RecruitingPhase 3NCT03860857

Biomarker Exploration in Aging, Cognition and Neurodegeneration

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


Sponsor

University of California, Irvine

Enrollment

300 participants

Start Date

May 1, 2018

Study Type

INTERVENTIONAL

Conditions

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. 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.


Eligibility

Min Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This study is tracking older adults over time using brain scans (MRI and PET), blood tests, and memory assessments to identify early biological markers of Alzheimer's disease and other causes of age-related cognitive decline, with a focus on diverse populations including Spanish speakers. **You may be eligible if...** - You are 60 years old or older - You speak English or Spanish fluently - You have normal cognition (not diagnosed with dementia), with or without subjective memory concerns - You are in generally good health and able to complete all study visits including brain MRI and PET scans - Your vision and hearing are adequate for cognitive testing **You may NOT be eligible if...** - You have a significant neurological disease such as Parkinson's disease, multiple sclerosis, brain tumors, or a history of serious brain injury - You have a serious psychiatric condition such as schizophrenia or bipolar disorder (note: depression and anxiety are NOT exclusionary) - You have been diagnosed with dementia - You have major health conditions that would interfere with the study - You have contraindications to MRI or PET scanning Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONAmyloid PET scan

Amyloid Positron Emission Tomography scan using radio tracer florbetapir-F18

DRUGTau PET scan using MK-6240

Tau Positron Emission Tomography scan using radio tracer MK-6240

BEHAVIORALNeurocognitive testing

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

OTHERMRI

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


Locations(1)

University of California, Irvine

Irvine, California, United States

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NCT03860857


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