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Biomarker Exploration in Aging, Cognition and Neurodegeneration

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
60 Years and older
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: MRI scans, PET scans

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "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."
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether MRI and PET brain scans and thinking tests can find early brain changes before thinking and memory decline. It is for adults age 60 or older with normal thinking and memory test results, including those with memory concerns. An extra part uses an injected study drug called MK-6240 during PET scans to look at tau, a protein that forms tangles linked to Alzheimer's disease.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are age 60 or older.
  • You speak English or Spanish fluently.
  • You can see and hear well enough to take thinking and computer tests.
  • You are in good general health, with no illness expected to interfere with the study.
  • You are willing and able to stay in the study and complete all steps, including MRI and PET brain scans.
  • Your thinking and memory test results meet these limits: Clinical Dementia Rating of 0, Mini-Mental State Examination score of at least 25, and FAST stage 1 or 2.
  • You may have concerns about your memory or thinking and still join if you meet the other requirements.

Who can't join

  • You have a serious brain or nerve disease, such as Parkinson's disease, multiple sclerosis, a brain cyst or tumor, or an aneurysm (a bulge in a blood vessel).
  • You have a major health condition. Type 2 diabetes, high cholesterol, and high blood pressure do not rule you out.
  • You have a serious mental health disorder, such as schizophrenia, bipolar disorder, or ADHD (attention-deficit hyperactivity disorder). Depression and anxiety do not rule you out.
  • You have been diagnosed with dementia or mild cognitive impairment (thinking or memory problems).
  • You have had alcohol or drug abuse or dependence within the past 2 years.
  • You cannot safely have an MRI because of items such as a pacemaker, aneurysm clips, an artificial heart valve, an ear implant, or metal in your body.
  • You are pregnant or trying to get pregnant.
  • You cannot safely have a PET scan, for example because of significant past radiation exposure.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (1)

CA