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

NCT04994847 | Enrolling By Invitation DMC FDA Drug

• 1 other identifier: NIH-APOE-R01-001
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer Disease

Outcome Measures

Primary Outcomes (3)

• Amyloid PET Scan

  The study will acquire NAV4694, a radiotracer specific to amyloid, PET scans to monitor total amyloid levels in the brain.

  5 years

• Tau PET Scan

  The study will acquire MK6240, a radiotracer specific to Tau, PET scans to monitor total tau levels in the brain.

  5 years

• MRI

  The study will acquire 3T MRI to look at brain volume

  5 years

Study Arms (1)

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

Interventions

Amyloid and Tau PET DRUG

NAV4694 and MK6240 PET scans completed every two years

APOE Unimpaired Observational Trial

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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)

You may not qualify if:

• 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).

Sponsors & Collaborators

• Banner Health: lead
• Mayo Clinic: collaborator

Study Sites (1)

Banner Alzheimer's Institute

Phoenix, Arizona, 85006, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood will be collected annually and CSF collected every two years.

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Amyloid

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Multiprotein Complexes; Macromolecular Substances; Proteins; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2021
• First Posted: August 6, 2021
• Study Start: May 1, 2021
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: July 20, 2025

Record last verified: 2025-07

Locations

US (1)