Status:
RECRUITING
Biomarker Exploration in Aging, Cognition and Neurodegeneration
Lead Sponsor:
University of California, Irvine
Collaborating Sponsors:
National Institute on Aging (NIA)
Conditions:
Alzheimer Disease
Cognitive Impairment
Eligibility:
All Genders
60+ years
Phase:
PHASE3
Brief 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 ...
Detailed 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 comp...
Eligibility Criteria
Inclusion
- Aged 60 or older;
- Speaks fluent English or Spanish;
- 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 25 or higher. FAST Stage 1 or 2.
- Subjective memory or other cognitive complaints will be included.
Exclusion
- Significant co-morbid neurologic disease such as Parkinson's disease, multiple sclerosis, brain cyst, tumor or aneurysm;
- 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;
- 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;
- Existing diagnosis of dementia or mild cognitive impairment;
- 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.
Key Trial Info
Start Date :
May 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 22 2027
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT03860857
Start Date
May 1 2018
End Date
December 22 2027
Last Update
November 1 2024
Active Locations (1)
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1
University of California, Irvine
Irvine, California, United States, 92697