RECRUITING

Biomarker Exploration in Aging, Cognition and Neurodegeneration

Conditions

Alzheimer Disease Cognitive Impairment Cognitive Decline mild cognitive impairment biomarker MRI PET

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2018-05-01

Study Completion:2027-12-22

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT03860857

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:60 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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.

Inclusion Criteria

Exclusion 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.

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.

Contacts and Locations

Study Contact

Evelyn Chang, BA

CONTACT

949-824-0904

beacon@uci.edu

Novelle Meza, BS

CONTACT

949-824-5049

njmeza@uci.edu

Principal Investigator

Michael A Yassa, PhD

PRINCIPAL_INVESTIGATOR

University of California, Irvine

Liv C McMillan, BS, CCRP

STUDY_DIRECTOR

University of California, Irvine

Study Locations (Sites)

University of California, Irvine

Irvine, California, 92697

United States

Collaborators and Investigators

Sponsor: University of California, Irvine

Michael A Yassa, PhD, PRINCIPAL_INVESTIGATOR, University of California, Irvine
Liv C McMillan, BS, CCRP, STUDY_DIRECTOR, University of California, Irvine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-05-01

Study Completion Date2027-12-22

Study Record Updates

Study Start Date2018-05-01

Study Completion Date2027-12-22

Terms related to this study

Keywords Provided by Researchers

Alzheimer disease
cognitive impairment
mild cognitive impairment
biomarker
MRI
PET

Additional Relevant MeSH Terms

Alzheimer Disease
Cognitive Impairment
Cognitive Decline