Research News and Highlights

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

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Alzheimer’s Association Welcomes FDA Action Approving Leqembi Weekly Subcutaneous Maintenance Dosing

The FDA has approved weekly subcutaneous maintenance dosing of Leqembi® (lecanemab) for early Alzheimer’s disease, making it the first amyloid-clearing antibody available via autoinjector. Patients who have completed the initial 18-month course of IV infusions may now transition to self- or caregiver-administered weekly injections at home, an option that is expected to reduce treatment burden and support longer-term use.

Date Published: August 29, 2025
Publication: Alzheimer's Association

Alzheimer’s Med Donanemab Continues to Deliver Benefit at 3 Years

New results from the TRAILBLAZER-ALZ 2 long-term extension study, presented at AAIC 2025, show that donanemab continues to provide meaningful benefit up to three years in people with early symptomatic Alzheimer’s. Participants who began treatment early experienced slower cognitive and functional decline, with benefits that grew over time, and more than 75% achieved amyloid clearance within 76 weeks. Long-term follow-up showed slow re-accumulation of amyloid of about 2.5 centiloids per year, and no new safety concerns were observed. These findings underscore the importance of early diagnosis and treatment as well as continued real-world data collection through efforts like ALZ-NET, which tracks the safety and effectiveness of newly approved Alzheimer’s treatments in routine clinical practice.

Date Published: August 21, 2025
Publication: Medscape

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

More ALZ-NET news and highlights

Lead the Future of Alzheimer's Imaging — Join ALZ-NET, October 2, 2025

Early Diagnosis and Treatment of Alzheimer’s Disease, August 14, 2025

Cortechs.ai and ALZ-NET Announce Strategic Collaboration to Improve Alzheimer's Disease Care Through AI-Driven Imaging, May 19, 2025

New ‘Real World’ Data on Lecanemab Side Effects for Alzheimer’s, May 16, 2025

More and more older Americans want to know their Alzheimer's status, survey finds, April 29, 2025

American College of Radiology (ACR) and icometrix collaborate to improve the quality of care for people with Alzheimer’s disease, April 2, 2025

New Guidance for Gold-Standard Imaging Tests Assists Clinicians in Diagnosis and Management of Alzheimer’s and Other Dementia, January 8, 2025

New Clinical Practice Guideline on the Process for Diagnosing Alzheimer’s Disease or a Related Form of Cognitive Impairment or Dementia, December 23, 2024

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

FDA approves treatment for adults with Alzheimer’s disease, July 2, 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