AzTrials
AzTrials

Alzheimer DiseasePhase 3BEACoNNCT03860857

Biomarker Exploration in Aging, Cognition and Neurodegeneration

A Phase 3 study testing Amyloid PET scan, Tau PET scan using MK-6240 and Neurocognitive testing in people with Alzheimer Disease and Cognitive Impairment, run by University of California, Irvine at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 60 years and olderHealthy volunteers can take part
What is being tested?
Amyloid PET scan, Tau PET scan using MK-6240 and Neurocognitive testing
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
1 siteUnited States
Study dates
1 May 2018to 22 Dec 2027
Phase
Phase 3
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 60 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Aged 60 or older;
  • Speaks fluent English or Spanish;
  • Visual and auditory acuity adequate for neuropsychological and computerized testing;
  • Good general health with no disease(s) expected to interfere with the study;
  • Willing and able to participate for the duration of the study and in all study procedures including MRI and PET;
  • 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.
  • Subjective memory or other cognitive complaints will be included.

Who cannot join

  • Significant co-morbid neurologic disease such as Parkinson's disease, multiple sclerosis, brain cyst, tumor or aneurysm;
  • 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;
  • 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;
  • Existing diagnosis of dementia or mild cognitive impairment;
  • Alcohol or substance abuse or dependence within the past 2 years (DSM-IV criteria);
  • 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;
  • PET contraindications, e.g. significant prior radiation exposure and pregnancy.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Evelyn Chang, BA contact

949-824-0904

beacon@uci.edu

Novelle Meza, BS contact

949-824-5049

njmeza@uci.edu

United States1 site, 1 recruiting

  • University of California, Irvine

    Irvine, California, 92697

    Evelyn Chang, BA, 949-824-0904, beacon@uci.edu

    Novelle Meza, BS, 949-824-5049, njmeza@uci.edu

    Recruiting

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Amyloid PET scan, Tau PET scan using MK-6240, Neurocognitive testing, MRI
Keywords
Alzheimer disease, cognitive impairment, mild cognitive impairment, biomarker, MRI, PET
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.

  • Amyloid PET scanRadiation

    Amyloid Positron Emission Tomography scan using radio tracer florbetapir-F18

  • Tau PET scan using MK-6240Drug

    Also called tau PET

    Tau Positron Emission Tomography scan using radio tracer MK-6240

  • Neurocognitive testingBehavioural

    A battery of clinical neuropsychological assessments and computerized cognitive tasks will be used to test participants' memory and cognitive abilities.

  • MRIOther

    High-resolution structural, functional, and diffusion Magnetic Resonance Imaging scans will be collected during the study.

Study groups in NCT03860857
Study groupRoleWhat they receive
Age 60-65 ApoE e4+ExperimentalParticipants 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.
Receives: Radiation: Amyloid PET scan; Drug: Tau PET scan using MK-6240; Behavioral: Neurocognitive testing; Other: MRI
Age 66-70 ApoE e4-ExperimentalParticipants 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.
Receives: Radiation: Amyloid PET scan; Drug: Tau PET scan using MK-6240; Behavioral: Neurocognitive testing; Other: MRI
Age 66-70 ApoE e4+ExperimentalParticipants 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.
Receives: Radiation: Amyloid PET scan; Drug: Tau PET scan using MK-6240; Behavioral: Neurocognitive testing; Other: MRI
Age 71-75 ApoE e4-ExperimentalParticipants 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.
Receives: Radiation: Amyloid PET scan; Drug: Tau PET scan using MK-6240; Behavioral: Neurocognitive testing; Other: MRI
Age 71-75 ApoE e4+ExperimentalParticipants 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.
Receives: Radiation: Amyloid PET scan; Drug: Tau PET scan using MK-6240; Behavioral: Neurocognitive testing; Other: MRI
Age 76-80 ApoE e4-ExperimentalParticipants 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.
Receives: Radiation: Amyloid PET scan; Drug: Tau PET scan using MK-6240; Behavioral: Neurocognitive testing; Other: MRI
Age 76-80 ApoE e4+ExperimentalParticipants 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.
Receives: Radiation: Amyloid PET scan; Drug: Tau PET scan using MK-6240; Behavioral: Neurocognitive testing; Other: MRI
Age 81+ ApoE e4-ExperimentalParticipants 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.
Receives: Radiation: Amyloid PET scan; Drug: Tau PET scan using MK-6240; Behavioral: Neurocognitive testing; Other: MRI
Age 81+ ApoE e4+ExperimentalParticipants 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.
Receives: Radiation: Amyloid PET scan; Drug: Tau PET scan using MK-6240; Behavioral: Neurocognitive testing; Other: MRI

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Clinical Dementia Rating - Sum of Box Score

    A measure of cognitive/clinical decline

    Measured: Years 4 and 5 of the grant

Secondary outcomes (6)

  1. Change in lure discrimination index - objects

    Key measure of performance on the object pattern separation task

    Measured: Years 4 and 5 of the grant

  2. Change in lure discrimination index - spatial

    Key measure of performance on the spatial pattern separation task

    Measured: Years 4 and 5 of the grant

  3. Change in lure discrimination index - temporal

    Key measure of performance on the temporal pattern separation task

    Measured: Years 4 and 5 of the grant

  4. Change in entorhinal cortical thickness

    Key measure of structural decline on MRI scans

    Measured: Years 4 and 5 of the grant

  5. Change in perforant path integrity

    Key measure of structural connectivity decline on MRI scans

    Measured: Years 4 and 5 of the grant

  6. Change in tau spatial distribution - advancing Braak stage

    Key measure of tau spatial spread on tau PET scans

    Measured: Years 4 and 5 of the grant

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Mar 2019
  2. Study start1 May 2018
  3. Primary completion22 Dec 2026 (estimated)
  4. Study completion22 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Health services research
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
All participants will complete the same study procedures, including the tau PET scans with investigational radio tracer 18F-MK6240. The arms define the age range and APOE status of the participants, with each having their own enrollment target.
Masking
None (open label)
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03860857
Sponsor's protocol ID
20173832
Other IDs
R01AG053555
Acronym
BEACoN
Status last verified
Jan 2026
First submitted
15 Feb 2019
Last updated
23 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Stevenson RF, Reagh ZM, Chun AP, Murray EA, Yassa MA. Pattern Separation and Source Memory Engage Distinct Hippocampal and Neocortical Regions during Retrieval. J Neurosci. 2020 Jan 22;40(4):843-851. doi: 10.1523/JNEUROSCI.0564-19.2019. Epub 2019 Nov 20.

    PubMed 31748377

  • Holbrook AJ, Tustison NJ, Marquez F, Roberts J, Yassa MA, Gillen DL; Alzheimer's Disease Neuroimaging Initiative section sign. Anterolateral entorhinal cortex thickness as a new biomarker for early detection of Alzheimer's disease. Alzheimers Dement (Amst). 2020 Aug 25;12(1):e12068. doi: 10.1002/dad2.12068. eCollection 2020.

    PubMed 32875052

  • Chappel-Farley MG, Mander BA, Neikrug AB, Stehli A, Nan B, Grill JD, Yassa MA, Benca RM. Symptoms of obstructive sleep apnea are associated with less frequent exercise and worse subjective cognitive function across adulthood. Sleep. 2022 Mar 14;45(3):zsab240. doi: 10.1093/sleep/zsab240.

    PubMed 34604910

  • Adams JN, Kim S, Rizvi B, Sathishkumar M, Taylor L, Harris AL, Mikhail A, Keator DB, McMillan L, Yassa MA. Entorhinal-Hippocampal Circuit Integrity Is Related to Mnemonic Discrimination and Amyloid-beta Pathology in Older Adults. J Neurosci. 2022 Nov 16;42(46):8742-8753. doi: 10.1523/JNEUROSCI.1165-22.2022. Epub 2022 Oct 27.

    PubMed 36302636

  • Adams JN, Marquez F, Larson MS, Janecek JT, Miranda BA, Noche JA, Taylor L, Hollearn MK, McMillan L, Keator DB, Head E, Rissman RA, Yassa MA. Differential involvement of hippocampal subfields in the relationship between Alzheimer's pathology and memory interference in older adults. Alzheimers Dement (Amst). 2023 Apr 5;15(2):e12419. doi: 10.1002/dad2.12419. eCollection 2023 Apr-Jun.

    PubMed 37035460

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Amyloid PET scan, Tau PET scan using MK-6240 and Neurocognitive testing in people with Alzheimer Disease and Cognitive Impairment, run by University of California, Irvine at 1 site 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 7 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Contact Evelyn Chang, BA (949-824-0904, beacon@uci.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Clinical Dementia Rating - Sum of Box Score (time frame: Years 4 and 5 of the grant). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03860857, which also lists 5 linked publications.

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 23 Jan 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in