CClinicalTrials.gg
Enrolling by invitationNCT04994847Updated Jul 20, 2025

APOE in the Predisposition to, Protection From, and Prevention of Alzheimer's Disease

An observational study in Alzheimer Disease, sponsored by Banner Health. Enrolling by invitation at 1 site in United States. Open to participants aged 50 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-07-20.

Sponsored by Banner Health · Observational

From the registry’s dates

  • Primary completion was expected by Jun 2026, 3 months ago, but the record still lists the study as enrolling by invitation.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
300
Ages
50 Years to 90 Years
Sex
All
01

Study summary

The purpose of this study is to track changes in the brain related to Alzheimer's disease. The results from this study will be used to develop new approaches to prevent or delay the onset of memory and thinking problems associated with Alzheimer's.

Read the detailed description

This study aims to establish, use, and extensively share a comprehensive longitudinal resource of genetic, non-genetic, and cognitive data, brain imaging and fluid biomarker measurements of amyloid-β, tau pathophysiology, neurodegeneration, and inflammation and biological samples to advance the study of cognitively unimpaired older adults at six levels of genetic risk for Alzheimer's disease due to their APOE genotype including understudied APOE2 and APOE4 homozygotes (HMs) at the lowest and highest risk and those APOE4 HMs and heterozygotes (HTs) who remain unimpaired at older ages due to unknown protective factors and spared pathophysiological effects despite their genetic risk.

Each participant will provide blood samples for clinical lab analysis, DNA, RNA, plasma, serum, and peripheral blood mononuclear cells (PBMCs) every 12 months; amyloid and tau PET scans, a nearly one hour battery of MRIs, a lumbar puncture (LP) for the collection of CSF samples, and a comprehensive battery of cognitive, behavioral, risk factor, and other assessments every 24 months. Extracted DNA will be used to characterize the participant's APOE genotype, screen for rare APOE variants that might make them eligible for other studies, and perform whole genome sequencing (WGS) and genome-wide genotyping.

02

Conditions studied

  • Alzheimer Disease

Browse trials for

03

In context

Alzheimer Disease

3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.

This study's planned enrollment of 300 is above the median of 200 across 751 observational studies indexed under Alzheimer Disease.

Browse Alzheimer Disease studies →

Lead sponsor

Banner Health is the lead sponsor of 18 studies on the registry; 8 are open to participants now.

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

04

Who can participate

Ages eligible
50 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

For the Arizona APOE Cohort, we will establish a new longitudinal cohort of 300 cognitively unimpaired males and non-pregnant females, 50-90 years of age at the time of enrollment who will be enrolled based on their APOE genotype, age, other eligibility criteria, consent to participate in virtually all study procedures, and consent to provide a shared resource of anonymized data and biological samples for the research community. Participants will include 50 individuals with each of the six common APOE genotypes (known as 2/2, 2/3, 3/3, 2/4, 3/4, and 4/4) who are matched by age decile, sex, and educational level. Participants will not receive information about their APOE genotype from this project97 and will be studied under the auspicious of a single Institutional Review Board (IRB).

Inclusion criteria

  • Male or female age 50 to 90 years old in good general health with no diseases expected to interfere with the study.
  • Willing to undergo health and cognitive assessments, brain imaging sessions (MRI and PET), and collection and banking of blood with venipuncture and CSF by lumbar puncture for genetic research, biomarker research, and DNA banking.
  • Determined to be cognitively unimpaired by PI (mechanisms may include verbal interview, participant or study partner reports or specific scores on cognitive assessments)

Exclusion criteria

Exclusion Criteria:

  • Participants with significant health issues or medical diseases that may interfere with participation, including infectious diseases that pose a risk to study personnel.
  • For PET or MRI: Female participant who is pregnant, lactating, or of childbearing potential without a negative pregnancy test or being two years postmenopausal or surgically sterile.
  • For MRI: Any contraindication for MRI including, but not limited to, pacemaker, aneurysm clips, artificial heart valves, ear implants, metal fragments or foreign objects in the eyes, skin, or body.
  • For CSF collection: Medical or surgical contraindication for lumbar puncture (e.g. on anti-coagulant therapy or had prior lumbar spinal surgery).
05

Study design

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

Groups and cohorts

  • APOE Unimpaired Observational Trial

    300 participants who are cognitively unimpaired; Yearly procedures: blood draw Every Two Year Procedures: cognitive and clinical assessments, CSF collection, MRI, and Tau and Amyloid PET scans

    Drug: Amyloid and Tau PET

Interventions

  • DrugAmyloid and Tau PET

    NAV4694 and MK6240 PET scans completed every two years

06

What researchers measure

Primary outcomes

  1. Amyloid PET Scan

    The study will acquire NAV4694, a radiotracer specific to amyloid, PET scans to monitor total amyloid levels in the brain.

    Time frame: 5 years

  2. Tau PET Scan

    The study will acquire MK6240, a radiotracer specific to Tau, PET scans to monitor total tau levels in the brain.

    Time frame: 5 years

  3. MRI

    The study will acquire 3T MRI to look at brain volume

    Time frame: 5 years

07

Study locations

1 site
  • Banner Alzheimer's Institute
    Phoenix, Arizona 85006, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 20, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04994847
Lead sponsor
Banner Health
Collaborators
Mayo Clinic
Responsible party
Sponsor
First posted
Aug 6, 2021
Start date
May 1, 2021
Primary completion
Jun 30, 2026 (estimated)
Completion
Jun 30, 2026 (estimated)
Last update
Jul 20, 2025

Oversight

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

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

No contact was published for this record. The registry link below has the sponsor’s details.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion