ClinicalTrials.gg
Active, not recruitingNCT06043700Updated Oct 27, 2026

A Community-Based Screening Program to Identify Participants at High Risk for Amyloid Pathology

An observational study in Alzheimer's Disease, sponsored by Eisai Limited. Active, not recruiting at 3 sites in United States. Open to participants aged 50 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-27.

Sponsored by Eisai Limited · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
2,000
Ages
50 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Alzheimer's Disease

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Keywords

  • Alzheimers Disease
  • Blood-based biomarkers
  • Community-based screening
03

In context

Alzheimer Disease

3,965 studies on the registry are indexed under Alzheimer Disease; 926 are open to participants now.

This study's planned enrollment of 2,000 is above the median of 200 across 814 observational studies indexed under Alzheimer Disease.

Browse Alzheimer Disease studies →

Lead sponsor

Eisai Limited is the lead sponsor of 48 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Participants with or without symptoms of AD will be screened in this study.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Male or female, age 50 to 80 years inclusive, at the time of

    - 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
  2. Provide written informed consent
  3. Willing and able to comply with all aspects of the protocol
  4. Willing to be referred to a clinical site if the assessment results meet the criteria

Exclusion criteria

Exclusion Criteria:

  1. Known uncontrolled medical conditions (example, cardiac, respiratory, gastrointestinal, psychiatric, renal disease, malignant neoplasm)
  2. Participation in an interventional clinical trial study at the time of consent
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
2,000 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • All Participants

    Participants with or without symptoms of AD will be enrolled and observed in this study.

    Other: No Intervention

Interventions

  • OtherNo Intervention

    No treatment intervention will be administered.

06

What researchers measure

Primary outcomes

  1. Number of Participants With Low, Medium, and High Amyloid Pathology

    Number of participants with low, medium, and high amyloid pathology will be estimated.

    Time frame: At Screening on Day 1

07

Study locations

3 sites
  • Eisai Site #3
    Clermont, Florida 34711, United States
  • Eisai Site #1
    Lady Lake, Florida 32159, United States
  • Eisai Site #2
    District Heights, Maryland 20747, United States
08

References and documents

Individual participant data

Plan to share: Yes — Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Sep 2023 (actual). Primary completion is estimated for Mar 2028, 54 months after the start.

Of 41 industry-sponsored observational studies under Alzheimer Disease, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 63. This study's planned 54 months is above that.

Counting every sponsor, half of 405 studies reached it within 67 months; a quarter within 35 and three quarters within 171.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 12, 2023
First posted
Sep 21, 2023
StartActual
Sep 12, 2023
Primary completionEst.
Mar 31, 2028
CompletionEst.
Mar 31, 2028
Last update
Oct 27, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Minor edits
Nothing that changes what the study is or who can join. Edited: verification date
1 update, last Oct 27, 2026
Show all 1 update
  1. Oct 27, 2026
    Minor edits only
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06043700
Lead sponsor
Eisai Limited
Responsible party
Sponsor
First posted
Sep 21, 2023
Start date
Sep 12, 2023
Primary completion
Mar 31, 2028 (estimated)
Completion
Mar 31, 2028 (estimated)
Last update
Oct 27, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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