MRI and PET Biomarkers for Cognitive Decline in Older Adults



Status:Recruiting
Conditions:Alzheimer Disease, Cognitive Studies, Cognitive Studies, Cognitive Studies, Cognitive Studies
Therapuetic Areas:Neurology, Psychiatry / Psychology
Healthy:No
Age Range:60 - 85
Updated:3/13/2019
Start Date:May 1, 2018
End Date:December 22, 2024
Contact:Myra S Larson, BA
Email:mslarson@uci.edu
Phone:949-824-0314

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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.

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.

Inclusion Criteria:

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.

Exclusion Criteria:

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.
We found this trial at
1
site
Irvine, California 92697
949-824-5011
Principal Investigator: Michael A Yassa, PhD
Phone: 949-824-0314
University of California, Irvine Since 1965, the University of California, Irvine has combined the strengths...
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mi
from
Irvine, CA
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