Georgia Memory Net Anti-Amyloid Monoclonal Antibody Registry

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

Inclusion Criteria:

1. Age 50-90, inclusive
2. Diagnosis: Mild Cognitive Impairment (MCI) or mild AD dementia with positive cerebrospinal fluid (CSF) or amyloid PET
3. 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
4. MRI brain within last year and no exclusionary criteria
5. 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
6. Informant/care partner/family available to attend follow-up visits to provide information regarding patient's cognitive and functional abilities
7. 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 Criteria:

1. Any contraindication to MRI
2. 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.
3. Seizure within the past 6 months or history of refractory epilepsy.
4. Unstable severe psychiatric illness in past 6 months
5. History of bleeding disorder, blood clotting, or clinically significant abnormal results on coagulation profile (platelet count \<50,000; INR \>1.5)
6. Uncontrolled diabetes (HgbA1c \>9%)
7. Uncontrolled hypertension
8. History of unstable angina, myocardial infarction (MI), advanced heart failure, or clinically significant conduction abnormalities within past year.
9. End stage renal disease
10. 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)
11. Systemic illness or serious infection, e.g., pneumonia, sepsis, Coronavirus disease 2029 (COVID-19), in past 30 days
12. Immunological disease requiring immunosuppression, immunoglobulins, monoclonal antibodies, or plasmapheresis
13. Exclude if breastfeeding or if female patients of childbearing potential unable to practice highly effective contraception
14. History of severe allergic or anaphylactic reactions or hypersensitivity to inactive ingredients (arginine hydrochloride, histidine, histidine hydrochloride monohydrate, polysorbate 80)

Conditions2

Locations8 sites

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