Biomarker Exploration in Aging, Cognition and Neurodegeneration

Part of paid clinical trials in Irvine, California.

Sponsor
University of California, Irvine
Study ID
NCT03860857
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
60 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Amyloid PET scan — RADIATION
    Amyloid Positron Emission Tomography scan using radio tracer florbetapir-F18
  • Tau PET scan using MK-6240 — DRUG
    Tau Positron Emission Tomography scan using radio tracer MK-6240
  • Neurocognitive testing — BEHAVIORAL
    A battery of clinical neuropsychological assessments and computerized cognitive tasks will be used to test participants' memory and cognitive abilities.
  • MRI — OTHER
    High-resolution structural, functional, and diffusion Magnetic Resonance Imaging scans will be collected during the study.

Study Details

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 Dates

Start date
May 1, 2018
Status verified
Jan 2026
Primary completion
Dec 22, 2026
Completion
Dec 22, 2027

Study Design

Enrollment
300 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Experimental: Age 60-65 ApoE e4+
    Participants in this cohort are between the ages of 60-65 and are ApoE e4 carriers. All participants in this cohort will complete the Amyloid PET scan, Tau PET scan using MK-6240, MRI scans, and neurocognitive testing.
  • Experimental: Age 66-70 ApoE e4-
    Participants in this cohort are between the ages of 66-70 and are not ApoE e4 carriers. All participants in this cohort will complete the Amyloid PET scan, Tau PET scan using MK-6240, MRI scans, and neurocognitive testing.
  • Experimental: Age 66-70 ApoE e4+
    Participants in this cohort are between the ages of 66-70 and are ApoE e4 carriers. All participants in this cohort will complete the Amyloid PET scan, Tau PET scan using MK-6240, MRI scans, and neurocognitive testing.
  • Experimental: Age 71-75 ApoE e4-
    Participants in this cohort are between the ages of 71-75 and are not ApoE e4 carriers. All participants in this cohort will complete the Amyloid PET scan, Tau PET scan using MK-6240, MRI scans, and neurocognitive testing.
  • Experimental: Age 71-75 ApoE e4+
    Participants in this cohort are between the ages of 71-75 and are ApoE e4 carriers. All participants in this cohort will complete the Amyloid PET scan, Tau PET scan using MK-6240, MRI scans, and neurocognitive testing.
  • Experimental: Age 76-80 ApoE e4-
    Participants in this cohort are between the ages of 76-80 and are not ApoE e4 carriers. All participants in this cohort will complete the Amyloid PET scan, Tau PET scan using MK-6240, MRI scans, and neurocognitive testing.
  • Experimental: Age 76-80 ApoE e4+
    Participants in this cohort are between the ages of 76-80 and are ApoE e4 carriers. All participants in this cohort will complete the Amyloid PET scan, Tau PET scan using MK-6240, MRI scans, and neurocognitive testing.
  • Experimental: Age 81+ ApoE e4-
    Participants in this cohort are between the ages of 81-85 and are not ApoE e4 carriers. All participants in this cohort will complete the Amyloid PET scan, Tau PET scan using MK-6240, MRI scans, and neurocognitive testing.
  • Experimental: Age 81+ ApoE e4+
    Participants in this cohort are between the ages of 81-85 and are ApoE e4 carriers. All participants in this cohort will complete the Amyloid PET scan, Tau PET scan using MK-6240, MRI scans, and neurocognitive testing.

Primary Outcome Measure

Change in Clinical Dementia Rating - Sum of Box Score [ Time Frame: Years 4 and 5 of the grant ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California, IrvineIrvineCalifornia92697
Evelyn Chang, BA
[email protected]
949-824-0904
Novelle Meza, BS
[email protected]
949-824-5049
Michael A Yassa, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Irvine, CA

By condition
Alzheimer's disease
By specialty
NeurologyDementia careBrain disordersGeriatrics
By research site
University of California, Irvine· Irvine, CA

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