Biomarker Exploration in Aging, Cognition and Neurodegeneration

a study on Alzheimer's Disease Cognitive Impairment Cognitive Decline

Summary

Eligibility
for people ages 60 years and up (full criteria)
Healthy Volunteers
healthy people welcome
Location
at Irvine, California
Dates
study started
completion around
Principal Investigator
by Michael A Yassa, PhD

Description

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.

Official Title

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

Details

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.

Keywords

Alzheimer Disease, Cognitive Impairment, Cognitive Decline, mild cognitive impairment, biomarker, MRI, PET, Nerve Degeneration, Cognitive Dysfunction, Amyloid PET scan, Tau PET scan using MK-6240, Neurocognitive testing

Eligibility

You can join if…

Open to people ages 60 years and up

  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.

You CAN'T join if...

  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.

Location

  • University of California, Irvine accepting new patients
    Irvine California 92697 United States

Lead Scientist at UC Irvine

  • Michael A Yassa, PhD
    Professor and Associate Dean of Diversity, Equity and Inclusion, Neurobiology & Behavior, School of Biological Sciences. Authored (or co-authored) 179 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Irvine
Links
BEACoN (Biomarker Exploration in Aging, Cognition, and Neurodegeneration) study website
ID
NCT03860857
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 300 study participants
Last Updated
Contact us about this trial