RecruitingNCT05999084

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

Sponsor

Emory University

Enrollment

735 participants

Start Date

Mar 6, 2025

Study Type

OBSERVATIONAL

Conditions

Alzheimer Disease

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.

Eligibility

Min Age: 50 YearsMax Age: 90 Years

Plain Language Summary

Simplified for easier understanding

This registry tracks patients in Georgia who are receiving newer Alzheimer's treatments called anti-amyloid antibodies (drugs that target the abnormal protein buildup in the brain associated with Alzheimer's disease) to monitor real-world outcomes and safety. **You may be eligible if...** - You are between 50 and 90 years old - You have been diagnosed with mild cognitive impairment (MCI) or mild Alzheimer's dementia - A brain scan (PET scan) or spinal fluid test has confirmed the presence of amyloid plaques in your brain - Your cognitive scores fall within acceptable ranges (MMSE ≥ 22 or MoCA ≥ 16) - You can still manage basic daily activities independently - Your recent brain MRI and blood tests show no major concerns **You may NOT be eligible if...** - Your cognitive impairment is moderate to severe - Amyloid in the brain has not been confirmed by testing - You have blood-thinning medications or other conditions that increase risk of brain bleeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAnti-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_PRODUCTStandard of Care

The standard of care, other than treatment with anti-amyloid mAbs, provided at the study clinics.