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

Lilly

Status and phase: Enrolling; Phase 3

Conditions: Alzheimer's Disease

Treatments: Drug: Placebo; Drug: Remternetug

Study type: Interventional

Funder types: Industry

Identifiers

NCT06653153

J1G-MC-LAKI (Other Identifier)

27183

2024-515656-20 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 1,200 estimated patients

Sex: All

Ages: 55 to 80 years old

Volunteers: No Healthy Volunteers

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 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 demonstrating presence of ARIA-E, >4 cerebral microhemorrhages, any superficial siderosis, any macrohemorrhage, or severe white matter disease at screening.

Prior or Current Therapies

• Have had prior treatment with a passive anti-amyloid immunotherapy within <5 half-lives prior to screening.
• Have received active immunization against Aβ in any other study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

1,200 participants in 2 patient groups, including a placebo group

Remternetug

Experimental group

Description:

Remternetug administered subcutaneously (SC).

Treatment:

Drug: Remternetug

Placebo

Placebo Comparator group

Description:

Placebo administered SC.

Treatment:

Drug: Placebo