By InvitationNot Applicable

Georgia Memory Net Anti-Amyloid Monoclonal Antibody Registry

United States735 participantsStarted 2025-03-06

Plain-language 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.

Who can participate

Age range

50 Years – 90 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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:

Exclusion criteria

. 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
. Any contraindication to MRI
. MRI exclusion criteria:
. Seizure within the past 6 months or history of refractory epilepsy.
. Unstable severe psychiatric illness in past 6 months

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Quick Dementia Rating System (QDRS) Score

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

Montreal Cognitive Assessment (MoCA) Score

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

Change in Functional Activities Questionnaire (FAQ) Score

Timeframe: 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

Timeframe: 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

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

Trial details

NCT IDNCT05999084

SponsorEmory University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2028-07

View on ClinicalTrials.gov More Alzheimer Disease trials

Who can participate

Age range

50 Years – 90 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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:

Exclusion criteria

. 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
. Any contraindication to MRI
. MRI exclusion criteria:
. Seizure within the past 6 months or history of refractory epilepsy.
. Unstable severe psychiatric illness in past 6 months

What they're measuring

Change in Quick Dementia Rating System (QDRS) Score

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

Montreal Cognitive Assessment (MoCA) Score

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

Change in Functional Activities Questionnaire (FAQ) Score

Timeframe: 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

Timeframe: 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

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