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

Alzheimer's Disease

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.

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Participation Requirements

  • Sex:

    ALL
  • Eligible Ages:

    55 to 80

Participation Criteria

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 Location

The Medical Arts Health Research Group - West Vancouver
The Medical Arts Health Research Group - West Vancouver
West Vancouver, British Columbia
Canada

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Toronto Memory Program
Toronto Memory Program
Toronto, Ontario
Canada

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MoCA Research and Innovation Inc.
MoCA Research and Innovation Inc.
Greenfield Park, Quebec
Canada

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Q&T Research Sherbrooke Inc.
Q&T Research Sherbrooke Inc.
Sherbrooke, Quebec
Canada

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OCT Research ULC
OCT Research ULC
Kelowna, British Columbia
Canada

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Bluewater Clinical Research Group Inc.
Bluewater Clinical Research Group Inc.
Sarnia, Ontario
Canada

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Ecogene-21 - Cmas
Ecogene-21 - Cmas
Chicoutimi, Quebec
Canada

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Clinique Mémoire de Montréal
Clinique Mémoire de Montréal
Montréal, Quebec
Canada

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Ottawa Memory Clinic
Ottawa Memory Clinic
Ottawa, Ontario
Canada

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Sunnybrook Research Institute
Sunnybrook Research Institute
Toronto, Ontario
Canada

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Alpha Recherche Clinique - Lévis
Alpha Recherche Clinique - Lévis
Lévis, Quebec
Canada

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Diex Recherche Victoriavile Inc.
Diex Recherche Victoriavile Inc.
Victoriaville, Quebec
Canada

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Kawartha Centre - Redefining Healthy Aging
Kawartha Centre - Redefining Healthy Aging
Peterborough, Ontario
Canada

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Baycrest Health Sciences
Baycrest Health Sciences
Toronto, Ontario
Canada

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Genge Partners
Genge Partners
Montreal, Quebec
Canada

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Study Sponsored By
Eli Lilly and Company
Participants Required
More Information
Study ID: NCT06653153