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

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Alzheimer's Disease

In brief

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.

Key facts

Study ID

NCT06653153

Run by

Eli Lilly and Company

People needed

1400

Starts

2024-10-24

Expected to finish

2030-10-01

Last updated by the study team

2025-11-20

Who can join

Age: 55 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• MD First Research - Chandler — Chandler, Arizona, United States
• Care Access - 801 South Power Road, Mesa — Mesa, Arizona, United States
• Banner Alzheimer's Institute — Phoenix, Arizona, United States
• Banner Alzheimer's Institute Tucson — Tucson, Arizona, United States
• Neuro-Pain Medical Center — Fresno, California, United States
• Care Access - Huntington Beach — Huntington Beach, California, United States
• Inglewood Clinical — Inglewood, California, United States
• Irvine Clinical Research — Irvine, California, United States
• Healthy Brain Clinic — Long Beach, California, United States
• Riverside Clinical — Riverside, California, United States
• Clinical Trials Research — Sacramento, California, United States
• Artemis Institute for Clinical Research — San Diego, California, United States
• Sharp Neurocognitive Research Center — San Diego, California, United States
• Ray Dolby Brain Health Center — San Francisco, California, United States
• The Neuron Clinic - San Marcos — San Marcos, California, United States
• Syrentis Clinical Research — Santa Ana, California, United States
• Providence Medical Foundation — Santa Rosa, California, United States
• California Neuroscience Research, LLC — Sherman Oaks, California, United States
• Care Access - Aurora — Aurora, Colorado, United States
• Mountain Neurological Research Center — Basalt, Colorado, United States
• Alpine Clinical Research Center — Boulder, Colorado, United States
• CenExel Rocky Mountain Clinical Research — Englewood, Colorado, United States
• Invicro — New Haven, Connecticut, United States
• Ki Health Partners, LLc, dba New England Institute for Clinical Research — Stamford, Connecticut, United States
• Parkway Medical Center — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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