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Remternetug for Alzheimer's Disease

Phase 3

Recruiting

Research Sponsored by Eli Lilly and Company

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have you been noticing a gradual decline in your memory or other thinking-related functions for more than 6 months?

Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to week 52

Awards & highlights

Pivotal Trial

Summary

This trial tests remternetug, a drug given by injection or IV, in people with early Alzheimer's disease. It aims to find out if the drug is safe and can help improve symptoms or slow down the disease.

Who is the study for?

This trial is for individuals with early Alzheimer's who've noticed memory or cognitive decline over 6+ months. They need a reliable partner to assist with the study, must not have other neurological diseases affecting cognition, and should be able to undergo neuropsychological testing.

What is being tested?

The study tests Remternetug's safety and effectiveness in treating early Alzheimer's disease. Participants will receive either a placebo or Remternetug through subcutaneous (SC) injections or intravenous (IV) infusions.

What are the potential side effects?

While specific side effects of Remternetug are not listed here, common side effects in trials may include injection site reactions, fatigue, nausea, and potential allergic responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have experienced a decline in memory or thinking for over 6 months.

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I am committed to following the study's schedule and procedures.

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Do you have a friend or family member who can help you with study visits and answer questions about your health?

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I do not have a neurological condition affecting my memory, excluding Alzheimer's or dementia.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to week 52

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to week 52

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to week 52 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Mean Absolute Change from Baseline in Brain Amyloid Plaque on Amyloid PET Scan for Remternetug versus Placebo

Number of Participants with Treatment Emergent Anti-Drug Antibodies (TE-ADAs)

Percentage of Participants Who Reach Amyloid Plaque Clearance on Amyloid PET Scan for Remternetug versus Placebo

+2 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

5Treatment groups

Experimental Treatment

Placebo Group

Group I: Remternetug (SC)Experimental Treatment1 Intervention

Participants will receive one of two dosing regimens of remternetug subcutaneously (SC) Participants will receive remternetug SC during the treatment period, then switch to placebo SC in the extension period.

Group II: Remternetug (IV)Experimental Treatment1 Intervention

Participants will receive remternetug intravenously (IV) Participants will receive remternetug IV during the treatment period, then switch to placebo IV in the extension period.

Group III: Open-Label Addenda Remternetug (SC)Experimental Treatment1 Intervention

Participants will receive one of two dosing regimens of remternetug SC during the open-label addenda.

Group IV: Open-Label Addenda Remternetug (IV)Experimental Treatment1 Intervention

Participants will receive one of three dosing regimens of remternetug IV during the open-label addenda.

Group V: PlaceboPlacebo Group1 Intervention

Participants will receive placebo matching remternetug IV or SC. Participants will receive placebo IV during the treatment period, then switch to remternetug IV in the extension period. Participants will receive placebo SC during the treatment period, then switch to LY3372993 SC in the extension period.

0 / 4Eligibility criteria met