Exploring biomarkers related to aging and cognitive decline
The BEACoN Study- Biomarker Exploration in Aging, Cognition and Neurodegeneration
This study is testing if new brain scans and memory tests can help find early signs of Alzheimer's disease in healthy older adults aged 60 to 85.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 60 Years and up |
| Sex | All |
| Sponsor | University of California, Irvine Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Irvine, California) |
| Trial ID | NCT03860857 on ClinicalTrials.gov |
What this trial studies
This research aims to understand the underlying factors contributing to cognitive decline and memory changes in older adults. The study will utilize advanced imaging techniques, including MRI and PET scans, alongside cognitive testing to detect early brain changes associated with Alzheimer's disease. A total of 200 cognitively healthy adults aged 60-85 will be enrolled, and their cognitive outcomes will be monitored over time. The study also includes an investigation of tau protein accumulation in the brain using a novel radiotracer, MK-6240, to better define preclinical Alzheimer's disease.
Who should consider this trial
Good fit: Ideal candidates are cognitively intact adults aged 60 or older who can participate in neuropsychological testing.
Not a fit: Patients with significant neurological diseases or major psychiatric disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved early detection and understanding of Alzheimer's disease, potentially guiding future interventions.
How similar studies have performed: Previous studies have shown promise in using imaging techniques to understand cognitive decline, but this specific approach with tau imaging is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Irvine, California
- University of California, Irvine — Irvine, California, United States (Recruiting)
Study contacts
- Principal investigator: Michael A Yassa, PhD — University of California, Irvine
- Study coordinator: Evelyn Chang, BA
- Email: beacon@uci.edu
- Phone: 949-824-0904
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.