Research News and Highlights

Explore news, updates and cutting-edge research related to real-world data and ALZ-NET.

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ALZ-NET and Eisai Inc. to Collect Real-World Data to Support Postmarketing Requirements for LEQEMBI ® (lecanemab-irmb)

As with all therapies in this class, there is an FDA postmarketing requirement (PMR) for a registry-based study to evaluate clinical safety outcomes. Eisai Inc.’s PMR study of LEQEMBI® (lecanemab-irmb) is expected to begin in early 2025 and will last ten years. Eisai Inc. will conduct a registry-based, prospective, observational study to evaluate clinical safety outcomes among early Alzheimer’s patients. ALZ-NET is collaborating with Eisai Inc. on an ALZ-NET-affiliated study that will collect real-world data to support the FDA postmarketing requirements.

Date Published: October 3, 2024
Publication: Alzheimer’s Association

Alzheimer’s Association Workgroup Publishes Biology-Based Criteria for Diagnosis and Staging of Alzheimer’s Disease

A workgroup convened by the Alzheimer’s Association has published revised criteria for the diagnosis and staging of Alzheimer’s disease based on the biology of the disease and reflecting recent advancements in Alzheimer’s research, diagnostics and treatment. The revised criteria define Alzheimer’s disease as a biological process that begins with the appearance of Alzheimer’s-related changes that happen in the brain before people exhibit memory and thinking problems. The 2024 update includes an updated biomarker classification system that includes blood-based biomarkers and a revised disease staging system.

Date Published: June 27, 2024
Publication: Alzheimer’s Association

FDA approves treatment for adults with Alzheimer’s disease

On July 2, 2024, the U.S. Food and Drug Administration (FDA) approved Kisunla™ (donanemab), an amyloid beta-targeting antibody, for the treatment of Alzheimer’s disease. Treatment with Kisunla should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was studied in the clinical trials.

Date Published: July 2, 2024
Publication: FDA

More ALZ-NET news and highlights

Two New Deaths on Leqembi Highlight Need to Better Manage ARIA, August 16, 2024

FDA Approves New-Generation Acetylcholinesterase Inhibitor ALPHA-1062 for Mild-to-Moderate Alzheimer Disease, July 29, 2024

Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer’s Disease (AD), January 31, 2024

Radiology Takes on Alzheimer's Disease, October 4, 2023

Isaac Health joins ALZ-NET as a participating telehealth site, September 6, 2023

FDA Converts Novel Alzheimer’s Disease Treatment to Traditional Approval (lecanemab), July 6, 2023

FDA Approves First Drug to Treat Agitation Symptoms Associated with Dementia due to Alzheimer’s Disease (brexpiprazole), May 11, 2023

Emerging Therapies for Early Alzheimer’s Disease, April 3, 2023

Experts reframe ‘clinical meaningfulness’ in Alzheimer’s, February 7, 2023

FDA Grants Accelerated Approval for Alzheimer’s Disease Treatment (lecanemab), January 6, 2023

Alzheimer’s Association Launches ALZ-NET Registry for Study of New Treatments for Alzheimer's Disease in Real-World Setting, August 2, 2022

Alzheimer’s Association Launches ALZ-NET: A Long-Term Data Collection and Sharing Network for New Treatments, August 1, 2022

Working Towards a World Without Alzheimer’s and All Other Dementia, November 26, 2021

Alzheimer’s Association announces national data registry for quick, transparent data sharing, November 12, 2021

National Alzheimer Disease Registry Announced to Collect Clinical Practice Data, November 12, 2021

Publications from ALZ-NET

ALZ-NET: Using Real World Evidence to Inform the Future of Alzheimer’s Treatment and Care
Published: December 2022

Alzheimer’s Association launches ALZ-NET: A long-term data collection and sharing network for new treatment
Published: September 2022

More news from the Alzheimer’s Association

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