MRI and PET Biomarkers for Cognitive Decline in Older Adults

  • STATUS
    Recruiting
  • End date
    Dec 22, 2024
  • participants needed
    200
  • sponsor
    University of California, Irvine
Updated on 29 April 2021

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.

Description

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.

Details
Condition Dementia, Alzheimer's Disease, Cognitive Impairment, Cognitive Dysfunction, Cognitive Decline, Cognitive Impairments, Mental Deterioration, neurocognitive disturbance, alzheimer, dementia alzheimer's type
Treatment MRI, Neurocognitive testing, Amyloid PET scan, Tau PET scan using MK-6240
Clinical Study IdentifierNCT03860857
SponsorUniversity of California, Irvine
Last Modified on29 April 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Between the ages of 60 and 85
Speaks fluent English
Visual and auditory acuity adequate for neuropsychological and computerized testing
Good general health with no disease(s) expected to interfere with the study
Willing and able to participate for the duration of the study and in all study procedures including MRI and PET
Normal cognition defined as a Clinical Dementia Rating of 0 and a Mini-Mental State Examination score of 27 or higher

Exclusion Criteria

Significant co-morbid neurologic disease such as Parkinson's disease, multiple sclerosis, brain cyst, tumor or aneurysm
Major health conditions such as uncontrolled diabetes mellitus, uncontrolled hypertension, nutritional deficiency or uncontrolled thyroid disease
Significant psychiatric disorders such as schizophrenia, bipolar disorder, anxiety disorder, major depressive disorder, or attention-deficit hyperactivity disorder
ADRC consensus diagnosis of dementia or mild cognitive impairment
Cognitive impairment when tested at baseline (defined as a score on any neuropsychological test of 1.5 SDs or more outside the age norm)
Alcohol or substance abuse or dependence within the past 2 years (DSM-IV criteria)
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
PET contraindications, e.g. significant prior radiation exposure and pregnancy
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