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

NCT06653153
clinicaltrials.gov
Phase
Phase 3
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Recruitment status
Active, not recruiting
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Participants
1,400
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Lead sponsor
Eli Lilly and Company
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Start date
2024-10-24
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Number of sites
262
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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.
clinicaltrials.gov
Short title
A Study of Remternetug (LY3372993) in Early Alzheimer's Disease (TRAILRUNNER-ALZ 3)
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Official title
A Study of Remternetug Versus Placebo in Early Alzheimer's Disease Participants at Risk for Cognitive and Functional Decline
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Control arm
Placebo
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Active, not recruiting
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Phase
Phase 3
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Study type
Interventional
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Completion date
2030-10-01
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First posted
2024-10-22
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Registry last updated
2025-11-20
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Primary completion date
2029-04-01
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Start date
2024-10-24
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Participants
1,400
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Participant count basis
Estimated
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Planned participants
1,400
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Protocol amendments
2
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Number of sites
262
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
Eli Lilly and Company
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Source registry
ClinicalTrials.gov
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Registry ID
NCT06653153
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ClinicalTrials.gov ID
NCT06653153
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Double masking
Masked roles
Participants, Investigators
Sources for study design
clinicaltrials.gov

  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).

  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
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
55 Years
Maximum age
80 Years
Healthy volunteers
No

  • 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.

  • 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
clinicaltrials.gov

  • 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
clinicaltrials.gov

  • 2024-515656-20-00
  • J1G-MC-LAKI
Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (1)