Summary

for people ages 60-85 (full criteria)
healthy people welcome
at UC Irvine
study started
estimated completion
Michael A Yassa, PhD(uci)

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.

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 Cognitive Dysfunction Amyloid PET scan Tau PET scan using MK-6240 Neurocognitive testing Age 60-65 ApoE e4+ Age 66-70 ApoE e4- Age 66-70 ApoE e4+ Age 71-75 ApoE e4- Age 71-75 ApoE e4+ Age 76-80 ApoE e4- Age 76-80 ApoE e4+ Age 81-85 ApoE e4- Age 81-85 ApoE e4+

Eligibility

You can join if…

Open to people ages 60-85

  1. Between the ages of 60 and 85;
  2. Speaks fluent English;
  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 27 or higher.

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 such as uncontrolled diabetes mellitus, uncontrolled hypertension, nutritional deficiency or uncontrolled thyroid disease;
  3. Significant psychiatric disorders such as schizophrenia, bipolar disorder, anxiety disorder, major depressive disorder, or attention-deficit hyperactivity disorder;
  4. ADRC consensus diagnosis of dementia or mild cognitive impairment;
  5. Cognitive impairment when tested at baseline (defined as a score on any neuropsychological test of 1.5 SDs or more outside the age norm);
  6. Alcohol or substance abuse or dependence within the past 2 years (DSM-IV criteria);
  7. 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;
  8. 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

  • Michael A Yassa, PhD (uci)
    Associate Professor, Neurobiology & Behavior. Authored (or co-authored) 93 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Irvine
Links
Yassa Lab website
ID
NCT03860857
Phase
Phase 3
Study Type
Interventional
Last Updated