MRI and PET Biomarkers for Cognitive Decline in Older Adults

• Status: Recruiting
• Trial end date: 2024-12-22
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of California, Irvine
• Collaborator: National Institute on Aging (NIA)

Criteria

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.