Remternetug for Alzheimer's Disease

(DIAN-TU-002 Trial)

Recruiting at 41 trial locations

Overseen By Sarah Berman

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: Washington University School of Medicine

Must not be taking: Anticoagulants, Immunosuppressives, Chemotherapeutics, others

Disqualifiers: Neurologic, Psychiatric, Stroke, Substance use, others

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

Compensation: Varies

Number of Visits: Unknown

280 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a drug called remternetug to determine if it can help people with Alzheimer's disease by preventing or reversing the buildup of amyloid beta, a protein linked to the disease. Researchers are assessing participants' tolerance to the drug and examining any potential benefits or risks. The trial targets individuals with normal memory and thinking skills who carry genetic mutations that increase their risk for Alzheimer's disease. Participants must speak and understand the trial's language and have a family member who can provide information about their condition. As a Phase 2, Phase 3 trial, this research measures the treatment's effectiveness in an initial, smaller group and represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking Alzheimer's treatment.

Will I have to stop taking my current medications?

The trial does not specify if you must stop taking your current medications. However, it mentions that participants should be on stable doses of their current medications for at least 30 days before starting the trial, except for medications taken for episodic conditions. Approved treatments for Alzheimer's and other medications may be permitted.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Previous studies have tested remternetug for safety in people with early-stage Alzheimer's disease. Results showed that participants generally tolerated the treatment well. Common side effects included headaches and dizziness, but these were not severe for most individuals. Serious side effects were rare. Research also indicated that remternetug helped reduce amyloid plaques in the brain, which are linked to Alzheimer's disease. This suggests that the treatment could be promising, though ongoing trials are still studying its long-term safety. ^{1 2 3 4 5}

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

Researchers are excited about Remternetug for Alzheimer's disease because it targets amyloid-beta plaques in the brain, which are believed to play a key role in the progression of the disease. Unlike most current treatments that focus on managing symptoms, Remternetug aims to address the underlying cause. Additionally, its potential to be more effective at earlier stages of Alzheimer's sets it apart from existing drugs that are typically used in later stages. This novel approach has the potential to slow the progression of Alzheimer's more effectively than current standard treatments.

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

Research shows that remternetug, which participants in this trial may receive, may help reduce amyloid plaques in the brain. These plaques are thought to contribute to the progression of Alzheimer's disease. Previous studies have found that treatments targeting these plaques can slow the decline in memory and thinking skills. For example, similar drugs slowed the disease by about 32% over 18 months. This evidence suggests that remternetug could be effective in treating Alzheimer's, especially in its early stages. ^{1 2 3 4 5}

Who Is on the Research Team?

Eric M McDade, DO

Principal Investigator

Washington University School of Medicine

Are You a Good Fit for This Trial?

This trial is for individuals who have a genetic form of Alzheimer's disease but do not yet show symptoms. They must carry mutations that cause the disease and are at risk of developing it. Specific details about inclusion or exclusion criteria were not provided.

Inclusion Criteria

I agree not to try to become pregnant during and shortly after the study.

I have been on stable medication for over 30 days for a condition that is not excluded from the study.

Provide written informed consent, signed, and dated by the participant and study partner, or by the participant's legally authorized representative if applicable, according to local regulations for the ICF and, if applicable, country specific ICFs

Exclusion Criteria

I am able to complete all required initial visit tests and assessments.

My brain MRI does not show significant issues like major bleeding, brain damage, or aneurysms.

Any other medical condition that could be expected to progress, recur, or change to such an extent that it could bias the assessment of the clinical or mental status of the participant to a significant degree or put the participant at special risk

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Stage 1 Treatment

Participants receive remternetug or placebo to assess prevention or reversal of amyloid beta accumulation

104 weeks

Regular visits for imaging and biomarker assessments

Stage 2 Treatment

Evaluation of early anti-amyloid treatment effects on downstream biomarkers compared to control groups

192 weeks

Visits at Weeks 0, 48, 96, 144, and 192 for biomarker and cognitive assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Matching Placebo (Remternetug)
• Remternetug

Trial Overview The study tests remternetug, which might prevent or slow down Alzheimer's in people with inherited risk. It compares remternetug to a placebo (inactive substance) using brain scans and other tests to measure its effect on the disease's biomarkers.

How Is the Trial Designed?

Group I: Stage 1: Remternetug Experimental Treatment 1 Intervention

Active Remternetug- blinded

Group II: Stage 2: Remternetug Open Label Active Control 1 Intervention

Open label will start after last dose of Stage 1

Group III: Stage 1: Matching placebo (Remternetug) Placebo Group 1 Intervention

Matching placebo

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

Alzheimer's Association

Collaborator

Trials

103

Recruited

44,300+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Eli Lilly and Company

Industry 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

GHR Foundation

Collaborator

Trials

1

Recruited

280+

Private Donors

Collaborator

Trials

1

Recruited

280+

Published Research Related to This Trial

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]

A six-month study involving 50 patients with mild to moderate Alzheimer's disease found that both original memantine and the generic version (memantal) showed similar efficacy in improving cognitive functions and neuropsychiatric symptoms.

There were no significant differences in safety or effectiveness between the two medications, indicating that the generic memantal is a viable alternative to the original memantine for treating dementia in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[A comparison of the efficacy and safety of memantal and original memantine in the treatment of mild and moderate dementia in Alzheimer's disease]. Shiryaev, OY., Shapovalov, DL., Polozova, TM., et al.[2018]

In a 24-week study involving 470 patients with mild to moderate Alzheimer's disease, memantine (20 mg/day) demonstrated significant improvements in cognitive function compared to placebo, particularly at weeks 12 and 18.

Memantine was well tolerated, with side effects similar to those experienced by patients on placebo, indicating a favorable safety profile for its use in treating Alzheimer's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Memantine treatment in patients with mild to moderate Alzheimer's disease: results of a randomised, double-blind, placebo-controlled 6-month study. Bakchine, S., Loft, H.[2022]

In a study involving 403 patients with mild to moderate Alzheimer's disease, memantine (20 mg/day) showed significant improvements in cognitive function and global status compared to placebo over 24 weeks.

The treatment was generally safe, with a slightly higher rate of discontinuations due to adverse events in the memantine group (9.5%) compared to placebo (5.0%), indicating that while memantine is effective, monitoring for side effects is important.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Memantine treatment in mild to moderate Alzheimer disease: a 24-week randomized, controlled trial. Peskind, ER., Potkin, SG., Pomara, N., et al.[2022]

Cholinesterase inhibitors are currently the only approved medications for treating cognitive deficits in Alzheimer's disease, showing efficacy in clinical trials by compensating for the loss of acetylcholine.

Antioxidant drugs like alpha-tocopherol (vitamin E) and selegiline have shown marginal benefits over placebo in slowing functional decline in patients with moderately advanced Alzheimer's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacologic approaches to cognitive deficits in Alzheimer's disease. Peskind, ER.[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.