The BEACoN Study- Biomarker Exploration in Aging, Cognition and Neurodegeneration

Who is this study for? Older adult patients with Alzheimer's Disease
Status: Recruiting
Location: See location...
Intervention Type: Behavioral, Drug, Other, Radiation
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 60
Healthy Volunteers: t
View:

• 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.

Locations
United States
California
University of California, Irvine
RECRUITING
Irvine
Contact Information
Primary
Evelyn Chang, BA
beacon@uci.edu
949-824-0904
Backup
Novelle Meza, BS
njmeza@uci.edu
949-824-5049
Time Frame
Start Date: 2018-05-01
Estimated Completion Date: 2027-12-22
Participants
Target number of participants: 300
Treatments
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.
Authors
Michael A Yassa
Related Therapeutic Areas
Sponsors
Leads: University of California, Irvine
Collaborators: National Institute on Aging (NIA)

This content was sourced from clinicaltrials.gov