RECRUITING

Georgia Memory Net Anti-Amyloid Monoclonal Antibody Registry

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Conditions

Alzheimer DiseaseMonoclonal antibodiesAmyloidMild Cognitive ImpairmentLecanemabLeqembi

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-11
Study Completion:2028-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05999084

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.

Ages Eligible for Study:50 Years to 90 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Age 50-90, inclusive
  2. 2. Diagnosis: Mild Cognitive Impairment (MCI) or mild AD dementia with positive cerebrospinal fluid (CSF) or amyloid PET
  3. 3. Objective measurement of baseline cognition and function within past 3 months:
  4. * Cognitive: Mini-Mental State Examination (MMSE) ≥ 22, MoCA ≥ 16
  5. * Function: Independence in basic ADLs
  6. * Function: FAQ ≤ 9 may justify inclusion with lower cognitive score if felt to be impacted by prominent language impairment or other factors affecting score
  7. 4. MRI brain within last year and no exclusionary criteria
  8. 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
  9. 6. Informant/care partner/family available to attend follow-up visits to provide information regarding patient's cognitive and functional abilities
  10. 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. 1. Any contraindication to MRI
  2. 2. MRI

Contacts and Locations

Study Contact

James J Lah, MD, PhD
CONTACT
404-727-3509
jlah@emory.edu

Principal Investigator

James J Lah, MD, PhD
PRINCIPAL_INVESTIGATOR
Emory University

Study Locations (Sites)

Georgia Memory Net Memory Assessment Clinic - Albany
Albany, Georgia, 31707
United States
Georgia Memory Net Memory Assessment Clinic - Atlanta
Atlanta, Georgia, 30303
United States
Emory Clinic
Atlanta, Georgia, 30322
United States
Georgia Memory Net Memory Assessment Clinic - Augusta
Augusta, Georgia, 30912
United States
Georgia Memory Net Memory Assessment Clinic - Gainesville
Gainesville, Georgia, 30501
United States
Georgia Memory Net Memory Assessment Clinic - Macon
Macon, Georgia, 31206
United States
Georgia Memory Net Memory Assessment Clinic - Savannah
Savannah, Georgia, 31406
United States
Georgia Memory Net Memory Assessment Clinic - Vidalia
Vidalia, Georgia, 30474
United States

Collaborators and Investigators

Sponsor: Emory University

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11
Study Completion Date2028-07

Study Record Updates

Study Start Date2024-11
Study Completion Date2028-07

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Alzheimer Disease