Biomarker Exploration in Aging, Cognition and Neurodegeneration
NCT ID: NCT03860857
Last Updated: 2026-01-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
300 participants
INTERVENTIONAL
2018-05-01
2027-12-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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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.
Amyloid PET scan
Amyloid Positron Emission Tomography scan using radio tracer florbetapir-F18
Tau PET scan using MK-6240
Tau Positron Emission Tomography scan using radio tracer MK-6240
Neurocognitive testing
A battery of clinical neuropsychological assessments and computerized cognitive tasks will be used to test participants' memory and cognitive abilities.
MRI
High-resolution structural, functional, and diffusion Magnetic Resonance Imaging scans will be collected during the study.
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.
Amyloid PET scan
Amyloid Positron Emission Tomography scan using radio tracer florbetapir-F18
Tau PET scan using MK-6240
Tau Positron Emission Tomography scan using radio tracer MK-6240
Neurocognitive testing
A battery of clinical neuropsychological assessments and computerized cognitive tasks will be used to test participants' memory and cognitive abilities.
MRI
High-resolution structural, functional, and diffusion Magnetic Resonance Imaging scans will be collected during the study.
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.
Amyloid PET scan
Amyloid Positron Emission Tomography scan using radio tracer florbetapir-F18
Tau PET scan using MK-6240
Tau Positron Emission Tomography scan using radio tracer MK-6240
Neurocognitive testing
A battery of clinical neuropsychological assessments and computerized cognitive tasks will be used to test participants' memory and cognitive abilities.
MRI
High-resolution structural, functional, and diffusion Magnetic Resonance Imaging scans will be collected during the study.
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.
Amyloid PET scan
Amyloid Positron Emission Tomography scan using radio tracer florbetapir-F18
Tau PET scan using MK-6240
Tau Positron Emission Tomography scan using radio tracer MK-6240
Neurocognitive testing
A battery of clinical neuropsychological assessments and computerized cognitive tasks will be used to test participants' memory and cognitive abilities.
MRI
High-resolution structural, functional, and diffusion Magnetic Resonance Imaging scans will be collected during the study.
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.
Amyloid PET scan
Amyloid Positron Emission Tomography scan using radio tracer florbetapir-F18
Tau PET scan using MK-6240
Tau Positron Emission Tomography scan using radio tracer MK-6240
Neurocognitive testing
A battery of clinical neuropsychological assessments and computerized cognitive tasks will be used to test participants' memory and cognitive abilities.
MRI
High-resolution structural, functional, and diffusion Magnetic Resonance Imaging scans will be collected during the study.
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.
Amyloid PET scan
Amyloid Positron Emission Tomography scan using radio tracer florbetapir-F18
Tau PET scan using MK-6240
Tau Positron Emission Tomography scan using radio tracer MK-6240
Neurocognitive testing
A battery of clinical neuropsychological assessments and computerized cognitive tasks will be used to test participants' memory and cognitive abilities.
MRI
High-resolution structural, functional, and diffusion Magnetic Resonance Imaging scans will be collected during the study.
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.
Amyloid PET scan
Amyloid Positron Emission Tomography scan using radio tracer florbetapir-F18
Tau PET scan using MK-6240
Tau Positron Emission Tomography scan using radio tracer MK-6240
Neurocognitive testing
A battery of clinical neuropsychological assessments and computerized cognitive tasks will be used to test participants' memory and cognitive abilities.
MRI
High-resolution structural, functional, and diffusion Magnetic Resonance Imaging scans will be collected during the study.
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.
Amyloid PET scan
Amyloid Positron Emission Tomography scan using radio tracer florbetapir-F18
Tau PET scan using MK-6240
Tau Positron Emission Tomography scan using radio tracer MK-6240
Neurocognitive testing
A battery of clinical neuropsychological assessments and computerized cognitive tasks will be used to test participants' memory and cognitive abilities.
MRI
High-resolution structural, functional, and diffusion Magnetic Resonance Imaging scans will be collected during the study.
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.
Amyloid PET scan
Amyloid Positron Emission Tomography scan using radio tracer florbetapir-F18
Tau PET scan using MK-6240
Tau Positron Emission Tomography scan using radio tracer MK-6240
Neurocognitive testing
A battery of clinical neuropsychological assessments and computerized cognitive tasks will be used to test participants' memory and cognitive abilities.
MRI
High-resolution structural, functional, and diffusion Magnetic Resonance Imaging scans will be collected during the study.
Interventions
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Amyloid PET scan
Amyloid Positron Emission Tomography scan using radio tracer florbetapir-F18
Tau PET scan using MK-6240
Tau Positron Emission Tomography scan using radio tracer MK-6240
Neurocognitive testing
A battery of clinical neuropsychological assessments and computerized cognitive tasks will be used to test participants' memory and cognitive abilities.
MRI
High-resolution structural, functional, and diffusion Magnetic Resonance Imaging scans will be collected during the study.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
60 Years
ALL
Yes
Sponsors
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National Institute on Aging (NIA)
NIH
University of California, Irvine
OTHER
Responsible Party
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Michael Yassa
Professor
Principal Investigators
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Michael A Yassa, PhD
Role: PRINCIPAL_INVESTIGATOR
University of California, Irvine
Liv C McMillan, BS, CCRP
Role: STUDY_DIRECTOR
University of California, Irvine
Locations
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University of California, Irvine
Irvine, California, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Stevenson RF, Reagh ZM, Chun AP, Murray EA, Yassa MA. Pattern Separation and Source Memory Engage Distinct Hippocampal and Neocortical Regions during Retrieval. J Neurosci. 2020 Jan 22;40(4):843-851. doi: 10.1523/JNEUROSCI.0564-19.2019. Epub 2019 Nov 20.
Holbrook AJ, Tustison NJ, Marquez F, Roberts J, Yassa MA, Gillen DL; Alzheimer's Disease Neuroimaging Initiative section sign. Anterolateral entorhinal cortex thickness as a new biomarker for early detection of Alzheimer's disease. Alzheimers Dement (Amst). 2020 Aug 25;12(1):e12068. doi: 10.1002/dad2.12068. eCollection 2020.
Chappel-Farley MG, Mander BA, Neikrug AB, Stehli A, Nan B, Grill JD, Yassa MA, Benca RM. Symptoms of obstructive sleep apnea are associated with less frequent exercise and worse subjective cognitive function across adulthood. Sleep. 2022 Mar 14;45(3):zsab240. doi: 10.1093/sleep/zsab240.
Adams JN, Kim S, Rizvi B, Sathishkumar M, Taylor L, Harris AL, Mikhail A, Keator DB, McMillan L, Yassa MA. Entorhinal-Hippocampal Circuit Integrity Is Related to Mnemonic Discrimination and Amyloid-beta Pathology in Older Adults. J Neurosci. 2022 Nov 16;42(46):8742-8753. doi: 10.1523/JNEUROSCI.1165-22.2022. Epub 2022 Oct 27.
Adams JN, Marquez F, Larson MS, Janecek JT, Miranda BA, Noche JA, Taylor L, Hollearn MK, McMillan L, Keator DB, Head E, Rissman RA, Yassa MA. Differential involvement of hippocampal subfields in the relationship between Alzheimer's pathology and memory interference in older adults. Alzheimers Dement (Amst). 2023 Apr 5;15(2):e12419. doi: 10.1002/dad2.12419. eCollection 2023 Apr-Jun.
Related Links
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BEACoN (Biomarker Exploration in Aging, Cognition, and Neurodegeneration) study website
Other Identifiers
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20173832
Identifier Type: -
Identifier Source: org_study_id
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