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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

No Placebo-Only Group

Pivotal Trial

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 below

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I am 60 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have uncontrolled diabetes, high blood pressure, nutritional deficiencies, or thyroid issues.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and years 4 and 5 of the grant for reporting.

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 more

Awards & Highlights

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.

Trial 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

0 / 3Eligibility criteria met