Remternetug for Alzheimer's Disease

Recruiting at 339 trial locations

Overseen By Dung Trinh

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Eli Lilly and Company

Must not be taking: Anti-amyloid immunotherapy

Disqualifiers: Dementia, Neurological disease, Cancer, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

1200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a new treatment, remternetug, can slow or prevent issues with memory, thinking, and daily tasks in people with early Alzheimer's disease. Participants will receive either remternetug or a placebo (a substance with no active drug) to compare outcomes. The trial seeks individuals who are beginning to show memory or thinking problems and have a study partner familiar with their daily activities. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking treatment.

Will I have to stop taking my current medications?

The trial protocol does not specify if you must stop taking your current medications. However, if you are taking medications for Alzheimer's disease, your dose should have been stable for at least 30 days before joining the trial.

Is there any evidence suggesting that remternetug is likely to be safe for humans?

Research has shown that remternetug, the treatment under study for Alzheimer's disease, has undergone testing in earlier studies to assess its safety for individuals with early symptoms of Alzheimer's. Although specific safety details from those studies are not available, the trial's advanced phase suggests that earlier studies likely found remternetug to be generally safe for participants, without major safety issues.

Before reaching this stage, earlier trials would have identified any manageable side effects. Therefore, even without detailed safety data here, remternetug has likely passed initial safety tests in human studies. Participants in this trial can expect that the treatment has been deemed safe enough to proceed to this more advanced testing stage. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Alzheimer's?

Remternetug is unique because it targets Alzheimer's disease by using a novel mechanism of action. Unlike standard treatments like donepezil or memantine, which primarily focus on managing symptoms, Remternetug is an antibody that targets amyloid plaques in the brain. This approach aims to address one of the underlying causes of Alzheimer's rather than just alleviating its symptoms. Researchers are excited because this could potentially slow the progression of the disease, offering hope for more effective long-term management. Additionally, Remternetug is administered subcutaneously, which might offer a more convenient delivery method compared to other options.

What evidence suggests that remternetug might be an effective treatment for Alzheimer's?

Research has shown that remternetug, which participants in this trial may receive, might help treat Alzheimer's disease, especially in its early stages. Studies have found that this treatment reduces amyloid plaques, proteins believed to play a role in Alzheimer's. In a similar study, another treatment called donanemab slowed the disease's progression by 32% over 18 months compared to a placebo. These findings suggest that remternetug could potentially slow the decline in memory and thinking skills linked to Alzheimer's. However, more research is needed to confirm these results. ^{1 2 3 4 6}

Who Is on the Research Team?

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)

Principal Investigator

Eli Lilly and Company

Are You a Good Fit for This Trial?

This trial is for individuals with early Alzheimer's disease who experience agitation and dementia. Participants should be willing to commit up to almost 5 years, including treatment and observation periods. Details on specific inclusion or exclusion criteria are not provided.

Inclusion Criteria

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

Exclusion Criteria

Have a history of clinically significant multiple or severe drug allergies, or hypersensitivity reactions

Have received active immunization against Aβ in any other study

I do not have any serious illnesses that could affect study results.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Double-blind Treatment

Participants receive either remternetug or placebo subcutaneously

Up to 255 weeks

Double-blind Observation

Participants are monitored for cognitive and functional decline

Up to 255 weeks

Open-label Extension (optional)

Eligible participants who received placebo may opt to receive open-label remternetug

Long-term

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Remternetug

Trial Overview The study tests Remternetug against a placebo to see if it can delay the progression of memory, thinking, or functional issues in Alzheimer's patients. It includes a double-blind phase where neither participants nor researchers know who gets the real drug or placebo.

How Is the Trial Designed?

Group I: Remternetug Experimental Treatment 1 Intervention

Remternetug administered subcutaneously (SC).

Group II: Placebo Placebo Group 1 Intervention

Placebo administered SC.

Who Is Running the Clinical Trial?

Eli Lilly and Company

Lead Sponsor

Trials

2,708

Recruited

3,720,000+

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University

Published Research Related to This Trial

Acetylcholinesterase inhibitors are the first-line treatment for Alzheimer disease, providing mild improvements in cognitive function and daily living activities, but their clinical significance is uncertain due to common side effects like nausea and dizziness.

Memantine, an N-methyl-D-aspartate receptor antagonist, can modestly improve cognition and behavior in moderate to severe Alzheimer disease and is generally well tolerated, but its overall clinical benefits remain debated.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of Alzheimer disease. Winslow, BT., Onysko, MK., Stob, CM., et al.[2014]

Aducanumab is the first novel therapy approved for Alzheimer's disease that targets the β-amyloid cascade, representing a potential disease-modifying treatment rather than just symptomatic relief.

Combining existing therapies, such as cholinesterase inhibitors and memantine, has shown functional effectiveness in treating moderately severe Alzheimer's disease, suggesting that a multi-faceted approach may be beneficial for addressing the complex nature of the disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacotherapeutic combinations for the treatment of Alzheimer's disease. Nagata, T., Shinagawa, S., Nakajima, S., et al.[2022]

Donanemab, administered at a dose of 10 mg/kg, was generally well tolerated in patients with mild cognitive impairment or mild to moderate Alzheimer's disease, showing a significant reduction of amyloid deposits by 40% to 50%.

Despite a shorter than expected half-life of approximately 10 days at the highest dose, about 90% of subjects developed anti-drug antibodies within 3 months, indicating a robust immune response to the treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Donanemab (LY3002813) dose-escalation study in Alzheimer's disease. Lowe, SL., Willis, BA., Hawdon, A., et al.[2022]

In a 6-month observational study involving patients with moderate to severe Alzheimer's disease, memantine treatment at 20 mg/day led to significant improvements in cognitive function and daily activities, with 78.8% of patients showing improvement or stabilization.

Memantine was well-tolerated by patients, reinforcing its safety profile and efficacy as previously established in controlled clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Memantine (Ebixa) in clinical practice - results of an observational study. Calabrese, P., Essner, U., Forstl, H.[2013]

In a study involving 30 patients aged 55 to 84 with moderate to severe Alzheimer's disease, memantal (a generic form of memantine) demonstrated moderate positive effects on cognitive functions and daily activities over a 3-month treatment period.

The treatment was found to be safe, with no adverse effects reported, indicating that memantal is both effective and well-tolerated for managing symptoms of Alzheimer's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Clinical experience of the use of memantal in patients with moderate and severe Alzheimer's disease]. Gavrilova, SI., Kolykhalov, IV., Kulik, AS., et al.[2018]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05463731

NCT05463731 | A Study of Remternetug (LY3372993) in ... The reason for this study is to collect safety and efficacy information regarding the study drug remternetug in participants with early symptomatic Alzheimer's ...

2. neurologylive.com neurologylive.com/view/phase-3-trailrunner-alz-3-test-effects-igg1-monoclonal-antibody-remternetug-early-alzheimer-disease

Phase 3 TRAILRUNNER-ALZ 3 to Test Effects of IgG1 ... The phase 3 study will assess remternetug's efficacy in early-stage Alzheimer's, focusing on amyloid plaque reduction and cognitive outcomes.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06653153

A Study of Remternetug (LY3372993) in Early Alzheimer's ... 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.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10544555/

Clinical trials of new drugs for Alzheimer disease In the TRAILBLAZER-ALZ study, donanemab slowed disease progression by 32% at 18 months (p = 0.04 vs. placebo), thus demonstrating clinical efficacy [51].

5. trials.lilly.com trials.lilly.com/en-US/trial/548297

A Study of Remternetug (LY3372993) in Early Alzheimer's ... 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.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10531090/

Treatment of Alzheimer's Disease: Beyond Symptomatic ... Data on phase III clinical trials showed that failure of clinical trials is mainly due to the following limitations: (1) dementia was too severe ...