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NCT Number: NCT06653153

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Alzheimer's Disease Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

55 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

USC Clinical Trials Sunshine Coast, Birtinya, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Remternetug

Drug

Administered SC

Other names: LY3372993

Placebo

Drug

Administered SC

Primary outcomes

  1. Time to Clinically Meaningful Progression as Measured by Clinical Dementia Rate Scale (CDR)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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

    Time frame: 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)

    Time frame: 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

    Time frame: 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

    Time frame: 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)

    Time frame: Baseline, Week 255

    Change from baseline in the Cognitive Function Index (CFI).

  8. Change from Baseline in Mild Behavioral Impairment Checklist (MBI-C)

    Time frame: 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)

    Time frame: 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

    Time frame: Baseline through Week 255

    PK: serum concentration of remternetug.

  11. Number of Participants with Treatment Emergent Anti-Drug Antibodies (TE-ADAs)

    Time frame: Baseline through Week 255

    Number of participants with treatment emergent anti-drug antibodies (TE-ADAs).

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

A Study of Remternetug Versus Placebo in Early Alzheimer's Disease Participants at Risk for Cognitive and Functional Decline

Important dates

Study start
2024
Primary completion
2029
Study completion
2030
First posted
Oct 22, 2024
Registry last updated
Nov 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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