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

Plain English Summary

Biomarker Exploration in Aging, Cognition and Neurodegeneration is a Phase 3 clinical trial sponsored by University of California, Irvine studying Alzheimer Disease, Cognitive Impairment, Cognitive Decline. Tests MRI, PET, and cognitive tests to detect early signs of Alzheimer's disease. For adults 60 and older with memory or cognitive complaints. Participation involves MRI, PET scans, and cognitive testing over 5 years. Alternative tests include standard clinical assessments. The trial aims to enroll 300 participants.

Official 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.

Who Can Participate

Here is what you need to know about eligibility for this trial. Aged 60 or older, fluent in English or Spanish, good general health. No significant neurologic or psychiatric disorders, no dementia or MCI. No MRI or PET contraindications, not pregnant or trying to get pregnant. This trial is studying Alzheimer Disease, Cognitive Impairment, Cognitive Decline, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.

What They're Measuring

The primary outcome measures changes in brain structure and function, helping patients understand their cognitive health over time. The specific primary outcome measures are: Change in Clinical Dementia Rating - Sum of Box Score (Years 4 and 5 of the grant). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This trial is in Phase 3, the final and most rigorous stage before seeking FDA approval. Phase 3 trials involve 300-3,000+ patients across multiple sites and compare the new treatment directly against the current standard of care. These pivotal trials generate the evidence needed for regulatory review. About 58% of Phase 3 drugs receive FDA approval. Successful Phase 3 results typically lead to a New Drug Application submission.

Why This Trial Matters

This trial fills a gap by focusing on early detection of Alzheimer's disease through advanced imaging techniques. As a Phase 3 trial, positive results could directly lead to FDA approval, making this treatment available to the broader patient population. This research targets Alzheimer Disease, Cognitive Impairment, Cognitive Decline, where improved treatment options are needed.

Investor Insight

Market size is large, with a high unmet need for early detection of Alzheimer's disease, and a competitive landscape with ongoing research. Phase 3 trials have approximately a 50-60% chance of gaining FDA approval if they reach this stage.

Is This Trial Right for Me?

Ask your doctor about your cognitive health and any concerns you have. Participation involves MRI, PET scans, and cognitive testing over 5 years. This trial is currently recruiting participants. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: NON_RANDOMIZED
• Model: PARALLEL
• Masking: NONE
• Enrollment: 300 participants

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.

Primary Outcomes

• Change in Clinical Dementia Rating - Sum of Box Score (Years 4 and 5 of the grant)

Secondary Outcomes

• Change in lure discrimination index - objects (Years 4 and 5 of the grant)
• Change in lure discrimination index - spatial (Years 4 and 5 of the grant)
• Change in lure discrimination index - temporal (Years 4 and 5 of the grant)
• Change in entorhinal cortical thickness (Years 4 and 5 of the grant)
• Change in perforant path integrity (Years 4 and 5 of the grant)

Full Eligibility 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.

Trial Locations

• University of California, Irvine, Irvine, California, United States

Frequently Asked Questions

Related Conditions

• Alzheimer Disease
• Cognitive Impairment
• Cognitive Decline
• Dementia
• Mild Cognitive Impairment
• Parkinson's Disease
• Multiple Sclerosis
• Neurodegeneration
• Cognitive Health
• Brain Imaging

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