Georgia Memory Net Anti-Amyloid Monoclonal Antibody Registry

RecruitingOBSERVATIONAL
Enrollment

735

Participants

Timeline

Start Date

March 6, 2025

Primary Completion Date

July 31, 2028

Study Completion Date

July 31, 2028

Conditions
Alzheimer Disease
Interventions
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.

Trial Locations (8)

30303

RECRUITING

Georgia Memory Net Memory Assessment Clinic - Atlanta, Atlanta

30322

RECRUITING

Emory Clinic, Atlanta

30474

RECRUITING

Georgia Memory Net Memory Assessment Clinic - Vidalia, Vidalia

30501

RECRUITING

Georgia Memory Net Memory Assessment Clinic - Gainesville, Gainesville

30912

RECRUITING

Georgia Memory Net Memory Assessment Clinic - Augusta, Augusta

31206

RECRUITING

Georgia Memory Net Memory Assessment Clinic - Macon, Macon

31406

RECRUITING

Georgia Memory Net Memory Assessment Clinic - Savannah, Savannah

31707

RECRUITING

Georgia Memory Net Memory Assessment Clinic - Albany, Albany

All Listed Sponsors
collaborator

Centers for Medicare and Medicaid Services

FED

lead

Emory University

OTHER