BEACoN Study - Biomarker Exploration in Aging, Cognition and Neurodegeneration

BEACoN Study - Biomarker Exploration in Aging, Cognition and Neurodegeneration

Overview

The BEACoN Study (Biomarker Exploration in Aging, Cognition and Neurodegeneration) is a Phase 3 observational study conducted by the University of California, Irvine, investigating the biomarkers of cognitive decline in aging adults["@clinicaltrialsgov"]. The study aims to characterize the relationships between Alzheimer's disease (AD) pathology, brain structure and function, and cognitive performance in cognitively normal older adults["@clinicaltrialsgov"].

BEACoN Study - Biomarker Exploration in Aging, Cognition and Neurodegeneration

Overview

The BEACoN Study (Biomarker Exploration in Aging, Cognition and Neurodegeneration) is a Phase 3 observational study conducted by the University of California, Irvine, investigating the biomarkers of cognitive decline in aging adults["@clinicaltrialsgov"]. The study aims to characterize the relationships between Alzheimer's disease (AD) pathology, brain structure and function, and cognitive performance in cognitively normal older adults["@clinicaltrialsgov"].

Funded by the National Institute on Aging (NIA) through grant R01AG053555, the BEACoN Study is led by Principal Investigator [Michael Yassa](/researchers/michael-yassa), PhD, Professor at UC Irvine["@clinicaltrialsgov"]. The study is actively recruiting participants at UC Irvine in California["@clinicaltrialsgov"].

Study Design

Population and Goals

The BEACoN Study enrolls cognitively intact adults aged 60-85 years from the UCI Alzheimer's Disease Research Center and the local community[@clinicaltrialsgov]. The primary goal is to identify which combination of neuroimaging biomarkers and cognitive tests best predicts longitudinal cognitive decline and progression to [mild cognitive impairment (MCI)](/diseases/mild-cognitive-impairment) or AD[@clinicaltrialsgov].

Key inclusion criteria:

• Age 60-85 years
• Fluent English or Spanish speaking
• Normal cognition: Clinical Dementia Rating (CDR) of 0
• Mini-Mental State Examination (MMSE) score of 25 or higher
• Subjective memory complaints acceptable

• Existing diagnosis of dementia or MCI
• Significant neurological disease (Parkinson's disease, multiple sclerosis, brain tumor)
• Major psychiatric disorders (schizophrenia, bipolar disorder)
• MRI/PET contraindications

Cohort Structure

The study uses a non-randomized, parallel design with 9 cohorts defined by age range and [APOE](/genes/apoe) ε4 carrier status[@clinicaltrialsnav]:

| Cohort | Age Range | APOE Status |
|--------|-----------|-------------|
| Age 60-65 | APOE ε4+ | |
| Age 66-70 | APOE ε4- | |
| Age 66-70 | APOE ε4+ | |
| Age 71-75 | APOE ε4- | |
| Age 71-75 | APOE ε4+ | |
| Age 76-80 | APOE ε4- | |
| Age 76-80 | APOE ε4+ | |
| Age 81+ | APOE ε4- | |
| Age 81+ | APOE ε4+ | |

This design allows researchers to examine how age and genetic risk factors (APOE ε4) interact with biomarkers and cognitive outcomes[@clinicaltrialsgov].

Biomarker Assessments

Amyloid PET Imaging

The study uses florbetapir-F18 (Amyvid™) PET imaging to assess [amyloid-beta](/proteins/amyloid-beta) plaque burden in the brain[@clinicaltrialsgov]. Amyloid imaging is conducted once at baseline to identify participants with elevated amyloid plaques, a key pathological feature of AD[@clinicaltrialsgov].

Tau PET Imaging

The study employs [MK-6240](https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6920812/), a second-generation tau PET tracer, to visualize [tau](/proteins/tau) neurofibrillary tangles in the brain[@clinicaltrialsgov]. Tau PET scans are conducted at baseline and Year 1 to track the progression of tau pathology, which spreads in a characteristic pattern (Braak stages) from the [entorhinal cortex](/cell-types/entorhinal-cortex) to the [hippocampus](/cell-types/hippocampus)[@clinicaltrialsgov].

MRI Imaging

High-resolution MRI protocols include:

• Structural MRI: T1-weighted imaging for volumetric analysis of brain regions
• Functional MRI (fMRI): Resting-state and task-based functional connectivity
• Diffusion MRI: Assessment of white matter integrity and structural connectivity

Cognitive Testing

A comprehensive neuropsychological battery assesses:

• Memory (episodic, working)
• Executive function
• Language
• Visuospatial abilities

Primary and Secondary Outcomes

Primary Outcome

• Change in Clinical Dementia Rating - Sum of Box Scores (CDR-SB) at Years 4 and 5

Secondary Outcomes

Key secondary endpoints include:

Key Findings from Published Research

The BEACoN Study has yielded several important publications:

Pattern Separation and Source Memory

Stevenson et al. (2020) demonstrated that pattern separation and source memory engage distinct hippocampal and neocortical regions during retrieval[@stevenson2020]. This finding has implications for understanding the neural basis of mnemonic discrimination in aging.

Anterolateral Entorhinal Cortex Thickness

Holbrook et al. (2020) identified anterolateral entorhinal cortex thickness as a new biomarker for early detection of AD[@holbrook2020]. This region shows atrophy before the hippocampus in the progression of AD pathology.

Entorhinal-Hippocampal Circuit Integrity

Adams et al. (2022) found that entorhinal-hippocampal circuit integrity is related to mnemonic discrimination and amyloid-beta pathology in older adults[@adams2022a]. The study showed that circuit measures may be more sensitive than individual region volumes.

Hippocampal Subfields

Adams et al. (2023) revealed differential involvement of hippocampal subfields in the relationship between AD pathology and memory interference in older adults[@adams2023].

Scientific Significance

The BEACoN Study makes several important contributions to AD research:

Study Status and Contact Information

• Status: Recruiting
• Enrollment: 300 participants (estimated)
• Start Date: May 1, 2018
• Primary Completion: December 22, 2026 (estimated)
• Study Completion: December 22, 2027 (estimated)

• Email: beacon@uci.edu
• Phone: 949-824-0904

• University of California, Irvine
• Irvine, CA 92697

See Also

• [Alzheimer's Disease](/diseases/alzheimers-disease)
• [Mild Cognitive Impairment](/diseases/mild-cognitive-impairment)
• [APOE](/genes/apoe)
• [Amyloid-beta](/proteins/amyloid-beta)
• [Tau](/proteins/tau)
• [Entorhinal Cortex](/cell-types/entorhinal-cortex)
• [Hippocampus](/cell-types/hippocampus)
• [Clinical Trials Dashboard](/clinical-trials/dashboard)

External Links

• [ClinicalTrials.gov: NCT03860857](https://clinicaltrials.gov/study/NCT03860857)
• [BEACoN Study Website](https://beacon.bio.uci.edu)
• [UC Irvine Alzheimer's Disease Research Center](https://www.alzuci.org/)

References