Georgia Memory Net Anti-Amyloid Monoclonal Antibody Registry

NCT05999084 | Recruiting FDA Drug

• 2 other identifiers: STUDY000064752023P006262
• Study Type: observational
• Target: 735
• Locations: 1 country
• Sites: 8

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 Georgia Memory Net Memory Assessment Clinics.

Conditions

Alzheimer Disease

Keywords

Monoclonal antibodies; Amyloid; Mild Cognitive Impairment; Lecanemab; Leqembi

Outcome Measures

Primary Outcomes (5)

• Change in Quick Dementia Rating System (QDRS) Score

  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.

  Baseline and every 6 months until end of study (up to 5 years)

• Montreal Cognitive Assessment (MoCA) Score

  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.

  Baseline and every 6 months until end of study (up to 5 years)

• Change in Functional Activities Questionnaire (FAQ) Score

  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.

  Baseline and every 6 months until end of study (up to 5 years)

• Change in Lawton-Brody Activities of Daily Living (ADL) Physical Self-Maintenance Scale (PSMS) Score

  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.

  Baseline and every 6 months until end of study (up to 5 years)

• Change in Lawton-Brody Instrumental Activities of Daily Living (IADL) Scale Score

  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.

  Baseline and every 6 months until end of study (up to 5 years)

Secondary Outcomes (3)

• Change in Care Needs Assessment Tool (CNAT) Score

  Baseline and every 6 months until end of study (up to 5 years)

• Change in Zarit Burden Interview Score

  Baseline and every 6 months until end of study (up to 5 years)

• Change in Patient-Reported Outcomes Measurement Information System Global Health (PROMIS 10) Score

  Baseline and every 6 months until end of study (up to 5 years)

Study Arms (3)

Anti-amyloid Monoclonal Antibodies (mAbs)

Patients with Mild Cognitive Impairment (MCI) or mild AD dementia who are receiving treatment with anti-amyloid mAbs, per standard of care. Patients seen in the Emory and GMN MACs are evaluated with standard instruments for cognitive and functional abilities.

Drug: Anti-amyloid Monoclonal Antibodies (mAbs)

Historical Comparator Group

Available historical data from biomarker-confirmed patients with MCI or mild dementia due to AD who have been followed in the Emory Cognitive Neurology Clinic will serve as a comparator group. Patients seen in the Emory and GMN MACs are evaluated with standard instruments for cognitive and functional abilities.

Combination Product: Standard of Care

Caregivers of Patients Receiving Anti-amyloid Monoclonal Antibodies (mAbs)

Caregivers of patients with Mild Cognitive Impairment (MCI) or mild AD dementia who are receiving treatment with anti-amyloid mAbs, per standard of care. Caregivers of patients seen in the Emory and GMN MACs are evaluated with standard instruments for cognitive and functional abilities.

Drug: Anti-amyloid Monoclonal Antibodies (mAbs)

Interventions

Anti-amyloid Monoclonal Antibodies (mAbs) DRUG

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.

Also known as: lecanemab

Anti-amyloid Monoclonal Antibodies (mAbs); Caregivers of Patients Receiving Anti-amyloid Monoclonal Antibodies (mAbs)

Standard of Care COMBINATION_PRODUCT

The standard of care, other than treatment with anti-amyloid mAbs, provided at the study clinics.

Historical Comparator Group

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study includes patients receiving care through the Emory Cognitive Neurology Clinic and Georgia Memory Net (GMN) clinics, and their caregivers.

You may qualify if:

• 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
• 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

You may not qualify if:

• Any contraindication to MRI
• 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

Sponsors & Collaborators

• Emory University: lead
• Centers for Medicare and Medicaid Services: collaborator

Study Sites (8)

Georgia Memory Net Memory Assessment Clinic - Albany

Albany, Georgia, 31707, United States

RECRUITING

Georgia Memory Net Memory Assessment Clinic - Atlanta

Atlanta, Georgia, 30303, United States

RECRUITING

Emory Clinic

Atlanta, Georgia, 30322, United States

RECRUITING

Georgia Memory Net Memory Assessment Clinic - Augusta

Augusta, Georgia, 30912, United States

RECRUITING

Georgia Memory Net Memory Assessment Clinic - Gainesville

Gainesville, Georgia, 30501, United States

RECRUITING

Georgia Memory Net Memory Assessment Clinic - Macon

Macon, Georgia, 31206, United States

RECRUITING

Georgia Memory Net Memory Assessment Clinic - Savannah

Savannah, Georgia, 31406, United States

RECRUITING

Georgia Memory Net Memory Assessment Clinic - Vidalia

Vidalia, Georgia, 30474, United States

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease; Cognitive Dysfunction

Interventions

lecanemab; Standard of Care

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• James J Lah, MD, PhD

  Emory University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

James J Lah, MD, PhD

CONTACT

404-727-3509; jlah@emory.edu

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 13, 2023
• First Posted: August 21, 2023
• Study Start: March 6, 2025
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: March 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be made publicly available upon completion of this study and initial publication of findings from this study. Earlier access may be provided to the Centers for Medicare \& Medicaid Services (CMS) or other groups who demonstrate a legitimate need for access to data.
• Access Criteria: Data may be made available on request and at the discretion of the PI to CMS, other federal agencies, academic organizations, and other legitimate researchers. Data will be available for sharing for the purposes of outcome studies to evaluate the benefits and risks associated with use of lecanemab. Requests can be submitted to Georgia Memory Net (GMN) and the PI. Data request form will be made accessible on the GMN web site.

Locations

US (8)