Biomarker Exploration in Aging, Cognition and Neurodegeneration

Recruiting now · Phase 3

Conditions studied: Alzheimer Disease, Cognitive Impairment, Cognitive Decline

In brief

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.

Key facts

Study ID

NCT03860857

Run by

University of California, Irvine

People needed

300

Starts

2018-05-01

Expected to finish

2027-12-22

Last updated by the study team

2026-01-23

Who can join

Age: 60 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of California, Irvine — Irvine, California, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.