BEACoN Study - Biomarker Exploration in Aging, Cognition and Neurodegeneration
Overview
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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
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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
Key exclusion criteria:
- 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
The study emphasizes
pattern separation tasks, which are sensitive to early hippocampal dysfunction[@stevenson2020].
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:
Lure Discrimination Index (object, spatial, temporal) - measures pattern separation ability
Entorhinal cortical thickness - structural MRI measure
Perforant path integrity - diffusion MRI measure
Tau spatial distribution - advancing Braak stage on tau PETKey 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:
Preclinical detection: Identifies biomarkers that detect AD pathology before clinical symptoms appear
Multi-modal biomarkers: Combines amyloid PET, tau PET, MRI, and cognitive measures
Pattern separation: Focuses on a cognitive domain particularly sensitive to early AD
Longitudinal design: Tracks changes over time to identify predictors of decline
APOE stratification: Examines how genetic risk modifies biomarker relationships
- Status: Recruiting
- Enrollment: 300 participants (estimated)
- Start Date: May 1, 2018
- Primary Completion: December 22, 2026 (estimated)
- Study Completion: December 22, 2027 (estimated)
Contact:
- Email: beacon@uci.edu
- Phone: 949-824-0904
Location:
- 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
[ClinicalTrials.gov, BEACoN Study - Biomarker Exploration in Aging, Cognition and Neurodegeneration (n.d.)](https://clinicaltrials.gov/study/NCT03860857)
[BEACoN Study Website](https://beacon.bio.uci.edu)
[Stevenson RF et al., Pattern Separation and Source Memory Engage Distinct Hippocampal and Neocortical Regions during Retrieval (2020)](https://doi.org/10.1523/JNEUROSCI.0564-19.2019)
[Holbrook AJ et al., Anterolateral entorhinal cortex thickness as a new biomarker for early detection of Alzheimer's disease (2020)](https://doi.org/10.1002/dad2.12068)
[Adams JN et al., Entorhinal-Hippocampal Circuit Integrity Is Related to Mnemonic Discrimination and Amyloid-beta Pathology in Older Adults (2022)](https://doi.org/10.1523/JNEUROSCI.1165-22.2022)
[Adams JN et al., Differential involvement of hippocampal subfields in the relationship between Alzheimer's pathology and memory interference in older adults (2023)](https://doi.org/10.1002/dad2.12419)