Georgia Memory Net Anti-Amyloid Monoclonal Antibody Registry for Alzheimer's Disease

This registry is observing patients with mild cognitive impairment (MCI) or mild Alzheimer's disease (AD) dementia who are receiving anti-amyloid monoclonal antibodies (mAbs) like lecanemab. These medications work by targeting amyloid, a protein thought to contribute to Alzheimer's. You might be eligible if you are between 50 and 90 years old, have a confirmed diagnosis of MCI or mild AD dementia (with positive cerebrospinal fluid or amyloid PET scan), and meet certain cognitive and functional scores. The study aims to understand how these treatments perform in a real-world setting by tracking changes in your memory, thinking, and daily activities over up to five years. The current recruitment status is unclear, and the study plans to enroll 735 participants.

Study design
This is an observational study, meaning researchers will collect information from patients receiving standard care, rather than assigning treatments. It aims to enroll 735 participants.
What's involved
You would receive infusions of lecanemab every two weeks, as indicated by FDA labeling. Your memory, thinking, and daily activities will be assessed at the start and every six months for up to five years.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to five years, with assessments every six months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05999084

Georgia Memory Net Anti-Amyloid Monoclonal Antibody Registry

Enrolling by Invitation
Not specifiedAges 50–90Observational
Emory University
~735 participants
Updated 2026-07-10 on ClinicalTrials.gov
What's tested:Anti-amyloid Monoclonal Antibodies (mAbs)Standard of Care

At a glance

Recruiting sites
0 of 8 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Quick Dementia Rating System (QDRS) Score
Measured over Baseline and every 6 months until end of study (up to 5 years)
+4 more outcomes measured
Alzheimer Disease
8 sites across 1 states
Georgia8
  • James J Lah, MD, PhD · PRINCIPAL_INVESTIGATOR · Emory University

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Exclusion

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)
  • Change in Quick Dementia Rating System (QDRS) ScoreBaseline and every 6 months until end of study (up to 5 years)

    The QDRS is a 10-item questionnaire assessing cognitive impairment. Items are rated on a 5-point scale where no problems = 0, slight problems = 0.5, mild problems = 1, moderate to severe problems = 2, and severe problems = 3. Total scores range from 0 to 30 and higher scores indicate increased cognitive impairment.

  • Montreal Cognitive Assessment (MoCA) ScoreBaseline and every 6 months until end of study (up to 5 years)

    MoCA is an instrument to screen for mild cognitive dysfunction, assessing the cognitive domains of attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation. Total scores range from 0 to 30 with higher scores indicating better cognitive function. A normal score is considered to be 26 or higher.

  • Change in Functional Activities Questionnaire (FAQ) ScoreBaseline and every 6 months until end of study (up to 5 years)

    Instrumental activities of daily living are assessed with the Functional Activities Questionnaire (FAQ). The FAQ includes 10 items which are scored on a scale from 0 to 3 where 0 = normal and 3 = dependent. Total scores range from 0 to 30 and lower scores indicate that the respondent is able to perform daily activities. A score of 9 (where the person is dependent in 3 activities) is used as a cut-point indicating impairments with functioning.

  • Change in Lawton-Brody Activities of Daily Living (ADL) Physical Self-Maintenance Scale (PSMS) ScoreBaseline and every 6 months until end of study (up to 5 years)

    Independence with tasks such as toilet behaviors, feeding, and grooming is measured with the Physical Self-Maintenance Scale (PSMS). The PSMS is a 6-item instrument with multiple options for responses, which are scored as 0 or 1. Complete independence with the activity is scored as 1 and if any sort of assistance is needed the score is 0 . Total scores range from 0 to 6 with higher scores indicating greater independence with tasks of self-maintenance.

  • Change in Lawton-Brody Instrumental Activities of Daily Living (IADL) Scale ScoreBaseline and every 6 months until end of study (up to 5 years)

    Functional independence is measured with the Instrumental Activities of Daily Living (IADL) scale. The IADL is an 8-item instrument which assesses how well the respondent can perform daily tasks of using the telephone, shopping, food preparation, housekeeping, laundry, transport, medication, and finances by rating the responses as 0 or 1. The total score for women ranges from 0 to 8 and the total score for men ranges from 0 to 5, with higher scores indicating greater independence.