Alzheimer's DiseaseNCT06043700
A Community-Based Screening Program to Identify Participants at High Risk for Amyloid Pathology
An observational study of Alzheimer's Disease, run by Eisai Limited at 3 sites in United States.
Trial summary
The primary purpose of this study is to identify participants with or without symptoms of Alzheimer's Disease (AD) that are at high risk for brain amyloid pathology using blood-based biomarkers. Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer's Disease
- How many people
- 2,000 participants
- Where
- 3 sitesUnited States
- Study dates
- 12 Sep 2023to 31 Mar 2028
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants with or without symptoms of AD will be screened in this study.
Who may be able to join
- Male or female, age 50 to 80 years inclusive, at the time of informed consent
- Those 50 to 64 years of age must have 1 of the following risk factors confirmed prior to blood sample collection:
- First degree relative with dementia onset before age 75,
- Known before screening to have at least 1 Apolipoprotein E4 (APOE4) allele, or
- Known before screening to have elevated brain amyloid according to previous positron emission tomography (PET), cerebrospinal fluid (CSF), or blood testing
- Provide written informed consent
- Willing and able to comply with all aspects of the protocol
- Willing to be referred to a clinical site if the assessment results meet the criteria
Who cannot join
- Known uncontrolled medical conditions (example, cardiac, respiratory, gastrointestinal, psychiatric, renal disease, malignant neoplasm)
- Participation in an interventional clinical trial study at the time of consent
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Eisai Site #3
Clermont, Florida, 34711
Eisai Site #2
District Heights, Maryland, 20747
Eisai Site #1
Lady Lake, Florida, 32159
About this study
Official title: A Community-Based Screening Program to Identify, Using Blood-Based Biomarkers, Individuals With or Without Alzheimer's Disease Symptoms Who Are at High Risk for Brain Amyloid Pathology
The primary purpose of this study is to identify participants with or without symptoms of Alzheimer's Disease (AD) that are at high risk for brain amyloid pathology using blood-based biomarkers.
- Conditions
- Alzheimer's Disease
- Being tested
- No Intervention
- Keywords
- Alzheimers Disease, Blood-based biomarkers, Community-based screening
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionOther
No treatment intervention will be administered.
| Study group | Role | What they receive |
|---|---|---|
| All Participants | Participants with or without symptoms of AD will be enrolled and observed in this study. Receives: Other: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Low, Medium, and High Amyloid Pathology
Number of participants with low, medium, and high amyloid pathology will be estimated.
Measured: At Screening on Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start12 Sep 2023
- Primary completion31 Mar 2028 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eisai Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06043700
- Sponsor's protocol ID
- R2000-G000-008
- Status last verified
- Oct 2026
- First submitted
- 12 Sep 2023
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Community-Based Screening Program to Identify, Using Blood-Based Biomarkers, Individuals With or Without Alzheimer's Disease Symptoms Who Are at High Risk for Brain Amyloid Pathology
- ClinicalTrials.gov ID
- NCT06043700
- Acronym / sponsor ID
- R2000-G000-008
- Conditions
- Alzheimer's Disease
- Keywords
- Alzheimers Disease, Blood-based biomarkers, Community-based screening
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Eisai LimitedIndustry (pharma, biotech, devices)
- Study start
- 12 Sep 2023 (actual)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 21 Sep 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 primary purpose of this study is to identify participants with or without symptoms of Alzheimer's Disease (AD) that are at high risk for brain amyloid pathology using blood-based biomarkers.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Participants | – | Other: No InterventionParticipants with or without symptoms of AD will be enrolled and observed in this study. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with or without symptoms of AD will be screened in this study.
Key inclusion criteria (8 listed)
- Male or female, age 50 to 80 years inclusive, at the time of informed consent
- Provide written informed consent
- Willing and able to comply with all aspects of the protocol
- Willing to be referred to a clinical site if the assessment results meet the criteria
Key exclusion criteria (2 listed)
- Known uncontrolled medical conditions (example, cardiac, respiratory, gastrointestinal, psychiatric, renal disease, malignant neoplasm)
- Participation in an interventional clinical trial study at the time of consent
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 |
|---|---|---|
| No InterventionNo treatment intervention will be administered. | Other | All Participants |
Primary outcome
Number of Participants With Low, Medium, and High Amyloid Pathology
Time frame: At Screening on Day 1
Number of participants with low, medium, and high amyloid pathology will be estimated.
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 27 Oct 2026.
- Individual participant dataSharing planned: Yes. Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 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's Disease, run by Eisai Limited at 3 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 8 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Number of Participants With Low, Medium, and High Amyloid Pathology (time frame: At Screening on Day 1). 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 27 Oct 2026.