Remternetug for Alzheimer's Disease

Recruiting in Palo Alto (17 mi)

+339 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: Eli Lilly and Company

Must not be taking: Anti-amyloid immunotherapy

Disqualifiers: Dementia, Neurological disease, Cancer, others

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

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.

How is the drug Remternetug different from other Alzheimer's treatments?

Remternetug is unique because it is a novel treatment targeting the beta-amyloid cascade in the brain, which is believed to play a key role in Alzheimer's disease, unlike traditional treatments that mainly focus on symptom management. ^{1 2 3 4 5}

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

Eligibility Criteria

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 a Functional Activities Questionnaire (FAQ) score consistent with no to minimal functional impairment

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

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.

Trial Timeline

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

Treatment Details

Interventions

• Remternetug (Other)

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.

Participant Groups

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

Findings from Research

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]

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]

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 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]

References

1. England pubmed.ncbi.nlm.nih.gov

Pharmacotherapeutic combinations for the treatment of Alzheimer's disease. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Treatment of Alzheimer disease. [2014]

3. United States pubmed.ncbi.nlm.nih.gov

Donanemab (LY3002813) dose-escalation study in Alzheimer's disease. [2022]

4. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Clinical experience of the use of memantal in patients with moderate and severe Alzheimer's disease]. [2018]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Memantine (Ebixa) in clinical practice - results of an observational study. [2013]