Alzheimer DiseaseNCT05999084
Georgia Memory Net Anti-Amyloid Monoclonal Antibody Registry
An observational study of Alzheimer Disease, run by Emory University at 8 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- Anti-amyloid Monoclonal Antibodies (mAbs)
- Type of treatment
- Injection or infusion
- How many people
- 735 participants
- Where
- 8 sitesUnited States
- Study dates
- 6 Mar 2025to Jul 2028
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study includes patients receiving care through the Emory Cognitive Neurology Clinic and Georgia Memory Net (GMN) clinics, and their caregivers.
Who may be able to join
- 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:
- 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
Show all 10Show fewer
- MRI brain within last year and no exclusionary 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
Who cannot join
- Any contraindication to MRI
- MRI exclusion criteria:
- Acute or sub-acute hemorrhage
- Prior macro hemorrhage (>1 cm), subarachnoid hemorrhage, or known aneurysm
- >4 microhemorrhages
- Superficial siderosis
Show all 19Show fewer
- 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.
- Seizure within the past 6 months or history of refractory epilepsy.
- Unstable severe psychiatric illness in past 6 months
- History of bleeding disorder, blood clotting, or clinically significant abnormal results on coagulation profile (platelet count <50,000; INR >1.5)
- Uncontrolled diabetes (HgbA1c >9%)
- Uncontrolled hypertension
- History of unstable angina, myocardial infarction (MI), advanced heart failure, or clinically significant conduction abnormalities within past year.
- End stage renal disease
- 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)
- Systemic illness or serious infection, e.g., pneumonia, sepsis, Coronavirus disease 2029 (COVID-19), in past 30 days
- Immunological disease requiring immunosuppression, immunoglobulins, monoclonal antibodies, or plasmapheresis
- Exclude if breastfeeding or if female patients of childbearing potential unable to practice highly effective contraception
- History of severe allergic or anaphylactic reactions or hypersensitivity to inactive ingredients (arginine hydrochloride, histidine, histidine hydrochloride monohydrate, polysorbate 80)
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
United States8 sites
Georgia Memory Net Memory Assessment Clinic - Albany
Albany, Georgia, 31707
Georgia Memory Net Memory Assessment Clinic - Atlanta
Atlanta, Georgia, 30303
Emory Cognitive Neurology Clinic at the Emory Brain Health Center
Atlanta, Georgia, 30322
Georgia Memory Net Memory Assessment Clinic - Augusta
Augusta, Georgia, 30912
Georgia Memory Net Memory Assessment Clinic - Gainesville
Gainesville, Georgia, 30501
Georgia Memory Net Memory Assessment Clinic - Macon
Macon, Georgia, 31206
Georgia Memory Net Memory Assessment Clinic - Savannah
Savannah, Georgia, 31406
Georgia Memory Net Memory Assessment Clinic - Vidalia
Vidalia, Georgia, 30474
About this study
Official title: Georgia Memory Net Center for Medicare and Medicaid Services Registry for Anti-Amyloid Monoclonal Antibody Coverage With Evidence Development
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.
Read the detailed description
Alzheimer's disease is a devastating neurodegenerative illness impacting millions of Americans including patients and caregivers. Treatments have been limited to symptomatic therapies leading to the pervasive sentiment that 'nothing can be done'; however, recent advances in the field have created excitement and hope for patients, families, and healthcare providers. On 6 January 2023, the anti-amyloid monoclonal antibody (mAb) lecanemab received accelerated approval from the Food and Drug Administration (FDA). A similar medication, donanemab, also recently demonstrated positive results in a large trial. Despite the positive trials, questions remain about anti-amyloid mAbs efficacy as well as how they will perform in a real-world setting. The Centers for Medicare \& Medicaid Services (CMS) released a National Coverage Analysis (NCA) Memo with a framework for deploying anti-amyloid mAbs in a way that improves understanding of benefit and harm.
This registry will be managed through Georgia Memory Net (GMN), an initiative that was launched in 2018 to build statewide capacity for early and specific diagnosis of Alzheimer's disease and related dementias (ADRD), improve patient and caregiver support, and provide access to emerging disease modifying therapies. The GMN supports Memory Assessment Clinics (MACs) geographically distributed at 7 sites around the state with common data elements modeled on best practices developed in the Emory University Cognitive Neurology Memory Assessment Clinic over the past 25 years. The GMN infrastructure and care model provides an optimal real-world testing ground for evidence development on the effectiveness, safety, and appropriate use of anti-amyloid mAbs in the Medicare population.
The clinical data for patients treated with anti-amyloid mAbs will be compared to historical clinical data from comparable patients who were seen in GMN clinics prior to availability of anti-amyloid mAbs. Patients in the registry will be followed for the duration of their initial treatment as specified by FDA for specific anti-amyloid monoclonal antibody and subsequent maintenance treatment which is currently unspecified.
The objectives of this registry are to:
- Monitor clinical use of FDA approved anti-amyloid mAbs to report health outcomes for patients in broad community practice.
- Understand how patient characteristics, treating clinicians, and clinical settings impact benefits and harms (brain hemorrhage and edema) of FDA approved anti-amyloid mAbs.
- Define how benefits and harms of FDA approved anti-amyloid mAbs change over time.
- Conditions
- Alzheimer Disease
- Being tested
- Anti-amyloid Monoclonal Antibodies (mAbs), Standard of Care
- Keywords
- Monoclonal antibodies, Amyloid, Mild Cognitive Impairment, Lecanemab, Leqembi
- Medical subject headings
- Alzheimer Disease, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-amyloid Monoclonal Antibodies (mAbs)Drug
Also called lecanemab
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 CareCombination product
The standard of care, other than treatment with anti-amyloid mAbs, provided at the study clinics.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Anti-amyloid Monoclonal Antibodies (mAbs) | |
| 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. Receives: Combination Product: Standard of Care | |
| 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. Receives: Drug: Anti-amyloid Monoclonal Antibodies (mAbs) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Quick Dementia Rating System (QDRS) Score
The QDRS is a 10-item questionnaire assessing cognitive impairment. Items are rated on a 5-point scale where no problems = 0, slight problems = 0.5, mild problems = 1, moderate to severe problems = 2, and severe problems = 3. Total scores range from 0 to 30 and higher scores indicate increased cognitive impairment.
Measured: Baseline and every 6 months until end of study (up to 5 years)
Montreal Cognitive Assessment (MoCA) Score
MoCA is an instrument to screen for mild cognitive dysfunction, assessing the cognitive domains of attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation. Total scores range from 0 to 30 with higher scores indicating better cognitive function. A normal score is considered to be 26 or higher.
Measured: Baseline and every 6 months until end of study (up to 5 years)
Change in Functional Activities Questionnaire (FAQ) Score
Instrumental activities of daily living are assessed with the Functional Activities Questionnaire (FAQ). The FAQ includes 10 items which are scored on a scale from 0 to 3 where 0 = normal and 3 = dependent. Total scores range from 0 to 30 and lower scores indicate that the respondent is able to perform daily activities. A score of 9 (where the person is dependent in 3 activities) is used as a cut-point indicating impairments with functioning.
Measured: 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
Independence with tasks such as toilet behaviors, feeding, and grooming is measured with the Physical Self-Maintenance Scale (PSMS). The PSMS is a 6-item instrument with multiple options for responses, which are scored as 0 or 1. Complete independence with the activity is scored as 1 and if any sort of assistance is needed the score is 0 . Total scores range from 0 to 6 with higher scores indicating greater independence with tasks of self-maintenance.
Measured: 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
Functional independence is measured with the Instrumental Activities of Daily Living (IADL) scale. The IADL is an 8-item instrument which assesses how well the respondent can perform daily tasks of using the telephone, shopping, food preparation, housekeeping, laundry, transport, medication, and finances by rating the responses as 0 or 1. The total score for women ranges from 0 to 8 and the total score for men ranges from 0 to 5, with higher scores indicating greater independence.
Measured: Baseline and every 6 months until end of study (up to 5 years)
Secondary outcomes (3)
Change in Care Needs Assessment Tool (CNAT) Score
The CNAT asks caregivers to indicate whether or not certain challenging behaviors (9 items) or difficulties with activities of daily living (4 items) have occurred with the care recipient in the past month. For the behaviors and difficulties that have happened, caregivers rate how much they were bothered by this on a 5-point scale where "not at all" = 0 and "extremely" = 4. Total score for this section range from 0 to 52, with higher scores indicating a increased feelings of being upset about the behaviors and functional difficulties of the care recipient.
Measured: Baseline and every 6 months until end of study (up to 5 years)
Change in Zarit Burden Interview Score
The Zarit Burden Interview instrument assesses caregiver burden and needs. The measurement has 22 items about feelings while caring for another person and each item on the interview is a statement which the caregiver is asked how often they feel that way. Responses are given on a 5-point scale where Never - 0 and Nearly Always = 4. Total scores range from 0 to 88 and higher scores indicate greater feelings of burden.
Measured: Baseline and every 6 months until end of study (up to 5 years)
Change in Patient-Reported Outcomes Measurement Information System Global Health (PROMIS 10) Score
The PROMIS Global Health questionnaire consists of 10 items assessing general domains of health and functioning. Items are scored on a 5-point scale where poor = 1 and excellent = 5. Total scores are standardized to a T-score with a mean of 50 and a standard deviation of 10. Scores above 50 indicate better health and functioning, while scores below 50 indicate physical, mental and social health that is below average.
Measured: Baseline and every 6 months until end of study (up to 5 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start6 Mar 2025
- Primary completionJul 2028 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 735 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Medicare and Medicaid Services
- Responsible party
- Principal investigator, James Lah, Emory University
- Investigators
- James J Lah, MD, PhD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05999084
- Sponsor's protocol ID
- STUDY00006475
- Other IDs
- 2023P006262
- Status last verified
- Jul 2026
- First submitted
- 13 Aug 2023
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data regarding the results of longitudinal cognitive testing and functional surveys, and type, frequency, and severity of adverse events, will be available for sharing with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Georgia Memory Net Center for Medicare and Medicaid Services Registry for Anti-Amyloid Monoclonal Antibody Coverage With Evidence Development
- ClinicalTrials.gov ID
- NCT05999084
- Acronym / sponsor ID
- STUDY00006475
- Conditions
- Alzheimer Disease
- Keywords
- Monoclonal antibodies, Amyloid, Mild Cognitive Impairment, Lecanemab, Leqembi
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 735 participants (estimated)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Centers for Medicare and Medicaid Services
- Study start
- 6 Mar 2025 (actual)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 21 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Alzheimer's disease is a devastating neurodegenerative illness impacting millions of Americans including patients and caregivers. Treatments have been limited to symptomatic therapies leading to the pervasive sentiment that 'nothing can be done'; however, recent advances in the field have created excitement and hope for patients, families, and healthcare providers. On 6 January 2023, the anti-amyloid monoclonal antibody (mAb) lecanemab received accelerated approval from the Food and Drug Administration (FDA). A similar medication, donanemab, also recently demonstrated positive results in a large trial. Despite the positive trials, questions remain about anti-amyloid mAbs efficacy as well as how they will perform in a real-world setting. The Centers for Medicare \& Medicaid Services (CMS) released a National Coverage Analysis (NCA) Memo with a framework for deploying anti-amyloid mAbs in a way that improves understanding of benefit and harm.
This registry will be managed through Georgia Memory Net (GMN), an initiative that was launched in 2018 to build statewide capacity for early and specific diagnosis of Alzheimer's disease and related dementias (ADRD), improve patient and caregiver support, and provide access to emerging disease modifying therapies. The GMN supports Memory Assessment Clinics (MACs) geographically distributed at 7 sites around the state with common data elements modeled on best practices developed in the Emory University Cognitive Neurology Memory Assessment Clinic over the past 25 years. The GMN infrastructure and care model provides an optimal real-world testing ground for evidence development on the effectiveness, safety, and appropriate use of anti-amyloid mAbs in the Medicare population.
The clinical data for patients treated with anti-amyloid mAbs will be compared to historical clinical data from comparable patients who were seen in GMN clinics prior to availability of anti-amyloid mAbs. Patients in the registry will be followed for the duration of their initial treatment as specified by FDA for specific anti-amyloid monoclonal antibody and subsequent maintenance treatment which is currently unspecified.
The objectives of this registry are to:
- Monitor clinical use of FDA approved anti-amyloid mAbs to report health outcomes for patients in broad community practice.
- Understand how patient characteristics, treating clinicians, and clinical settings impact benefits and harms (brain hemorrhage and edema) of FDA approved anti-amyloid mAbs.
- Define how benefits and harms of FDA approved anti-amyloid mAbs change over time.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Anti-amyloid Monoclonal Antibodies (mAbs) | – | Drug: 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. |
| Historical Comparator Group | – | Combination Product: Standard of CareAvailable 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. |
| Caregivers of Patients Receiving Anti-amyloid Monoclonal Antibodies (mAbs) | – | Drug: 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. |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study includes patients receiving care through the Emory Cognitive Neurology Clinic and Georgia Memory Net (GMN) clinics, and their caregivers.
Key inclusion criteria (10 listed)
- 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:
- MRI brain within last year and no exclusionary 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
Key exclusion criteria (19 listed)
- 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
- History of bleeding disorder, blood clotting, or clinically significant abnormal results on coagulation profile (platelet count <50,000; INR >1.5)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anti-amyloid Monoclonal Antibodies (mAbs)Also: lecanemabInfusions 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. | Drug | Anti-amyloid Monoclonal Antibodies (mAbs), Caregivers of Patients Receiving Anti-amyloid Monoclonal Antibodies (mAbs) |
| Standard of CareThe standard of care, other than treatment with anti-amyloid mAbs, provided at the study clinics. | Combination product | Historical Comparator Group |
Primary outcome
Change in Quick Dementia Rating System (QDRS) Score
Time frame: Baseline and every 6 months until end of study (up to 5 years)
The QDRS is a 10-item questionnaire assessing cognitive impairment. Items are rated on a 5-point scale where no problems = 0, slight problems = 0.5, mild problems = 1, moderate to severe problems = 2, and severe problems = 3. Total scores range from 0 to 30 and higher scores indicate increased cognitive impairment.
Montreal Cognitive Assessment (MoCA) Score
Time frame: Baseline and every 6 months until end of study (up to 5 years)
MoCA is an instrument to screen for mild cognitive dysfunction, assessing the cognitive domains of attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation. Total scores range from 0 to 30 with higher scores indicating better cognitive function. A normal score is considered to be 26 or higher.
Change in Functional Activities Questionnaire (FAQ) Score
Time frame: Baseline and every 6 months until end of study (up to 5 years)
Instrumental activities of daily living are assessed with the Functional Activities Questionnaire (FAQ). The FAQ includes 10 items which are scored on a scale from 0 to 3 where 0 = normal and 3 = dependent. Total scores range from 0 to 30 and lower scores indicate that the respondent is able to perform daily activities. A score of 9 (where the person is dependent in 3 activities) is used as a cut-point indicating impairments with functioning.
Change in Lawton-Brody Activities of Daily Living (ADL) Physical Self-Maintenance Scale (PSMS) Score
Time frame: Baseline and every 6 months until end of study (up to 5 years)
Independence with tasks such as toilet behaviors, feeding, and grooming is measured with the Physical Self-Maintenance Scale (PSMS). The PSMS is a 6-item instrument with multiple options for responses, which are scored as 0 or 1. Complete independence with the activity is scored as 1 and if any sort of assistance is needed the score is 0 . Total scores range from 0 to 6 with higher scores indicating greater independence with tasks of self-maintenance.
Change in Lawton-Brody Instrumental Activities of Daily Living (IADL) Scale Score
Time frame: Baseline and every 6 months until end of study (up to 5 years)
Functional independence is measured with the Instrumental Activities of Daily Living (IADL) scale. The IADL is an 8-item instrument which assesses how well the respondent can perform daily tasks of using the telephone, shopping, food preparation, housekeeping, laundry, transport, medication, and finances by rating the responses as 0 or 1. The total score for women ranges from 0 to 8 and the total score for men ranges from 0 to 5, with higher scores indicating greater independence.
3 secondary outcomes
Change in Care Needs Assessment Tool (CNAT) Score
Time frame: Baseline and every 6 months until end of study (up to 5 years)
Change in Zarit Burden Interview Score
Time frame: Baseline and every 6 months until end of study (up to 5 years)
Change in Patient-Reported Outcomes Measurement Information System Global Health (PROMIS 10) Score
Time frame: Baseline and every 6 months until end of study (up to 5 years)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
- Individual participant dataSharing planned: Yes. Individual participant data regarding the results of longitudinal cognitive testing and functional surveys, and type, frequency, and severity of adverse events, will be available for sharing with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
James J Lah, MD, PhD principal investigator
Emory University
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer Disease, run by Emory University at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026.