Georgia Memory Net Anti-Amyloid Monoclonal Antibody Registry

Enrolling by invitation

Conditions studied: Alzheimer Disease

In brief

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.

Key facts

Study ID

NCT05999084

Run by

Emory University

People needed

735

Starts

2025-03-06

Expected to finish

2028-07-01

Last updated by the study team

2026-07-10

Who can join

Age: 50 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Any contraindication to MRI
• MRI exclusion criteria:
• 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)

Where it is running

• Georgia Memory Net Memory Assessment Clinic - Albany — Albany, Georgia, United States
• Georgia Memory Net Memory Assessment Clinic - Atlanta — Atlanta, Georgia, United States
• Emory Cognitive Neurology Clinic at the Emory Brain Health Center — 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

Full record on ClinicalTrials.gov

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