Georgia Memory Net Anti-Amyloid Monoclonal Antibody Registry

Last updated: March 6, 2025
Sponsor: Emory University
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Standard of Care

Anti-amyloid Monoclonal Antibodies (mAbs)

Clinical Study ID

NCT05999084
STUDY00006475
  • Ages 50-90
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  1. Age 50-90, inclusive

  2. Diagnosis: Mild Cognitive Impairment (MCI) or mild AD dementia with positivecerebrospinal 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 tobe impacted by prominent language impairment or other factors affecting score

  1. MRI brain within last year and no exclusionary criteria

  2. Complete blood count (CBC), comprehensive metabolic panel (CMP), B12, thyroidstimulating hormone (TSH), prothrombin time (PT), partial thromboplastin time (PTT),and International Normalized Ratio (INR) without clinically significant abnormality

  3. Informant/care partner/family available to attend follow-up visits to provideinformation regarding patient's cognitive and functional abilities

  4. Agree to MRI, PET, and testing clinical diagnostic requirements and drug label / FDArecommendations to determine drug eligibility and appropriateness, includingApolipoprotein E (APOE) testing

Exclusion

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 thatcould pose a risk to the subject or prevent safety MRIs.

  1. Seizure within the past 6 months or history of refractory epilepsy.

  2. Unstable severe psychiatric illness in past 6 months

  3. History of bleeding disorder, blood clotting, or clinically significant abnormalresults on coagulation profile (platelet count <50,000; INR >1.5)

  4. Uncontrolled diabetes (HgbA1c >9%)

  5. Uncontrolled hypertension

  6. History of unstable angina, myocardial infarction (MI), advanced heart failure, orclinically significant conduction abnormalities within past year.

  7. End stage renal disease

  8. Receiving active treatment for cancer (e.g., chemotherapy, biologics, or radiationtherapy) with exceptions for maintenance therapies for cancer in remission (e.g.,anti-estrogen for breast cancer)

  9. Systemic illness or serious infection, e.g., pneumonia, sepsis, Coronavirus disease 2029 (COVID-19), in past 30 days

  10. Immunological disease requiring immunosuppression, immunoglobulins, monoclonalantibodies, or plasmapheresis

  11. Exclude if breastfeeding or if female patients of childbearing potential unable topractice highly effective contraception

  12. History of severe allergic or anaphylactic reactions or hypersensitivity to inactiveingredients (arginine hydrochloride, histidine, histidine hydrochloride monohydrate,polysorbate 80)

Study Design

Total Participants: 735
Treatment Group(s): 2
Primary Treatment: Standard of Care
Phase:
Study Start date:
March 06, 2025
Estimated Completion Date:
July 31, 2028

Study 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 pervasive sentiment that 'nothing can be done'; however, recent advances in the field have created excitement and hope for patients, families, and healthcare providers. On 6 January 2023, the anti-amyloid monoclonal antibody (mAb) lecanemab received accelerated approval from the Food and Drug Administration (FDA). A similar medication, donanemab, also recently demonstrated positive results in a large trial. Despite the positive trials, questions remain about anti-amyloid mAbs efficacy as well as how they will perform in a real-world setting. The Centers for Medicare & Medicaid Services (CMS) released a National Coverage Analysis (NCA) Memo with a framework for deploying anti-amyloid mAbs in a way that improves understanding of benefit and harm.

This registry will be managed through Georgia Memory Net (GMN), an initiative that was launched in 2018 to build statewide capacity for early and specific diagnosis of Alzheimer's disease and related dementias (ADRD), improve patient and caregiver support, and provide access to emerging disease modifying therapies. The GMN supports Memory Assessment Clinics (MACs) geographically distributed at 7 sites around the state with common data elements modeled on best practices developed in the Emory University Cognitive Neurology Memory Assessment Clinic over the past 25 years. The GMN infrastructure and care model provides an optimal real-world testing ground for evidence development on the effectiveness, safety, and appropriate use of anti-amyloid mAbs in the Medicare population.

The clinical data for patients treated with anti-amyloid mAbs will be compared to historical clinical data from comparable patients who were seen in GMN clinics prior to availability of anti-amyloid mAbs. Patients in the registry will be followed for the duration of their initial treatment as specified by FDA for specific anti-amyloid monoclonal antibody and subsequent maintenance treatment which is currently unspecified.

The objectives of this registry are to:

  1. Monitor clinical use of FDA approved anti-amyloid mAbs to report health outcomes for patients in broad community practice.

  2. Understand how patient characteristics, treating clinicians, and clinical settings impact benefits and harms (brain hemorrhage and edema) of FDA approved anti-amyloid mAbs.

  3. Define how benefits and harms of FDA approved anti-amyloid mAbs change over time.

Connect with a study center

  • Georgia Memory Net Memory Assessment Clinic - Albany

    Albany, Georgia 31707
    United States

    Active - Recruiting

  • Emory Clinic

    Atlanta, Georgia 30322
    United States

    Active - Recruiting

  • Georgia Memory Net Memory Assessment Clinic - Atlanta

    Atlanta, Georgia 30303
    United States

    Active - Recruiting

  • Georgia Memory Net Memory Assessment Clinic - Augusta

    Augusta, Georgia 30912
    United States

    Active - Recruiting

  • Georgia Memory Net Memory Assessment Clinic - Gainesville

    Gainesville, Georgia 30501
    United States

    Active - Recruiting

  • Georgia Memory Net Memory Assessment Clinic - Macon

    Macon, Georgia 31206
    United States

    Active - Recruiting

  • Georgia Memory Net Memory Assessment Clinic - Savannah

    Savannah, Georgia 31406
    United States

    Active - Recruiting

  • Georgia Memory Net Memory Assessment Clinic - Vidalia

    Vidalia, Georgia 30474
    United States

    Active - Recruiting

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