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Clinical Trials in the USA / NCT06653153
Active, not recruiting Phase 3

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

NCT06653153 · tracked via the Priya Life Science USA tracker
Sponsor
Eli Lilly and Company
Phase
Phase 3
Started
2024-10-24
Last updated
2025-11-20

Condition(s) studied

Alzheimer's Disease

Investigational drug(s) / intervention(s)

RemternetugPlacebo

Remternetug: Administered SC

Placebo: Administered SC

Study summary

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.

Eligibility

Sex
ALL
Min age
55 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Primary outcome measure(s)

Trial sites (262)

FacilityCityRegionStatus
Parkway Medical Center Birmingham Alabama
MD First Research - Chandler Chandler Arizona
Care Access - 801 South Power Road, Mesa Mesa Arizona
Banner Alzheimer's Institute Phoenix Arizona
Banner Alzheimer's Institute Tucson Tucson Arizona
Neuro-Pain Medical Center Fresno California
Care Access - Huntington Beach Huntington Beach California
Inglewood Clinical Inglewood California
Irvine Clinical Research Irvine California
Healthy Brain Clinic Long Beach California
Riverside Clinical Riverside California
Clinical Trials Research Sacramento California
Artemis Institute for Clinical Research San Diego California
Sharp Neurocognitive Research Center San Diego California
Ray Dolby Brain Health Center San Francisco California
The Neuron Clinic - San Marcos San Marcos California
Syrentis Clinical Research Santa Ana California
Providence Medical Foundation Santa Rosa California
California Neuroscience Research, LLC Sherman Oaks California
Care Access - Aurora Aurora Colorado
Mountain Neurological Research Center Basalt Colorado
Alpine Clinical Research Center Boulder Colorado
CenExel Rocky Mountain Clinical Research Englewood Colorado
Invicro New Haven Connecticut
Ki Health Partners, LLc, dba New England Institute for Clinical Research Stamford Connecticut
JEM Research Institute Atlantis Florida
VIN - Aventura Aventura Florida
Bradenton Research Center, Inc. Bradenton Florida
K2 Medical Research WINTER GARDEN Clermont Florida
TecTum Research Davie Florida
Brain Matters Research Delray Beach Florida
Neuropsychiatric Research Center of Southwest Florida Fort Myers Florida
Indago Research & Health Center, Inc Hialeah Florida
K2 MEDICAL Research THE VILLAGES Lady Lake Florida
ClinCloud Maitland Florida
K2 Medical Research ORLANDO Maitland Florida
ClinCloud Melbourne Florida
Merritt Island Medical Research, LLC Merritt Island Florida
VIN-Andrew Lerman Miami Florida
New Age Medical Research Corporation Miami Florida

+ 222 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06653153 on ClinicalTrials.gov ↗ ← All trials in the USA