Lecanemab for Alzheimer's Disease

(DIAN-TU Trial)

Not currently recruiting at 8 trial locations

Overseen By Sarah Berman

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Washington University School of Medicine

Must be taking: Anti-amyloid therapy

Must not be taking: Full anticoagulation, Dual antiplatelet

Disqualifiers: Pregnancy, Cancer, Uncontrolled hypertension, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: Minimum of 5 years

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests lecanemab, a treatment for Alzheimer's disease, specifically targeting individuals with the genetic form known as dominantly inherited Alzheimer's disease (DIAD). Researchers aim to determine if lecanemab can remove amyloid plaques from the brain, potentially slowing or delaying the disease's progression. Participants should have previously taken part in a related study and be willing to continue anti-amyloid therapy. This trial is for those who can undergo regular MRI scans and meet specific health criteria. As a Phase 3 trial, it represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment for Alzheimer's.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on full anticoagulation or high-dose antiplatelet therapy, you may not be eligible to participate.

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

Studies have shown that lecanemab is generally well-tolerated by patients with early Alzheimer's disease. In one study, no deaths were directly related to lecanemab during the main research phase. However, nine deaths occurred during the follow-up period, but these were not directly linked to the treatment. Over three years, lecanemab slowed the decline in thinking and memory skills in patients. The FDA approved lecanemab in 2023 to slow the progression of Alzheimer's disease, indicating it is considered safe to use. However, the FDA recommends extra MRI scans for patients using lecanemab to catch any potential side effects early. Overall, lecanemab has shown promise in treating Alzheimer's but should be used with careful medical supervision. ^{1 2 3 4 5}

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

Most treatments for Alzheimer's disease, like donepezil and memantine, aim to manage symptoms rather than targeting the disease's progression. But lecanemab works differently, focusing on reducing amyloid-beta plaques in the brain, which are thought to be a main driver of Alzheimer's disease. This is a new mechanism of action, offering hope for slowing down the disease itself rather than just alleviating symptoms. Researchers are excited about lecanemab because it has the potential to fundamentally alter the course of Alzheimer's by addressing one of its root causes.

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

Research shows that lecanemab, the investigational treatment in this trial, can lower levels of amyloid, a protein linked to Alzheimer's disease, and help slow the decline in thinking and daily activities compared to not taking the drug. In earlier studies, 64% of patients either improved or did not worsen in their daily activities, and 58% experienced overall improvement. The FDA has confirmed lecanemab as a safe and effective treatment for Alzheimer's. Real-world experiences also indicate its safe use in patients with early-stage Alzheimer's. These findings support lecanemab's potential in treating Alzheimer's disease. ^{2 3 6 7 8}

Who Is on the Research Team?

Randall J Bateman, MD

Principal Investigator

Washington University School of Medicine

Are You a Good Fit for This Trial?

This trial is for individuals with a genetic form of Alzheimer's disease (DIAD) who were previously part of the DIAN-TU-001 study. Participants must carry specific mutations linked to early-onset Alzheimer's and are willing to undergo treatment with lecanemab.

Inclusion Criteria

My veins are suitable for receiving medication and monitoring.

Previously participated in the DIAN-TU-001 gantenerumab OLE period

Co-enrollment in the DIAN Observational Study (DIAN Obs, NCT00869817) and willing to complete DIAN Obs procedures and assessments

Exclusion Criteria

I have seizures that are not controlled by medication.

I do not have any other active cancers that could affect this study.

More than 20 ARIA-H MCH

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive open-label lecanemab administered intravenously approximately every 2 weeks

Minimum of 5 years

Bi-weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year

Annual assessments

Open-label extension (optional)

Participants may opt into continuation of treatment long-term

Long-term

What Are the Treatments Tested in This Trial?

Interventions

• lecanemab

Trial Overview The study tests if lecanemab can remove amyloid plaques in the brain, which are associated with Alzheimer's, and examines its impact on delaying symptoms onset and slowing down disease progression compared to those not receiving it.

How Is the Trial Designed?

Group I: lecanemab Experimental Treatment 1 Intervention

Starting at Week 0, participants will receive open-label lecanemab administered intravenously approximately every 2 weeks for a minimum of 5 years utilizing a common close design.

lecanemab is already approved in United States, China for the following indications:

Approved in United States as Leqembi for:

• Alzheimer's disease in the earliest symptomatic stages

Approved in China as 乐意保 (LEQEMBI) for:

• Mild cognitive impairment due to Alzheimer’s disease and mild AD dementia

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+

Eisai Inc.

Industry Sponsor

Trials

524

Recruited

161,000+

Founded

Eisai Inc. was established in 1995 as the U.S. subsidiary of Eisai Co., Ltd.

Headquarters

Woodcliff Lake, NJ, USA

Known For

Neurology and Oncology

Top Products

Aricept (donepezil), Lenvima (lenvatinib), Leqembi (lecanemab), Halaven (eribulin)

Lynn Kramer

Eisai Inc.

Chief Medical Officer since 2019

MD

Tatsuyuki Yasuno

Eisai Inc.

Chief Executive Officer since 2023

MBA from Kellogg School of Management, Northwestern University; Bachelor of Political Science from Waseda University

Published Research Related to This Trial

Lecanemab has shown promise in treating early Alzheimer's disease, demonstrating a significant reduction in clinical decline among participants in the study.

The study involved a large cohort, providing robust evidence for lecanemab's efficacy, although specific details on the number of subjects and duration were not provided in the overview.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evidence for lecanemab in early Alzheimer's disease. [2023]

Lecanemab, an IgG1 antibody targeting amyloid-β, received its first approval for treating Alzheimer's disease in the USA on January 6, 2023, specifically for patients with mild cognitive impairment or mild dementia who have confirmed amyloid beta pathology.

The safety and effectiveness of lecanemab have only been established for the specific patient population studied in clinical trials, and there is no data on its use in earlier or later stages of Alzheimer's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lecanemab: First Approval. Hoy, SM.[2023]

Lecanemab, a humanized monoclonal antibody, significantly reduces brain amyloid levels and leads to moderate improvements in cognitive function in Alzheimer's patients, as shown in the Clarity AD phase III trial with 18 months of treatment.

While lecanemab demonstrates efficacy in slowing cognitive decline, it is associated with adverse events such as infusion-related reactions (26.4%) and amyloid-related imaging abnormalities (12.6%), raising concerns about its administration and monitoring requirements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lecanemab: A Humanized Monoclonal Antibody for the Treatment of Early Alzheimer Disease. Park, J., Simpson, C., Patel, K.[2023]

Lecanemab is approved for early Alzheimer's disease treatment and its use in real-world settings requires careful adherence to safety guidelines, particularly monitoring for adverse events like amyloid-related imaging abnormalities (ARIA) and infusion reactions.

Patients with the APOE4 gene, especially homozygotes, are at a higher risk for ARIA, making genetic testing important for risk assessment before starting lecanemab, along with ensuring clinician preparedness for managing potential serious side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lecanemab: Appropriate Use Recommendations. Cummings, J., Apostolova, L., Rabinovici, GD., et al.[2023]

In an 18-month double-blind randomized placebo-controlled trial, lecanemab was effective in clearing amyloid-β in two-thirds of participants with mild cognitive impairment and mild dementia due to Alzheimer's disease.

Lecanemab also significantly reduced the rate of cognitive and functional decline in these individuals, suggesting its potential as a therapeutic intervention for early Alzheimer's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lecanemab reduces brain amyloid-β and delays cognitive worsening. Knopman, DS.[2023]

Lecanemab demonstrated significant efficacy in slowing cognitive decline in patients with early Alzheimer's disease, as evidenced by improvements in multiple cognitive assessment scales across four randomized controlled trials involving 3,108 participants.

While lecanemab was associated with a reduction in amyloid burden, it also presented a risk of adverse events, particularly ARIA-E and ARIA-H, indicating the need for careful monitoring during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of lecanemab for Alzheimer's disease: a systematic review and meta-analysis of randomized clinical trials. Qiao, Y., Chi, Y., Zhang, Q., et al.[2023]

Citations

1. eisai.com eisai.com/news/2025/news202554.html

Early Alzheimer's Patients Continue to Benefit from Four ... On the ADCS MCI-ADL scale, 64% of patients showed improvement or no decline, and 58% showed improvement. These findings suggest that initiating ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12117801/

Lecanemab in clinical practice: real-world outcomes in early ... However, real-world data on its efficacy and safety remain limited. The Cognitive Neurology Unit at Tel Aviv Medical Center (TLVMC) established ...

3. nejm.org nejm.org/doi/full/10.1056/NEJMoa2212948

Lecanemab in Early Alzheimer's Disease Lecanemab reduced markers of amyloid in early Alzheimer's disease and resulted in moderately less decline on measures of cognition and function than placebo at ...

4. fda.gov fda.gov/news-events/press-announcements/fda-converts-novel-alzheimers-disease-treatment-traditional-approval

FDA Converts Novel Alzheimer's Disease Treatment to ... “This confirmatory study verified that it is a safe and effective treatment for patients with Alzheimer's disease.” Alzheimer's disease is an ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40437535/

real-world outcomes in early Alzheimer's disease This real-world analysis demonstrates the feasibility and safety of Lecanemab administration for early-stage AD within a tertiary hospital ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38730496/

Updated safety results from phase 3 lecanemab study in early ... Lecanemab was generally well-tolerated in Clarity AD, with no deaths related to lecanemab in the Core study. There were 9 deaths during the OLE, ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT03887455

A Study to Confirm Safety and Efficacy of Lecanemab in ... This study will be conducted to evaluate the efficacy of lecanemab in participants with early Alzheimer's disease (EAD) by determining the superiority of ...

8. fda.gov fda.gov/drugs/drug-safety-and-availability/fda-recommend-additional-earlier-mri-monitoring-patients-alzheimers-disease-taking-leqembi-lecanemab

FDA to recommend additional, earlier MRI monitoring for ... Leqembi (lecanemab) is an amyloid beta-directed antibody that FDA approved in 2023 to slow disease progression in patients with Alzheimer's ...