Registry for patients receiving anti-amyloid monoclonal antibodies for Alzheimer's disease

Georgia Memory Net Center for Medicare and Medicaid Services Registry for Anti-Amyloid Monoclonal Antibody Coverage With Evidence Development

This study is gathering information from people with mild Alzheimer's or mild cognitive impairment who are receiving new anti-amyloid treatments to see how well they work in real life and improve support for patients and caregivers.

Quick facts

• Study type: Observational
• Enrollment: 735 (estimated)
• Ages: 50 Years to 90 Years
• Sex: All
• Sponsor: Emory University (Academic / other)
• Drugs / interventions: chemotherapy, radiation, lecanemab, donanemab
• Locations: 8 sites (Albany, Georgia and 7 other locations)
• Trial ID: NCT05999084 on ClinicalTrials.gov

What this trial studies

This registry aims to gather information on patients diagnosed with Mild Cognitive Impairment or mild Alzheimer's dementia who are receiving FDA-approved anti-amyloid monoclonal antibodies during their visits at the Emory Cognitive Neurology Clinic and Georgia Memory Net Memory Assessment Clinics. The initiative seeks to enhance understanding of the efficacy and real-world performance of these treatments, particularly following the recent approvals of lecanemab and donanemab. By compiling data from multiple sites across Georgia, the registry will support early diagnosis and improve patient and caregiver support while providing access to emerging therapies. The study will also adhere to guidelines set forth by the Centers for Medicare & Medicaid Services to evaluate the benefits and risks associated with these treatments.

Who should consider this trial

Good fit: Ideal candidates for this registry are individuals aged 50-90 with Mild Cognitive Impairment or mild Alzheimer's dementia who have positive cerebrospinal fluid or amyloid PET results.

Not a fit: Patients with severe cognitive impairment or those who do not meet the specific diagnostic criteria for Mild Cognitive Impairment or mild Alzheimer's dementia may not benefit from this registry.

Why it matters

Potential benefit: If successful, this registry could provide valuable insights into the effectiveness of anti-amyloid therapies for Alzheimer's disease, potentially leading to improved treatment strategies.

How similar studies have performed: Other studies involving anti-amyloid monoclonal antibodies have shown promising results, but this registry approach is designed to gather real-world data, making it a novel initiative.

Eligibility criteria

Inclusion Criteria:

1. Age 50-90, inclusive
2. Diagnosis: Mild Cognitive Impairment (MCI) or mild AD dementia with positive cerebrospinal 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 to be impacted by prominent language impairment or other factors affecting score
4. MRI brain within last year and no exclusionary criteria
5. 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
6. Informant/care partner/family available to attend follow-up visits to provide information regarding patient's cognitive and functional abilities
7. 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 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 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)

Where this trial is running

Albany, Georgia and 7 other locations

• Georgia Memory Net Memory Assessment Clinic - Albany — Albany, Georgia, United States (Recruiting)
• Georgia Memory Net Memory Assessment Clinic - Atlanta — Atlanta, Georgia, United States (Recruiting)
• Emory Clinic — Atlanta, Georgia, United States (Recruiting)
• Georgia Memory Net Memory Assessment Clinic - Augusta — Augusta, Georgia, United States (Recruiting)
• Georgia Memory Net Memory Assessment Clinic - Gainesville — Gainesville, Georgia, United States (Recruiting)
• Georgia Memory Net Memory Assessment Clinic - Macon — Macon, Georgia, United States (Recruiting)
• Georgia Memory Net Memory Assessment Clinic - Savannah — Savannah, Georgia, United States (Recruiting)
• Georgia Memory Net Memory Assessment Clinic - Vidalia — Vidalia, Georgia, United States (Recruiting)

Study contacts

• Principal investigator: James J Lah, MD, PhD — Emory University
• Study coordinator: James J Lah, MD, PhD

Conditions Alzheimer Disease; Monoclonal antibodies; Amyloid; Mild Cognitive Impairment; Lecanemab; Leqembi