NCT05999084

Georgia Memory Net Anti-Amyloid Monoclonal Antibody Registry

Georgia Memory Net Center for Medicare and Medicaid Services Registry for Anti-Amyloid Monoclonal Antibody Coverage With Evidence Development

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 735 (estimated)
• Sponsor: Emory University · Academic / Other
• Sex: All
• Age: 50 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this registry is to compile information on patients who are receiving FDA-approved anti-amyloid mAbs in the course of their clinic visits in the Emory Cognitive Neurology Clinic and in Georgia Memory Net Memory Assessment Clinics.

Detailed description

Alzheimer's disease is a devastating neurodegenerative illness impacting millions of Americans including patients and caregivers. Treatments have been limited to symptomatic therapies leading to the pervasive sentiment that 'nothing can be done'; however, recent advances in the field have created excitement and hope for patients, families, and healthcare providers. On 6 January 2023, the anti-amyloid monoclonal antibody (mAb) lecanemab received accelerated approval from the Food and Drug Administration (FDA). A similar medication, donanemab, also recently demonstrated positive results in a large trial. Despite the positive trials, questions remain about anti-amyloid mAbs efficacy as well as how they will perform in a real-world setting. The Centers for Medicare \& Medicaid Services (CMS) released a National Coverage Analysis (NCA) Memo with a framework for deploying anti-amyloid mAbs in a way that improves understanding of benefit and harm. This registry will be managed through Georgia Memory Net (GMN), an initiative that was launched in 2018 to build statewide capacity for early and specific diagnosis of Alzheimer's disease and related dementias (ADRD), improve patient and caregiver support, and provide access to emerging disease modifying therapies. The GMN supports Memory Assessment Clinics (MACs) geographically distributed at 7 sites around the state with common data elements modeled on best practices developed in the Emory University Cognitive Neurology Memory Assessment Clinic over the past 25 years. The GMN infrastructure and care model provides an optimal real-world testing ground for evidence development on the effectiveness, safety, and appropriate use of anti-amyloid mAbs in the Medicare population. The clinical data for patients treated with anti-amyloid mAbs will be compared to historical clinical data from comparable patients who were seen in GMN clinics prior to availability of anti-amyloid mAbs. Patients in the registry will be followed for the duration of their initial treatment as specified by FDA for specific anti-amyloid monoclonal antibody and subsequent maintenance treatment which is currently unspecified. The objectives of this registry are to: 1. Monitor clinical use of FDA approved anti-amyloid mAbs to report health outcomes for patients in broad community practice. 2. Understand how patient characteristics, treating clinicians, and clinical settings impact benefits and harms (brain hemorrhage and edema) of FDA approved anti-amyloid mAbs. 3. Define how benefits and harms of FDA approved anti-amyloid mAbs change over time.

Conditions

• Alzheimer Disease

Interventions

Type	Name	Description
DRUG	Anti-amyloid Monoclonal Antibodies (mAbs)	Infusions of lecanemab occur every 2-weeks as indicated in the FDA labeling. After 18 months of treatment, an amyloid positron emission tomography (PET) scan with FDA-approved radiotracer is performed to confirm clearance of amyloid pathology. It is anticipated that most individuals treated with lecanemab for 18 months will no longer have positive amyloid PET scans. In those instances where persistent amyloid pathology is seen, every 2-week treatment with lecanemab will be continued for an additional 6 months with repeat amyloid PET scan until amyloid clearance is achieved. If an individual has progressed to moderate or severe stages of AD dementia during the initial 18 months of treatment and amyloid PET shows failure to clear amyloid pathology, treatment will be terminated. Dosing frequency after 18 months (or after amyloid clearance) remains unclear and will need to be determined with additional evidence development.
COMBINATION_PRODUCT	Standard of Care	The standard of care, other than treatment with anti-amyloid mAbs, provided at the study clinics.

Timeline

• Start date: 2025-03-06
• Primary completion: 2028-07-01
• Completion: 2028-07-01
• First posted: 2023-08-21
• Last updated: 2026-03-11

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated drug study