Lecanemab for Alzheimer's Disease

(DIAN-TU Trial)

Recruiting at 7 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

65 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This is an open label study to treat dominantly inherited Alzheimer's disease (DIAD) mutation carrier participants from the DIAN-TU-001 gantenerumab Open Label Extension (OLE) period with lecanemab to determine the effects of amyloid removal on age of onset and clinical progression compared to external controls, if amyloid plaque as measured by amyloid PET can be fully removed in DIAD, and the effects of amyloid removal on biomarkers of disease progression.

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.

What is known about the safety of lecanemab for Alzheimer's disease?

Lecanemab has been studied for safety in people with early Alzheimer's disease. Some side effects include amyloid-related imaging abnormalities (ARIA), which are usually not serious but can be in rare cases, and infusion reactions. People taking blood thinners may have a higher risk of bleeding, and those with a specific gene (APOE4) may have a higher risk of ARIA. ^{1 2 3 4 5}

What data supports the effectiveness of the drug lecanemab for Alzheimer's disease?

Research shows that lecanemab helps clear amyloid-β (a protein linked to Alzheimer's) from the brain and slows down the worsening of memory and thinking skills in people with early Alzheimer's disease. ^{1 2 3 4 6}

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]

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, 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 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]

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]

Citations

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

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

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

Lecanemab: First Approval. [2023]

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

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

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

Lecanemab: A Humanized Monoclonal Antibody for the Treatment of Early Alzheimer Disease. [2023]

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

Safety and efficacy of lecanemab for Alzheimer's disease: a systematic review and meta-analysis of randomized clinical trials. [2023]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Lecanemab: Appropriate Use Recommendations. [2023]