Biomarker Exploration in Aging, Cognition and Neurodegeneration

Alzheimer Disease Clinical Trial

— BEACoN  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03860857
• Other study ID #: 20173832
• Secondary ID: R01AG053555-022R
• Status: Recruiting
• Phase: Phase 3
• Start date: May 1, 2018
• Est. completion date: December 22, 2027

Study information

• Verified date: December 2023
• Source: University of California, Irvine
• Contact: Alyssa Harris, BA
• Phone: 949-824-0904
• Email: beacon[@]uci.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This study investigates the relationship between Alzheimer's disease (AD) pathology, brain structure and function, as well as cognition in non-demented older adults. The goal is to develop a more complete understanding of the factors that lead to cognitive decline in the elderly and progression to AD. The investigators will enroll 200 cognitively intact adults between the ages of 60-85 years old from the UCI Alzheimer's Disease Research Center or directly from the local community. Study procedures will include: 1) PET amyloid scans with Amyvid™ radiotracer (florbetapir-F18) and PET tau scans with [18F]MK6240 radiotracer; 2) High-resolution structural, functional, and diffusion MRI; and 3) Cognitive examinations. The investigators will track cognitive outcomes through longitudinal monitoring. Amyloid imaging will only be conducted once in the study at baseline, and MRI and tau PET imaging will be at baseline and Year 1. The investigators aim to identify the best combination of tests for predicting longitudinal cognitive/clinical decline. The proposed study will significantly inform the understanding of cognitive decline in the aging brain and allow investigators to better define preclinical AD and make recommendations for future intervention trials.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 22, 2027
• Est. primary completion date: December 22, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 105 Years

Eligibility

Inclusion Criteria:

1. Aged 60 or older;

2. Speaks fluent English or Spanish;

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 25 or higher. FAST Stage 1 or 2.

7. Subjective memory or other cognitive complaints will be included.

Exclusion Criteria:

1. Significant co-morbid neurologic disease such as Parkinson's disease, multiple sclerosis, brain cyst, tumor or aneurysm;

2. 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;

3. 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;

4. Existing diagnosis of dementia or mild cognitive impairment;

5. Alcohol or substance abuse or dependence within the past 2 years (DSM-IV criteria);

6. 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;

7. PET contraindications, e.g. significant prior radiation exposure and pregnancy.

Related Conditions & MeSH terms

• Alzheimer Disease
• Cognitive Decline
• Cognitive Dysfunction
• Cognitive Impairment
• Nerve Degeneration

Intervention

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.

Locations

Country	Name	City	State
United States	University of California, Irvine	Irvine	California

Sponsors (2)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Clinical Dementia Rating - Sum of Box Score	A measure of cognitive/clinical decline	Years 4 and 5 of the grant
Secondary	Change in lure discrimination index - objects	Key measure of performance on the object pattern separation task	Years 4 and 5 of the grant
Secondary	Change in lure discrimination index - spatial	Key measure of performance on the spatial pattern separation task	Years 4 and 5 of the grant
Secondary	Change in lure discrimination index - temporal	Key measure of performance on the temporal pattern separation task	Years 4 and 5 of the grant
Secondary	Change in entorhinal cortical thickness	Key measure of structural decline on MRI scans	Years 4 and 5 of the grant
Secondary	Change in perforant path integrity	Key measure of structural connectivity decline on MRI scans	Years 4 and 5 of the grant
Secondary	Change in tau spatial distribution - advancing Braak stage	Key measure of tau spatial spread on tau PET scans	Years 4 and 5 of the grant

External Links

•   BEACoN (Biomarker Exploration in Aging, Cognition, and Neurodegeneration) study website