We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

APOE in the Predisposition to, Protection From, and Prevention of Alzheimer's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04994847
Recruitment Status : Recruiting
First Posted : August 6, 2021
Last Update Posted : August 6, 2021
Sponsor:
Collaborator:
Mayo Clinic
Information provided by (Responsible Party):
Banner Health

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The purpose of this study is to track changes in the brain related to Alzheimer's disease. The results from this study will be used to develop new approaches to prevent or delay the onset of memory and thinking problems associated with Alzheimer's.

Condition or disease Intervention/treatment
Alzheimer Disease Drug: Amyloid and Tau PET

Detailed Description:

This study aims to establish, use, and extensively share a comprehensive longitudinal resource of genetic, non-genetic, and cognitive data, brain imaging and fluid biomarker measurements of amyloid-β, tau pathophysiology, neurodegeneration, and inflammation and biological samples to advance the study of cognitively unimpaired older adults at six levels of genetic risk for Alzheimer's disease due to their APOE genotype including understudied APOE2 and APOE4 homozygotes (HMs) at the lowest and highest risk and those APOE4 HMs and heterozygotes (HTs) who remain unimpaired at older ages due to unknown protective factors and spared pathophysiological effects despite their genetic risk.

Each participant will provide blood samples for clinical lab analysis, DNA, RNA, plasma, serum, and peripheral blood mononuclear cells (PBMCs) every 12 months; amyloid and tau PET scans, a nearly one hour battery of MRIs, a lumbar puncture (LP) for the collection of CSF samples, and a comprehensive battery of cognitive, behavioral, risk factor, and other assessments every 24 months. Extracted DNA will be used to characterize the participant's APOE genotype, screen for rare APOE variants that might make them eligible for other studies, and perform whole genome sequencing (WGS) and genome-wide genotyping.

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: APOE in the Predisposition to, Protection From, and Prevention of Alzheimer's Disease
Actual Study Start Date : May 1, 2021
Estimated Primary Completion Date : June 30, 2026
Estimated Study Completion Date : June 30, 2026

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
APOE Unimpaired Observational Trial
300 participants who are cognitively unimpaired; Yearly procedures: blood draw Every Two Year Procedures: cognitive and clinical assessments, CSF collection, MRI, and Tau and Amyloid PET scans
 Drug: Amyloid and Tau PET
NAV4694 and MK6240 PET scans completed every two years


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Amyloid PET Scan [ Time Frame: 5 years ]
    The study will acquire NAV4694, a radiotracer specific to amyloid, PET scans to monitor total amyloid levels in the brain.

  2. Tau PET Scan [ Time Frame: 5 years ]
    The study will acquire MK6240, a radiotracer specific to Tau, PET scans to monitor total tau levels in the brain.

  3. MRI [ Time Frame: 5 years ]
    The study will acquire 3T MRI to look at brain volume


Biospecimen Retention:   Samples With DNA
Blood will be collected annually and CSF collected every two years.

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   50 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
For the Arizona APOE Cohort, we will establish a new longitudinal cohort of 300 cognitively unimpaired males and non-pregnant females, 50-90 years of age at the time of enrollment who will be enrolled based on their APOE genotype, age, other eligibility criteria, consent to participate in virtually all study procedures, and consent to provide a shared resource of anonymized data and biological samples for the research community. Participants will include 50 individuals with each of the six common APOE genotypes (known as 2/2, 2/3, 3/3, 2/4, 3/4, and 4/4) who are matched by age decile, sex, and educational level. Participants will not receive information about their APOE genotype from this project97 and will be studied under the auspicious of a single Institutional Review Board (IRB).
Criteria

Inclusion Criteria:

  • Male or female age 50 to 90 years old in good general health with no diseases expected to interfere with the study.
  • Willing to undergo health and cognitive assessments, brain imaging sessions (MRI and PET), and collection and banking of blood with venipuncture and CSF by lumbar puncture for genetic research, biomarker research, and DNA banking.
  • Determined to be cognitively unimpaired by PI (mechanisms may include verbal interview, participant or study partner reports or specific scores on cognitive assessments)

Exclusion Criteria:

  • Participants with significant health issues or medical diseases that may interfere with participation, including infectious diseases that pose a risk to study personnel.
  • For PET or MRI: Female participant who is pregnant, lactating, or of childbearing potential without a negative pregnancy test or being two years postmenopausal or surgically sterile.
  • For MRI: Any contraindication for MRI including, but not limited to, pacemaker, aneurysm clips, artificial heart valves, ear implants, metal fragments or foreign objects in the eyes, skin, or body.
  • For CSF collection: Medical or surgical contraindication for lumbar puncture (e.g. on anti-coagulant therapy or had prior lumbar spinal surgery).
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04994847


Contacts
Layout table for location contacts
Contact: Jennifer Craig-Muller 602.839.6538 jennifer.craig-muller@bannerhealth.com

Locations
Layout table for location information
United States, Arizona
Banner Alzheimer's Institute Recruiting
Phoenix, Arizona, United States, 85006
Contact: Katie DeMarco    602-839-2033    Kathryn.DeMarco@bannerhealth.com   
Sponsors and Collaborators
Banner Health
Mayo Clinic
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Banner Health
ClinicalTrials.gov Identifier: NCT04994847    
Other Study ID Numbers: NIH-APOE-R01-001
First Posted: August 6, 2021    Key Record Dates
Last Update Posted: August 6, 2021
Last Verified: July 2021

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Alzheimer Disease
Disease Susceptibility
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Disease Attributes
Pathologic Processes