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

Description

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.

Conditions

Alzheimer's Disease

Study Overview

Study Details

Study overview

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.

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

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

Condition
Alzheimer's Disease
Intervention / Treatment

-

Contacts and Locations

Birmingham

Parkway Medical Center, Birmingham, Alabama, United States, 35215

Chandler

MD First Research - Chandler, Chandler, Arizona, United States, 85286

Mesa

Care Access - 801 South Power Road, Mesa, Mesa, Arizona, United States, 85206

Phoenix

Banner Alzheimer's Institute, Phoenix, Arizona, United States, 85006

Tucson

Banner Alzheimer's Institute Tucson, Tucson, Arizona, United States, 85718

Fresno

Neuro-Pain Medical Center, Fresno, California, United States, 93710

Huntington Beach

Care Access - Huntington Beach, Huntington Beach, California, United States, 92648

Inglewood

Inglewood Clinical, Inglewood, California, United States, 90301

Irvine

Irvine Clinical Research, Irvine, California, United States, 92614

Long Beach

Healthy Brain Clinic, Long Beach, California, United States, 90804

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.
  • * 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.

Ages Eligible for Study

55 Years to 80 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Eli Lilly and Company,

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), STUDY_DIRECTOR, Eli Lilly and Company

Study Record Dates

2030-10