, United States
• North County Neurology Associates — Carlsbad, California, United States
• Wr- Pri, Llc — Encino, California, United States
• Neuro-Pain Medical Center — Fresno, California, United States
• Irvine Clinical Research — Irvine, California, United States
• Kaizen Brain Center — La Jolla, California, United States
• Anderson Clinical Research — Redlands, California, United States
• Mountain Neurological Research Center — Basalt, Colorado, United States
• Alpine Clinical Research Center — Boulder, Colorado, United States
• Colorado Springs Neurological Associates — Colorado Springs, Colorado, United States
• Institute for Neurodegenerative Disorders — New Haven, Connecticut, United States
• Ki Health Partners, LLc, dba New England Institute for Clinical Research — Stamford, Connecticut, United States
• JEM Research Institute — Atlantis, Florida, United States
• VIN-Julie Schwartzbard — Aventura, Florida, United States
• Brain Matters Research — Delray Beach, Florida, United States
• Neuropsychiatric Research Center of Southwest Florida — Fort Myers, Florida, United States
• Finlay Medical Research — Greenacres City, Florida, United States
• Encore Research Group- Jacksonville Center for Clinical Research — Jacksonville, Florida, United States
• ClinCloud - Maitland — Maitland, Florida, United States
• K2 Medical Research — Maitland, Florida, United States
• ClinCloud - Viera — Melbourne, Florida, United States
• Merritt Island Medical Research, LLC — Merritt Island, Florida, United States
• VIN-Andrew Lerman — Miami, Florida, United States
• Optimus U Corporation — Miami, Florida, United States
• MD First Research - Chandler — Chandler, Arizona, United States

Full record on ClinicalTrials.gov

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