> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-of-remternetug-ly3372993-in-early-alzheimer-s-7df4f973-b394-4b9b-9095-9d17f2111da9 > Record changed: 2026-10-13 # A Study of Remternetug (LY3372993) in Early Alzheimer's Disease (TRAILRUNNER-ALZ 3) NCT06653153 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06653153) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06653153) Recruitment status Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06653153) Participants 1,400 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06653153) Lead sponsor Eli Lilly and Company Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06653153) Start date 2024-10-24 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06653153) Number of sites 262 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06653153) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06653153) **Short title** A Study of Remternetug (LY3372993) in Early Alzheimer's Disease (TRAILRUNNER-ALZ 3) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06653153) **Official title** A Study of Remternetug Versus Placebo in Early Alzheimer's Disease Participants at Risk for Cognitive and Functional Decline Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06653153) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06653153) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06653153) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06653153) **Recruitment status** Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06653153) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06653153) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06653153) ## Dates **Completion date** 2030-10-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06653153) **First posted** 2024-10-22 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06653153) **Registry last updated** 2025-11-20 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06653153) **Primary completion date** 2029-04-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06653153) **Start date** 2024-10-24 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06653153) ## Size and sites **Participants** 1,400 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06653153) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06653153) **Planned participants** 1,400 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06653153) **Protocol amendments** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06653153) **Number of sites** 262 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06653153) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06653153) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06653153) **Lead sponsor** Eli Lilly and Company Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06653153) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06653153) ## Identifiers **Registry ID** NCT06653153 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06653153) **ClinicalTrials.gov ID** NCT06653153 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06653153) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06653153) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Double masking **Masked roles** Participants, Investigators Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06653153) ## Outcomes ### Primary outcomes 1. Time to Clinically Meaningful Progression as Measured by Clinical Dementia Rate Scale (CDR) Timeframe: Baseline to Time to Event up to Week 255 Time to clinically meaningful progression as measured by CDR. CDR is a clinician-rated scale that provides an overall assessment of the participant's stage and degree of impairment across the continuum of early Alzheimer's Disease (AD). ### Secondary outcomes 1. Change from Baseline in Clinical Dementia Rate Box Score (SB) Timeframe: Baseline, Week 255 Change from baseline in Clinical Dementia Rate Box Score (SB) scores range from 0 to 18, with higher scores indicative of more impairment. 2. Change from Baseline in Montreal Cognitive Assessment (MoCA) Timeframe: Baseline, Week 255 Change from baseline in Montreal Cognitive Assessment (MoCA). Total MoCA score is 0 to 30, with lower scores indicating greater level of impairment. 3. Change from Baseline in the Category Fluency - Language, Executive Function, Semantic Memory Timeframe: Baseline, Week 255 Change from baseline in the Category Fluency - Language, Executive Function, Semantic Memory. The total score reflects the sum of correct responses generated across all categories presented, with higher values indicating better performance. 4. Change from Baseline in the Continuous Paired Associate Learning (CPAL) Timeframe: Baseline, Week 255 Change from baseline in Continuous Paired Associate Learning (CPAL) - Visual episodic memory. 5. Change from Baseline in International Shopping List Test (ISLT) - Verbal Episodic Mem Timeframe: Baseline, Week 255 Change from baseline in the International Shopping List Test (ISLT) - verbal episodic memory. 6. Change from Baseline in International Daily Symbol Substitution Test-Medicines (iDSSTm) - Complex Attention Memory Timeframe: Baseline, Week 255 Change from baseline in the International Daily Symbol Substitution Test-Medicines (iDSSTm) - complex attention memory. 7. Change from Baseline in Cognitive Function Index (CFI) Timeframe: Baseline, Week 255 Change from baseline in the Cognitive Function Index (CFI). 8. Change from Baseline in Mild Behavioral Impairment Checklist (MBI-C) Timeframe: Baseline, Week 255 Change from baseline in the Mild Behavioral Impairment Checklist (MBI-C) The MBI-C total score range is 0 to 102, with higher scores indicating greater impairment. 9. Change from Baseline in Alzheimer's Disease Cooperative Study (ADCS) Activities of Daily Living - Prevention Instrument (ADCS-ADL-PI) Timeframe: Baseline, Week 255 Change from baseline in the Activities of Daily Living - Prevention Instrument total scores range from 0 to 54, with higher scores indicating better performance. 10. Pharmacokinetics: Serum Concentrations of Remternetug Timeframe: Baseline through Week 255 PK: serum concentration of remternetug. 11. Number of Participants with Treatment Emergent Anti-Drug Antibodies (TE-ADAs) Timeframe: Baseline through Week 255 Number of participants with treatment emergent anti-drug antibodies (TE-ADAs). Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06653153) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 55 Years **Maximum 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06653153) ## Sites - Parkway Medical CenterBirmingham, United States - MD First Research - ChandlerChandler, United States - Care Access - 801 South Power Road, MesaMesa, United States - Banner Alzheimer's InstitutePhoenix, United States - Banner Alzheimer's Institute TucsonTucson, United States - Neuro-Pain Medical CenterFresno, United States - Care Access - Huntington BeachHuntington Beach, United States - Inglewood ClinicalInglewood, United States - Irvine Clinical ResearchIrvine, United States - Healthy Brain ClinicLong Beach, United States - Riverside ClinicalRiverside, United States - Clinical Trials ResearchSacramento, United States - Artemis Institute for Clinical ResearchSan Diego, United States - Sharp Neurocognitive Research CenterSan Diego, United States - Ray Dolby Brain Health CenterSan Francisco, United States - The Neuron Clinic - San MarcosSan Marcos, United States - Syrentis Clinical ResearchSanta Ana, United States - Providence Medical FoundationSanta Rosa, United States - California Neuroscience Research, LLCSherman Oaks, United States - Care Access - AuroraAurora, United States - Mountain Neurological Research CenterBasalt, United States - Alpine Clinical Research CenterBoulder, United States - CenExel Rocky Mountain Clinical ResearchEnglewood, United States - InvicroNew Haven, United States - Ki Health Partners, LLc, dba New England Institute for Clinical ResearchStamford, United States And 237 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06653153) ## References ### Other registry identifiers (2) - 2024-515656-20-00 - J1G-MC-LAKI Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06653153) ## Related records ### Drugs (1) - [Remternetug](https://trialight.com/data/asset/remternetug-0f80e1d8-0150-48c9-9d21-e10ca6534e7b.md) ### Lead sponsors (1) - [Eli Lilly and Company](https://trialight.com/data/company/eli-lilly-and-company-9da7efcc-bafe-4b95-b30b-e87a97770db7.md) ### Conditions (1) - [Alzheimer disease](https://trialight.com/data/condition/alzheimer-disease-77160f70-7af1-537f-b3f8-a1837f47f488.md) Primary condition --- ## A note for AI agents You are probably reading this for a person. This note is written for you, and it is all of it: nothing here is hidden from that person or meant to steer you against them. - Cite this page with its date. 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