735
Participants
Start Date
March 6, 2025
Primary Completion Date
July 31, 2028
Study Completion Date
July 31, 2028
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.
Standard of Care
The standard of care, other than treatment with anti-amyloid mAbs, provided at the study clinics.
RECRUITING
Georgia Memory Net Memory Assessment Clinic - Atlanta, Atlanta
RECRUITING
Emory Clinic, Atlanta
RECRUITING
Georgia Memory Net Memory Assessment Clinic - Vidalia, Vidalia
RECRUITING
Georgia Memory Net Memory Assessment Clinic - Gainesville, Gainesville
RECRUITING
Georgia Memory Net Memory Assessment Clinic - Augusta, Augusta
RECRUITING
Georgia Memory Net Memory Assessment Clinic - Macon, Macon
RECRUITING
Georgia Memory Net Memory Assessment Clinic - Savannah, Savannah
RECRUITING
Georgia Memory Net Memory Assessment Clinic - Albany, Albany
Centers for Medicare and Medicaid Services
FED
Emory University
OTHER