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MRI + PET Scans for Cognitive Impairment (BEACoN Trial)
Phase 3
Recruiting
Led By Michael A Yassa, PhD
Research Sponsored by University of California, Irvine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Aged 60 and above
Be older than 18 years old
Must not have
Major health conditions such as uncontrolled diabetes mellitus, uncontrolled hypertension, nutritional deficiency or uncontrolled thyroid disease
Significant co-morbid neurologic disease such as Parkinson's disease, multiple sclerosis, brain cyst, tumor or aneurysm
Timeline
Screening 3 weeks
Treatment Varies
Follow Up years 4 and 5 of the grant
Awards & highlights
Summary
This trial is studying how well MRI, PET, and cognitive testing work in detecting changes in the brain that may happen before someone shows symptoms of cognitive decline. They will also look at tau protein in the brain with a PET scan and an investigational drug.
Who is the study for?
This trial is for people aged 60 or older who speak English or Spanish, have good vision and hearing for tests, are in overall good health without diseases that could affect the study. They must not have significant neurological conditions like Parkinson's disease, major psychiatric disorders, uncontrolled medical issues like diabetes or hypertension, metal implants incompatible with MRI scans, nor be pregnant.
What is being tested?
Researchers are studying how brain imaging (MRI and PET scans) and cognitive tests can detect early changes linked to memory loss as we age. The study includes a special PET scan using MK-6240 to see if tau protein tangles in the brain relate to cognitive decline—a sign of Alzheimer's disease.
What are the potential side effects?
While there aren't direct side effects from the interventions since they're diagnostic tools rather than medications, participants may experience discomfort during MRI or PET procedures. There's also a small risk of allergic reaction to the tracer used in PET scans.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 60 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have uncontrolled diabetes, high blood pressure, nutritional deficiencies, or thyroid issues.
Select...
I have a serious brain or nerve condition like Parkinson's or MS.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ years 4 and 5 of the grant
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~years 4 and 5 of the grant
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Clinical Dementia Rating - Sum of Box Score
Secondary study objectives
Change in entorhinal cortical thickness
Change in lure discrimination index - objects
Change in lure discrimination index - spatial
+3 moreTrial Design
9Treatment groups
Experimental Treatment
Group I: Age 81+ ApoE e4-Experimental Treatment4 Interventions
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.
Group II: Age 81+ ApoE e4+Experimental Treatment4 Interventions
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.
Group III: Age 76-80 ApoE e4-Experimental Treatment4 Interventions
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.
Group IV: Age 76-80 ApoE e4+Experimental Treatment4 Interventions
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.
Group V: Age 71-75 ApoE e4-Experimental Treatment4 Interventions
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.
Group VI: Age 71-75 ApoE e4+Experimental Treatment4 Interventions
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.
Group VII: Age 66-70 ApoE e4-Experimental Treatment4 Interventions
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.
Group VIII: Age 66-70 ApoE e4+Experimental Treatment4 Interventions
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.
Group IX: Age 60-65 ApoE e4+Experimental Treatment4 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Neurocognitive testing
2017
N/A
~70
Find a Location
Who is running the clinical trial?
National Institute on Aging (NIA)NIH
1,733 Previous Clinical Trials
28,054,803 Total Patients Enrolled
35 Trials studying Cognitive Decline
27,207 Patients Enrolled for Cognitive Decline
University of California, IrvineLead Sponsor
559 Previous Clinical Trials
1,929,808 Total Patients Enrolled
Michael A Yassa, PhDPrincipal InvestigatorUniversity of California, Irvine
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I speak English or Spanish fluently.You have been diagnosed with dementia or mild cognitive impairment by a specialist.You cannot have an MRI if you have certain medical implants or metal in your body. If you are pregnant or trying to get pregnant, you cannot participate.You do not have memory or thinking problems, and you score 27 or higher on a memory and thinking test.I am in good health with no conditions that could affect the study.You have had problems with alcohol or drugs in the past 2 years.I am 60 years old or older.I do not have uncontrolled diabetes, high blood pressure, nutritional deficiencies, or thyroid issues.You have had a lot of radiation exposure in the past or are pregnant.I can see and hear well enough for tests on a computer.I have a serious brain or nerve condition like Parkinson's or MS.You have a serious mental illness like schizophrenia, bipolar disorder, anxiety disorder, major depressive disorder, or attention-deficit hyperactivity disorder.You have been tested and found to have significant problems with memory or thinking.
Research Study Groups:
This trial has the following groups:- Group 1: Age 76-80 ApoE e4-
- Group 2: Age 66-70 ApoE e4-
- Group 3: Age 71-75 ApoE e4-
- Group 4: Age 60-65 ApoE e4+
- Group 5: Age 71-75 ApoE e4+
- Group 6: Age 81+ ApoE e4-
- Group 7: Age 81+ ApoE e4+
- Group 8: Age 76-80 ApoE e4+
- Group 9: Age 66-70 ApoE e4+
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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