Georgia Memory Net Anti-Amyloid Monoclonal Antibody Registry

Part of paid clinical trials in Albany, Georgia.

Sponsor
Emory University
Study ID
NCT05999084
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
50 Years - 90 Years
Healthy Volunteers
Not accepted

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.
  • Standard of Care — COMBINATION_PRODUCT
    The standard of care, other than treatment with anti-amyloid mAbs, provided at the study clinics.

Study Details

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.

Key Dates

Start date
Mar 6, 2025
Status verified
Mar 2026
Primary completion
Jul 31, 2028
Completion
Jul 31, 2028

Study Design

Enrollment
735 participants (estimated)

Arms

  • Arm: 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.
  • Arm: 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.
  • Arm: 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.

Primary Outcome Measure

Change in Quick Dementia Rating System (QDRS) Score [ Time Frame: Baseline and every 6 months until end of study (up to 5 years) ]

Central Contacts

Locations (8)

FacilityCityStateZIPSite coordinators
Georgia Memory Net Memory Assessment Clinic - AlbanyAlbanyGeorgia31707-
Emory ClinicAtlantaGeorgia30322-
Georgia Memory Net Memory Assessment Clinic - AtlantaAtlantaGeorgia30303-
Georgia Memory Net Memory Assessment Clinic - AugustaAugustaGeorgia30912-
Georgia Memory Net Memory Assessment Clinic - GainesvilleGainesvilleGeorgia30501-
Georgia Memory Net Memory Assessment Clinic - MaconMaconGeorgia31206-
Georgia Memory Net Memory Assessment Clinic - SavannahSavannahGeorgia31406-
Georgia Memory Net Memory Assessment Clinic - VidaliaVidaliaGeorgia30474-

Find similar trials in Albany, GA

By condition
Alzheimer's disease
By specialty
NeurologyDementia careBrain disordersGeriatrics
By research site
Georgia Memory Net Memory Assessment Clinic - Albany· Albany, GAEmory Clinic· Atlanta, GAGeorgia Memory Net Memory Assessment Clinic - Atlanta· Atlanta, GAGeorgia Memory Net Memory Assessment Clinic - Augusta· Augusta, GAGeorgia Memory Net Memory Assessment Clinic - Gainesville· Gainesville, GAGeorgia Memory Net Memory Assessment Clinic - Macon· Macon, GA

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