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Biomarker Exploration in Aging, Cognition and Neurodegeneration

NCT03860857 · University of California, Irvine
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Official title
The BEACoN Study- Biomarker Exploration in Aging, Cognition and Neurodegeneration
About this study
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.
Eligibility criteria
Inclusion Criteria: 1. Aged 60 or older; 2. Speaks fluent English or Spanish; 3. Visual and auditory acuity adequate for neuropsychological and computerized testing; 4. Good general health with no disease(s) expected to interfere with the study; 5. Willing and able to participate for the duration of the study and in all study procedures including MRI and PET; 6. 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. 7. Subjective memory or other cognitive complaints will be included. Exclusion Criteria: 1. Significant co-morbid neurologic disease such as Parkinson's disease, multiple sclerosis, brain cyst, tumor or aneurysm; 2. 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; 3. 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; 4. Existing diagnosis of dementia or mild cognitive impairment; 5. Alcohol or substance abuse or dependence within the past 2 years (DSM-IV criteria); 6. 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; 7. PET contraindications, e.g. significant prior radiation exposure and pregnancy.
Study design
Enrollment target: 300 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2018-05-01
Estimated completion: 2027-12-22
Last updated: 2026-01-23
Interventions
Radiation: Amyloid PET scanDrug: Tau PET scan using MK-6240Behavioral: Neurocognitive testingOther: MRI
Primary outcomes
  • Change in Clinical Dementia Rating - Sum of Box Score (Years 4 and 5 of the grant)
Sponsor
University of California, Irvine · other
With: National Institute on Aging (NIA)
Contacts & investigators
ContactEvelyn Chang, BA · contact · beacon@uci.edu · 949-824-0904
ContactNovelle Meza, BS · contact · njmeza@uci.edu · 949-824-5049
InvestigatorMichael A Yassa, PhD · principal_investigator, University of California, Irvine
InvestigatorLiv C McMillan, BS, CCRP · study_director, University of California, Irvine
All locations (1)
University of California, IrvineRecruiting
Irvine, California, United States
Biomarker Exploration in Aging, Cognition and Neurodegeneration · TrialPath