RECRUITINGOBSERVATIONAL
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
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
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
Who Should NOT Join This Trial:
1. Any contraindication to MRI
2. MRI Who Should NOT Join This Trial:
- 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
...See full criteria on ClinicalTrials.gov
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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)
Treatments Being Tested
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 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_PRODUCT
Standard of Care
The standard of care, other than treatment with anti-amyloid mAbs, provided at the study clinics.
Locations (8)
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