Biomarker Exploration in Aging, Cognition and Neurodegeneration

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.

Conditions

• Alzheimer Disease
• Cognitive Impairment
• Cognitive Decline

Interventions

RADIATION

Amyloid PET scan

Amyloid Positron Emission Tomography scan using radio tracer florbetapir-F18

DRUG

Tau PET scan using MK-6240

Tau Positron Emission Tomography scan using radio tracer MK-6240

BEHAVIORAL

Neurocognitive testing

A battery of clinical neuropsychological assessments and computerized cognitive tasks will be used to test participants' memory and cognitive abilities.

OTHER

MRI

High-resolution structural, functional, and diffusion Magnetic Resonance Imaging scans will be collected during the study.

Sponsors & Collaborators

• National Institute on Aging (NIA)

  collaborator NIH

• University of California, Irvine

  lead OTHER

Principal Investigators

• Michael A Yassa, PhD · University of California, Irvine

• Liv C McMillan, BS, CCRP · University of California, Irvine

Study Design

Allocation

NON_RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

60 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2018-05-01

Primary Completion

2026-12-22

Completion

2027-12-22

FDA Drug

Yes

Countries

• United States

Study Locations