Remternetug for Alzheimer's Disease

Recruiting at 89 trial locations

Overseen By Jeffrey A Norton

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Eli Lilly and Company

Must not be taking: Anti-amyloid immunotherapy

Disqualifiers: Unstable illnesses, Cancer, Psychiatric diagnosis, 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

1667 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the study team for guidance.

How is the drug Remternetug unique for treating Alzheimer's disease?

Remternetug is unique because it is administered both intravenously (IV) and subcutaneously (SC), offering flexibility in how the drug is given to patients. This dual administration route is not commonly seen in other Alzheimer's treatments, which typically focus on oral medications. ^{1 2 3 4 5}

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 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.

Inclusion Criteria

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

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

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

Exclusion Criteria

You have a positive result for P-tau, which shows the presence of amyloid protein in your body.

I am a woman who cannot become pregnant.

I am either male or female.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Double-blind Treatment

Participants receive remternetug or placebo via subcutaneous injection or intravenous infusion

52 weeks

Extension

Participants switch treatments; those on remternetug receive placebo and vice versa, ensuring all receive remternetug

76 weeks

Open-label Addenda

Additional participants receive open-label remternetug via subcutaneous injection or intravenous infusion

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Placebo
• Remternetug (IV)
• Remternetug (SC)

Trial Overview 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.

How Is the Trial Designed?

Group I: Remternetug (SC) Experimental Treatment 1 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 Treatment 1 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 Treatment 1 Intervention

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

Group IV: Open-Label Addenda Remternetug (IV) Experimental Treatment 1 Intervention

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

Group V: Placebo Placebo Group 1 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.

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

In a study of 202 Alzheimer's disease patients who previously did not respond to donepezil or galantamine, switching to rivastigmine resulted in a 46.3% response rate after 16 weeks, indicating it can be an effective alternative treatment.

For those who did not respond to rivastigmine alone, adding memantine led to a significant 77.9% response rate, suggesting that combination therapy is both effective and safe for improving cognitive and behavioral symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rivastigmine monotherapy and combination therapy with memantine in patients with moderately severe Alzheimer's disease who failed to benefit from previous cholinesterase inhibitor treatment. Dantoine, T., Auriacombe, S., Sarazin, M., et al.[2015]

The combination of ranimustine (MCNU) and recombinant human mutant TNF-alpha (TNF-SAM2) was found to be safe and well-tolerated in 26 patients with newly diagnosed malignant astrocytomas, with no severe or life-threatening toxicities reported.

While the treatment showed promising results in patients with anaplastic astrocytoma, leading to a median survival time of 330 weeks, it did not demonstrate improved efficacy in glioblastoma patients compared to historical controls receiving MCNU alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recombinant mutant human tumor necrosis factor-alpha (TNF-SAM2) immunotherapy with ranimustine chemotherapy and concurrent radiation therapy for malignant astrocytomas. Fukushima, T., Yamamoto, M., Oshiro, S., et al.[2012]

A phase I dose-escalation study is being conducted to evaluate the safety and maximum tolerated dose of carboplatin delivered directly into the brain using convection-enhanced delivery (CED) in patients with recurrent glioblastoma multiforme (GBM), involving 18 patients divided into 6 cohorts.

Carboplatin is chosen for this method because glioblastoma cells are sensitive to it at non-toxic levels for normal brain tissue, potentially improving treatment efficacy while minimizing side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A phase I trial of carboplatin administered by convection-enhanced delivery to patients with recurrent/progressive glioblastoma multiforme. White, E., Bienemann, A., Taylor, H., et al.[2021]

Citations

1. India pubmed.ncbi.nlm.nih.gov

Rivastigmine monotherapy and combination therapy with memantine in patients with moderately severe Alzheimer's disease who failed to benefit from previous cholinesterase inhibitor treatment. [2015]

2. Greece pubmed.ncbi.nlm.nih.gov

Recombinant mutant human tumor necrosis factor-alpha (TNF-SAM2) immunotherapy with ranimustine chemotherapy and concurrent radiation therapy for malignant astrocytomas. [2012]

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

A phase I trial of carboplatin administered by convection-enhanced delivery to patients with recurrent/progressive glioblastoma multiforme. [2021]

4. New Zealand pubmed.ncbi.nlm.nih.gov

ROS generation and autophagosome accumulation contribute to the DMAMCL-induced inhibition of glioma cell proliferation by regulating the ROS/MAPK signaling pathway and suppressing the Akt/mTOR signaling pathway. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Neurocognitive functioning and quality of life in patients with recurrent malignant gliomas treated on a phase Ib trial evaluating topotecan by convection-enhanced delivery. [2020]