NCT05999084Enrolling by invitation
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
Source: ClinicalTrials.gov · Last updated 10 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Study type
- Observational
- Enrollment
- 735 (estimated)
- First submitted
- 13 Aug 2023
- Start date
- 6 Mar 2025
- Primary completion date
- Jul 2028
- Lead sponsor
- Emory University
- Diseases
- Alzheimer disease
- NCT number
- NCT05999084
What you commit to
- Study type: Observational
- Planned participants: 735
- From 6 Mar 2025 to the primary completion date, Jul 2028
- 8 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- 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)
Other illness
- Seizure within the past 6 months or history of refractory epilepsy.
- Unstable severe psychiatric illness in past 6 months
- 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
- 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
- History of severe allergic or anaphylactic reactions or hypersensitivity to inactive ingredients (arginine hydrochloride, histidine, histidine hydrochloride monohydrate, polysorbate 80)
Lab values
- History of bleeding disorder, blood clotting, or clinically significant abnormal results on coagulation profile (platelet count \<50,000; INR \>1.5)
Other
- Any contraindication to MRI
- Exclude if breastfeeding or if female patients of childbearing potential unable to practice highly effective contraception
Who the study is looking for
- 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
Age in the registry: 50 years to 90 years · Sex: All · Does not accept healthy volunteers
Sites (8)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Georgia Memory Net Memory Assessment Clinic - Albany Coordinator of this site? Confirm its status | Albany | United States | Unknown status |
| Georgia Memory Net Memory Assessment Clinic - Atlanta Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| Emory Cognitive Neurology Clinic at the Emory Brain Health Center Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| Georgia Memory Net Memory Assessment Clinic - Augusta Coordinator of this site? Confirm its status | Augusta | United States | Unknown status |
| Georgia Memory Net Memory Assessment Clinic - Gainesville Coordinator of this site? Confirm its status | Gainesville | United States | Unknown status |
| Georgia Memory Net Memory Assessment Clinic - Macon Coordinator of this site? Confirm its status | Macon | United States | Unknown status |
| Georgia Memory Net Memory Assessment Clinic - Savannah Coordinator of this site? Confirm its status | Savannah | United States | Unknown status |
| Georgia Memory Net Memory Assessment Clinic - Vidalia Coordinator of this site? Confirm its status | Vidalia | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.