Status:
RECRUITING
Georgia Memory Net Anti-Amyloid Monoclonal Antibody Registry
Lead Sponsor:
Emory University
Collaborating Sponsors:
Centers for Medicare and Medicaid Services
Conditions:
Alzheimer Disease
Eligibility:
All Genders
50-90 years
Brief 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 ...
Detailed Description
Alzheimer's disease is a devastating neurodegenerative illness impacting millions of Americans including patients and caregivers. Treatments have been limited to symptomatic therapies leading to the p...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
March 6 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 1 2028
Estimated Enrollment :
735 Patients enrolled
Trial Details
Trial ID
NCT05999084
Start Date
March 6 2025
End Date
July 1 2028
Last Update
March 10 2025
Active Locations (8)
Enter a location and click search to find clinical trials sorted by distance.
1
Georgia Memory Net Memory Assessment Clinic - Albany
Albany, Georgia, United States, 31707
2
Georgia Memory Net Memory Assessment Clinic - Atlanta
Atlanta, Georgia, United States, 30303
3
Emory Clinic
Atlanta, Georgia, United States, 30322
4
Georgia Memory Net Memory Assessment Clinic - Augusta
Augusta, Georgia, United States, 30912