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

Inclusion Criteria10

Age 50-90, inclusive
Diagnosis: Mild Cognitive Impairment (MCI) or mild AD dementia with positive cerebrospinal fluid (CSF) or amyloid PET
Objective measurement of baseline cognition and function within past 3 months:
Cognitive: Mini-Mental State Examination (MMSE) ≥ 22, MoCA ≥ 16
Function: Independence in basic ADLs
Function: FAQ ≤ 9 may justify inclusion with lower cognitive score if felt to be impacted by prominent language impairment or other factors affecting score
MRI brain within last year and no exclusionary criteria
Complete blood count (CBC), comprehensive metabolic panel (CMP), B12, thyroid stimulating hormone (TSH), prothrombin time (PT), partial thromboplastin time (PTT), and International Normalized Ratio (INR) without clinically significant abnormality
Informant/care partner/family available to attend follow-up visits to provide information regarding patient's cognitive and functional abilities
Agree to MRI, PET, and testing clinical diagnostic requirements and drug label / FDA recommendations to determine drug eligibility and appropriateness, including Apolipoprotein E (APOE) testing

Exclusion Criteria18

Any contraindication to MRI
Acute or sub-acute hemorrhage
Prior macro hemorrhage (\>1 cm), subarachnoid hemorrhage, or known aneurysm
\>4 microhemorrhages
Superficial siderosis
Any finding that might be a contributing cause of the subject's dementia that could pose a risk to the subject or prevent safety MRIs.
Seizure within the past 6 months or history of refractory epilepsy.
Unstable severe psychiatric illness in past 6 months
History of bleeding disorder, blood clotting, or clinically significant abnormal results on coagulation profile (platelet count \<50,000; INR \>1.5)
Uncontrolled diabetes (HgbA1c \>9%)
Uncontrolled hypertension
History of unstable angina, myocardial infarction (MI), advanced heart failure, or clinically significant conduction abnormalities within past year.
End stage renal disease
Receiving active treatment for cancer (e.g., chemotherapy, biologics, or radiation therapy) with exceptions for maintenance therapies for cancer in remission (e.g., anti-estrogen for breast cancer)
Systemic illness or serious infection, e.g., pneumonia, sepsis, Coronavirus disease 2029 (COVID-19), in past 30 days
Immunological disease requiring immunosuppression, immunoglobulins, monoclonal antibodies, or plasmapheresis
Exclude if breastfeeding or if female patients of childbearing potential unable to practice highly effective contraception
History of severe allergic or anaphylactic reactions or hypersensitivity to inactive ingredients (arginine hydrochloride, histidine, histidine hydrochloride monohydrate, polysorbate 80)

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.