NCT03860857 Biomarker Exploration in Aging, Cognition and Neurodegeneration
| NCT ID | NCT03860857 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | University of California, Irvine |
| Condition | Alzheimer Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 300 participants |
| Start Date | 2018-05-01 |
| Primary Completion | 2026-12-22 |
Trial Parameters
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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 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.
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
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