University of California, Irvine
Irvine, California, 92697, United States
Location status: Recruiting
Location contact
Evelyn Chang, BA
CONTACT
Michael A Yassa, PhD
PRINCIPAL_INVESTIGATOR
Novelle Meza, BS
CONTACT
NCT Number: NCT03860857
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.
Interested in participating?
Request Info60 year and older
All sexes
Interventional
Phase 3
Irvine, California, 92697, United States
Location status: Recruiting
Evelyn Chang, BA
CONTACT
Michael A Yassa, PhD
PRINCIPAL_INVESTIGATOR
Novelle Meza, BS
CONTACT
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Amyloid Positron Emission Tomography scan using radio tracer florbetapir-F18
Tau Positron Emission Tomography scan using radio tracer MK-6240
Other names: tau PET
A battery of clinical neuropsychological assessments and computerized cognitive tasks will be used to test participants' memory and cognitive abilities.
High-resolution structural, functional, and diffusion Magnetic Resonance Imaging scans will be collected during the study.
Time frame: Years 4 and 5 of the grant
A measure of cognitive/clinical decline
Time frame: Years 4 and 5 of the grant
Key measure of performance on the object pattern separation task
Time frame: Years 4 and 5 of the grant
Key measure of performance on the spatial pattern separation task
Time frame: Years 4 and 5 of the grant
Key measure of performance on the temporal pattern separation task
Time frame: Years 4 and 5 of the grant
Key measure of structural decline on MRI scans
Time frame: Years 4 and 5 of the grant
Key measure of structural connectivity decline on MRI scans
Time frame: Years 4 and 5 of the grant
Key measure of tau spatial spread on tau PET scans
Contact information is provided by the study sponsor or research team.
Evelyn Chang, BA
CONTACT
Novelle Meza, BS
CONTACT
University of California, Irvine
Other
The BEACoN Study- Biomarker Exploration in Aging, Cognition and Neurodegeneration
Acronym: BEACoN
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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