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

Official 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.

Study Design

• Study Type: OBSERVATIONAL
• Enrollment: 735 participants

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 addit
• COMBINATION_PRODUCT: Standard of Care — The standard of care, other than treatment with anti-amyloid mAbs, provided at the study clinics.

Primary Outcomes

• Change in Quick Dementia Rating System (QDRS) Score (Baseline and every 6 months until end of study (up to 5 years))
• Montreal Cognitive Assessment (MoCA) Score (Baseline and every 6 months until end of study (up to 5 years))
• Change in Functional Activities Questionnaire (FAQ) Score (Baseline and every 6 months until end of study (up to 5 years))
• Change in Lawton-Brody Activities of Daily Living (ADL) Physical Self-Maintenance Scale (PSMS) Score (Baseline and every 6 months until end of study (up to 5 years))
• Change in Lawton-Brody Instrumental Activities of Daily Living (IADL) Scale Score (Baseline and every 6 months until end of study (up to 5 years))

Secondary Outcomes

• Change in Care Needs Assessment Tool (CNAT) Score (Baseline and every 6 months until end of study (up to 5 years))
• Change in Zarit Burden Interview Score (Baseline and every 6 months until end of study (up to 5 years))
• Change in Patient-Reported Outcomes Measurement Information System Global Health (PROMIS 10) Score (Baseline and every 6 months until end of study (up to 5 years))

Trial Locations

• Georgia Memory Net Memory Assessment Clinic - Albany, Albany, Georgia, United States
• Georgia Memory Net Memory Assessment Clinic - Atlanta, Atlanta, Georgia, United States
• Emory Clinic, Atlanta, Georgia, United States
• Georgia Memory Net Memory Assessment Clinic - Augusta, Augusta, Georgia, United States
• Georgia Memory Net Memory Assessment Clinic - Gainesville, Gainesville, Georgia, United States
• Georgia Memory Net Memory Assessment Clinic - Macon, Macon, Georgia, United States
• Georgia Memory Net Memory Assessment Clinic - Savannah, Savannah, Georgia, United States
• Georgia Memory Net Memory Assessment Clinic - Vidalia, Vidalia, Georgia, United States

More Alzheimer Disease Trials

View all Alzheimer Disease clinical trials