Biomarker Exploration in Aging, Cognition and Neurodegeneration (BEACoN)

January 21, 2026 updated by: Michael Yassa, University of California, Irvine

The BEACoN Study- Biomarker Exploration in Aging, Cognition and Neurodegeneration

The purpose of this research study is to understand the factors that underlie changes in thinking and memory with increasing age. The investigators will test the usefulness of MRI, PET, and cognitive testing in detecting subtle changes in the brain that precede cognitive decline. An addendum to this study includes additional PET scans to examine the relationship between tau protein in the brain and cognitive decline. Tau is a protein that is known to form tangles in the areas of the brain important for memory, and these tau tangles are a hallmark of Alzheimer's disease. This sub-study research aims to look at the tau accumulation in the brain using an investigational drug called MK-6240, which is a radio tracer that gets injected prior to a positron emission tomography (PET) scan.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study investigates the relationship between Alzheimer's disease (AD) pathology, brain structure and function, as well as cognition in non-demented older adults. The goal is to develop a more complete understanding of the factors that lead to cognitive decline in the elderly and progression to AD. The investigators will enroll 200 cognitively intact adults between the ages of 60-85 years old from the UCI Alzheimer's Disease Research Center or directly from the local community. Study procedures will include: 1) PET amyloid scans with Amyvid™ radiotracer (florbetapir-F18) and PET tau scans with [18F]MK6240 radiotracer; 2) High-resolution structural, functional, and diffusion MRI; and 3) Cognitive examinations. The investigators will track cognitive outcomes through longitudinal monitoring. Amyloid imaging will only be conducted once in the study at baseline, and MRI and tau PET imaging will be at baseline and Year 1. The investigators aim to identify the best combination of tests for predicting longitudinal cognitive/clinical decline. The proposed study will significantly inform the understanding of cognitive decline in the aging brain and allow investigators to better define preclinical AD and make recommendations for future intervention trials.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
300

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Novelle Meza, BS
  • Phone Number: 949-824-5049
  • Email: njmeza@uci.edu

Study Contact Backup

  • Name: Evelyn Chang, BA
  • Phone Number: 949-824-0904
  • Email: beacon@uci.edu

Study Locations

  • United States
    • California
      • Irvine, California, United States, 92697
        • Recruiting
        • University of California, Irvine
        • Contact:
        • Principal Investigator:
          • Michael A Yassa, PhD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

60 years to 105 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Aged 60 or older;
  2. Speaks fluent English or Spanish;
  3. Visual and auditory acuity adequate for neuropsychological and computerized testing;
  4. Good general health with no disease(s) expected to interfere with the study;
  5. Willing and able to participate for the duration of the study and in all study procedures including MRI and PET;
  6. Normal cognition defined as a Clinical Dementia Rating of 0 and a Mini-Mental State Examination score of 25 or higher. FAST Stage 1 or 2.
  7. Subjective memory or other cognitive complaints will be included.

Exclusion Criteria:

  1. Significant co-morbid neurologic disease such as Parkinson's disease, multiple sclerosis, brain cyst, tumor or aneurysm;
  2. Major health conditions, except for Type II diabetes mellitus, hypercholesterolemia, and hypertension, which are NOT exclusionary for this study given their high prevalence in our target populations;
  3. Significant psychiatric disorders such as schizophrenia, bipolar disorder, or attention-deficit hyperactivity disorder, except for depression and anxiety, which are NOT exclusionary for this study given their high prevalence in our target populations;
  4. Existing diagnosis of dementia or mild cognitive impairment;
  5. Alcohol or substance abuse or dependence within the past 2 years (DSM-IV criteria);
  6. MRI contraindications, e.g. pacemakers, aneurysm clips, artificial heart valves, ear implants, metal fragments or foreign objects in the eyes, skin or body. Females who are pregnant or trying to get pregnant are also excluded;
  7. PET contraindications, e.g. significant prior radiation exposure and pregnancy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Age 60-65 ApoE e4+
Participants in this cohort are between the ages of 60-65 and are ApoE e4 carriers. All participants in this cohort will complete the Amyloid PET scan, Tau PET scan using MK-6240, MRI scans, and neurocognitive testing.
Radiation: Amyloid PET scan
Amyloid Positron Emission Tomography scan using radio tracer florbetapir-F18
Drug: Tau PET scan using MK-6240
Tau Positron Emission Tomography scan using radio tracer MK-6240
Other Names:
  • tau PET
Behavioral: Neurocognitive testing
A battery of clinical neuropsychological assessments and computerized cognitive tasks will be used to test participants' memory and cognitive abilities.
Other: MRI
High-resolution structural, functional, and diffusion Magnetic Resonance Imaging scans will be collected during the study.
Experimental: Age 66-70 ApoE e4-
Participants in this cohort are between the ages of 66-70 and are not ApoE e4 carriers. All participants in this cohort will complete the Amyloid PET scan, Tau PET scan using MK-6240, MRI scans, and neurocognitive testing.
Radiation: Amyloid PET scan
Amyloid Positron Emission Tomography scan using radio tracer florbetapir-F18
Drug: Tau PET scan using MK-6240
Tau Positron Emission Tomography scan using radio tracer MK-6240
Other Names:
  • tau PET
Behavioral: Neurocognitive testing
A battery of clinical neuropsychological assessments and computerized cognitive tasks will be used to test participants' memory and cognitive abilities.
Other: MRI
High-resolution structural, functional, and diffusion Magnetic Resonance Imaging scans will be collected during the study.
Experimental: Age 66-70 ApoE e4+
Participants in this cohort are between the ages of 66-70 and are ApoE e4 carriers. All participants in this cohort will complete the Amyloid PET scan, Tau PET scan using MK-6240, MRI scans, and neurocognitive testing.
Radiation: Amyloid PET scan
Amyloid Positron Emission Tomography scan using radio tracer florbetapir-F18
Drug: Tau PET scan using MK-6240
Tau Positron Emission Tomography scan using radio tracer MK-6240
Other Names:
  • tau PET
Behavioral: Neurocognitive testing
A battery of clinical neuropsychological assessments and computerized cognitive tasks will be used to test participants' memory and cognitive abilities.
Other: MRI
High-resolution structural, functional, and diffusion Magnetic Resonance Imaging scans will be collected during the study.
Experimental: Age 71-75 ApoE e4-
Participants in this cohort are between the ages of 71-75 and are not ApoE e4 carriers. All participants in this cohort will complete the Amyloid PET scan, Tau PET scan using MK-6240, MRI scans, and neurocognitive testing.
Radiation: Amyloid PET scan
Amyloid Positron Emission Tomography scan using radio tracer florbetapir-F18
Drug: Tau PET scan using MK-6240
Tau Positron Emission Tomography scan using radio tracer MK-6240
Other Names:
  • tau PET
Behavioral: Neurocognitive testing
A battery of clinical neuropsychological assessments and computerized cognitive tasks will be used to test participants' memory and cognitive abilities.
Other: MRI
High-resolution structural, functional, and diffusion Magnetic Resonance Imaging scans will be collected during the study.
Experimental: Age 71-75 ApoE e4+
Participants in this cohort are between the ages of 71-75 and are ApoE e4 carriers. All participants in this cohort will complete the Amyloid PET scan, Tau PET scan using MK-6240, MRI scans, and neurocognitive testing.
Radiation: Amyloid PET scan
Amyloid Positron Emission Tomography scan using radio tracer florbetapir-F18
Drug: Tau PET scan using MK-6240
Tau Positron Emission Tomography scan using radio tracer MK-6240
Other Names:
  • tau PET
Behavioral: Neurocognitive testing
A battery of clinical neuropsychological assessments and computerized cognitive tasks will be used to test participants' memory and cognitive abilities.
Other: MRI
High-resolution structural, functional, and diffusion Magnetic Resonance Imaging scans will be collected during the study.
Experimental: Age 76-80 ApoE e4-
Participants in this cohort are between the ages of 76-80 and are not ApoE e4 carriers. All participants in this cohort will complete the Amyloid PET scan, Tau PET scan using MK-6240, MRI scans, and neurocognitive testing.
Radiation: Amyloid PET scan
Amyloid Positron Emission Tomography scan using radio tracer florbetapir-F18
Drug: Tau PET scan using MK-6240
Tau Positron Emission Tomography scan using radio tracer MK-6240
Other Names:
  • tau PET
Behavioral: Neurocognitive testing
A battery of clinical neuropsychological assessments and computerized cognitive tasks will be used to test participants' memory and cognitive abilities.
Other: MRI
High-resolution structural, functional, and diffusion Magnetic Resonance Imaging scans will be collected during the study.
Experimental: Age 76-80 ApoE e4+
Participants in this cohort are between the ages of 76-80 and are ApoE e4 carriers. All participants in this cohort will complete the Amyloid PET scan, Tau PET scan using MK-6240, MRI scans, and neurocognitive testing.
Radiation: Amyloid PET scan
Amyloid Positron Emission Tomography scan using radio tracer florbetapir-F18
Drug: Tau PET scan using MK-6240
Tau Positron Emission Tomography scan using radio tracer MK-6240
Other Names:
  • tau PET
Behavioral: Neurocognitive testing
A battery of clinical neuropsychological assessments and computerized cognitive tasks will be used to test participants' memory and cognitive abilities.
Other: MRI
High-resolution structural, functional, and diffusion Magnetic Resonance Imaging scans will be collected during the study.
Experimental: Age 81+ ApoE e4-
Participants in this cohort are between the ages of 81-85 and are not ApoE e4 carriers. All participants in this cohort will complete the Amyloid PET scan, Tau PET scan using MK-6240, MRI scans, and neurocognitive testing.
Radiation: Amyloid PET scan
Amyloid Positron Emission Tomography scan using radio tracer florbetapir-F18
Drug: Tau PET scan using MK-6240
Tau Positron Emission Tomography scan using radio tracer MK-6240
Other Names:
  • tau PET
Behavioral: Neurocognitive testing
A battery of clinical neuropsychological assessments and computerized cognitive tasks will be used to test participants' memory and cognitive abilities.
Other: MRI
High-resolution structural, functional, and diffusion Magnetic Resonance Imaging scans will be collected during the study.
Experimental: Age 81+ ApoE e4+
Participants in this cohort are between the ages of 81-85 and are ApoE e4 carriers. All participants in this cohort will complete the Amyloid PET scan, Tau PET scan using MK-6240, MRI scans, and neurocognitive testing.
Radiation: Amyloid PET scan
Amyloid Positron Emission Tomography scan using radio tracer florbetapir-F18
Drug: Tau PET scan using MK-6240
Tau Positron Emission Tomography scan using radio tracer MK-6240
Other Names:
  • tau PET
Behavioral: Neurocognitive testing
A battery of clinical neuropsychological assessments and computerized cognitive tasks will be used to test participants' memory and cognitive abilities.
Other: MRI
High-resolution structural, functional, and diffusion Magnetic Resonance Imaging scans will be collected during the study.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Clinical Dementia Rating - Sum of Box Score
Time Frame: Years 4 and 5 of the grant
A measure of cognitive/clinical decline
Years 4 and 5 of the grant

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in lure discrimination index - objects
Time Frame: Years 4 and 5 of the grant
Key measure of performance on the object pattern separation task
Years 4 and 5 of the grant
Change in lure discrimination index - spatial
Time Frame: Years 4 and 5 of the grant
Key measure of performance on the spatial pattern separation task
Years 4 and 5 of the grant
Change in lure discrimination index - temporal
Time Frame: Years 4 and 5 of the grant
Key measure of performance on the temporal pattern separation task
Years 4 and 5 of the grant
Change in entorhinal cortical thickness
Time Frame: Years 4 and 5 of the grant
Key measure of structural decline on MRI scans
Years 4 and 5 of the grant
Change in perforant path integrity
Time Frame: Years 4 and 5 of the grant
Key measure of structural connectivity decline on MRI scans
Years 4 and 5 of the grant
Change in tau spatial distribution - advancing Braak stage
Time Frame: Years 4 and 5 of the grant
Key measure of tau spatial spread on tau PET scans
Years 4 and 5 of the grant

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of California, Irvine

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Aging (NIA)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Michael A Yassa, PhD, University of California, Irvine
  • Study Director: Liv C McMillan, BS, CCRP, University of California, Irvine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2018

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 22, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 22, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 15, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 28, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 4, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 23, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 21, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20173832
  • R01AG053555 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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