Georgia Memory Net Anti-Amyloid Monoclonal Antibody Registry

Description

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

Study Overview

Study Details

Study overview

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.

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

Georgia Memory Net Anti-Amyloid Monoclonal Antibody Registry

Condition
Alzheimer Disease
Intervention / Treatment

-

Contacts and Locations

Albany

Georgia Memory Net Memory Assessment Clinic - Albany, Albany, Georgia, United States, 31707

Atlanta

Georgia Memory Net Memory Assessment Clinic - Atlanta, Atlanta, Georgia, United States, 30303

Atlanta

Emory Clinic, Atlanta, Georgia, United States, 30322

Augusta

Georgia Memory Net Memory Assessment Clinic - Augusta, Augusta, Georgia, United States, 30912

Gainesville

Georgia Memory Net Memory Assessment Clinic - Gainesville, Gainesville, Georgia, United States, 30501

Macon

Georgia Memory Net Memory Assessment Clinic - Macon, Macon, Georgia, United States, 31206

Savannah

Georgia Memory Net Memory Assessment Clinic - Savannah, Savannah, Georgia, United States, 31406

Vidalia

Georgia Memory Net Memory Assessment Clinic - Vidalia, Vidalia, Georgia, United States, 30474

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 1. Any contraindication to MRI
  • 2. MRI

Ages Eligible for Study

50 Years to 90 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Emory University,

James J Lah, MD, PhD, PRINCIPAL_INVESTIGATOR, Emory University

Study Record Dates

2028-07