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

Phase 3

Recruiting

• Conditions: Alzheimer's Disease
• Interventions: Drug: Remternetug; Drug: Placebo

• Registration Number: NCT06653153
• Lead Sponsor: Eli Lilly and Company

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-10-21
• Study First Submitted QC: 2024-10-21
• Study First Posted: 2024-10-22
• Study Start: 2024-10-24
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-07
• Last Update Posted: 2025-07-08
• Primary Completion: 2029-04
• Study Completion: 2030-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Remternetug	Remternetug	Remternetug administered subcutaneously (SC).
Placebo	Placebo	Placebo administered SC.

Primary Outcome Measures

Name	Time	Method
Time to Clinically Meaningful Progression as Measured by Clinical Dementia Rate (CDR)	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 Outcome Measures

Name	Time	Method
Change from Baseline in Clinical Dementia Rate Box Score (SB)	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.
Change from Baseline in Montreal Cognitive Assessment (MoCA)	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.
Change from Baseline in the Category Fluency - Language, Executive Function, Semantic Memory	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.
Change from Baseline in the Continuous Paired Associate Learning (CPAL)	Baseline, Week 255	Change from baseline in Continuous Paired Associate Learning (CPAL) - Visual episodic memory.
Change from Baseline in International Shopping List Test (ISLT) - Verbal Episodic Mem	Baseline, Week 255	Change from baseline in the International Shopping List Test (ISLT) - verbal episodic memory.
Change from Baseline in International Daily Symbol Substitution Test-Medicines (iDSSTm) - Complex Attention Memory	Baseline, Week 255	Change from baseline in the International Daily Symbol Substitution Test-Medicines (iDSSTm) - complex attention memory.
Change from Baseline in Cogstate Brief Battery (CBB) - Psychomotor Function, Attention, Learning and Working Memory	Baseline, Week 255	Change from baseline in the Cogstate Brief Battery (CBB) - Psychomotor function, attention, learning, and working memory.
Change from Baseline in Cognitive Function Index (CFI)	Baseline, Week 255	Change from baseline in the Cognitive Function Index (CFI).
Change from Baseline in Mild Behavioral Impairment Checklist (MBI-C)	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.
Change from Baseline in Alzheimer's Disease Cooperative Study (ADCS) Activities of Daily Living - Prevention Instrument (ADCS-ADL-PI)	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.
Pharmacokinetics: Serum Concentrations of Remternetug	Baseline through Week 255	PK: serum concentration of remternetug.
Number of Participants with Treatment Emergent Anti-Drug Antibodies (TE-ADAs)	Baseline through Week 255	Number of participants with treatment emergent anti-drug antibodies (TE-ADAs).

Trial Locations

Locations (313)

Parkway Medical Center; 🇺🇸 Birmingham, Alabama, United States

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

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