Risk Prediction for Alzheimer Dementia With Brain Imaging and Genetics

NCT03641768 | Withdrawn FDA Device

• 1 other identifier: Pro00100030
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to learn about how trauma, posttraumatic stress disorder (PTSD), and mild traumatic brain injury that can occur during deployment affect the brain. The investigators also want to learn how PTSD and mild traumatic brain injury can affect the chance of developing Alzheimer disease later in life. The investigators will study this by using magnetic resonance imaging and positron emission tomography scans to obtain pictures of the brain.

Conditions

Alzheimer Dementia; Posttraumatic Stress Disorder; Traumatic Brain Injury

Keywords

Alzheimer Dementia; PTSD; MRI

Outcome Measures

Primary Outcomes (3)

• Cortical thickness as measured by MRI scans

  Baseline

• Beta amyloid plaques as measured by PET scans

  Baseline

• Tau proteins as measured by PET scans

  Baseline

Study Arms (4)

Healthy volunteers

ACTIVE COMPARATOR

Volunteers with no trauma history

Device: MRI; Device: PET; Device: 18F-Florbetapir; Device: Radioligand 18F-AV-1451

Trauma only

ACTIVE COMPARATOR

Volunteers that do not have PTSD but have had similar trauma to those with PTSD

Device: MRI; Device: PET; Device: 18F-Florbetapir; Device: Radioligand 18F-AV-1451

PTSD only

ACTIVE COMPARATOR

Volunteers with PTSD but no traumatic brain injury

Device: MRI; Device: PET; Device: 18F-Florbetapir; Device: Radioligand 18F-AV-1451

PTSD and TBI

ACTIVE COMPARATOR

Volunteers with PTSD and mild traumatic brain injury

Device: MRI; Device: PET; Device: 18F-Florbetapir; Device: Radioligand 18F-AV-1451

Interventions

MRI DEVICE

You will be asked to undergo a scan of your brain called an MRI. The MRI scan can measure the functioning of your brain.

Healthy volunteers; PTSD and TBI; PTSD only; Trauma only

PET DEVICE

You will be asked to undergo a scan of brain called a positron emission tomography (PET) scan. The PET scan is a test that uses radioactive glucose (sugar) and a computer to create images of how your brain is functioning. Abnormal cells in the body use glucose at a different rate than normal cells and this allows the scanner to create a detailed picture of how your body is working.

Healthy volunteers; PTSD and TBI; PTSD only; Trauma only

18F-Florbetapir DEVICE

At the Duke University PET Center you will be in a quiet dimly lit space with only ambient room sound, with your eyes open and ears unplugged. Your safety will be monitored by a physician and nurse. 18F-florbetapir will be administered to you as a bolus injection through a peripheral vein followed by a flush and 10 minute continuous brain PET imaging will begin 50 minutes post-injection.

Also known as: PET tracer for Amyloid-beta

Healthy volunteers; PTSD and TBI; PTSD only; Trauma only

Radioligand 18F-AV-1451 DEVICE

At the Duke University PET Center you will be in a quiet dimly lit space with only ambient room sound, with your eyes open and ears unplugged. Your safety will be monitored by a physician and nurse. 18F-florbetapir will be administered to you as a bolus injection through a peripheral vein followed by a flush and 10 minute continuous brain PET imaging will begin 50 minutes post-injection.

Also known as: PET tracer for Tau protein

Healthy volunteers; PTSD and TBI; PTSD only; Trauma only

Eligibility Criteria

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

You may qualify if:

• Age 18 to 65
• Previously enrolled in studies of OEF/OIF veterans by the same investigators
• Free of implanted metal objects or mental shards in eyes
• Fluent in English and capable of consenting

You may not qualify if:

• Axis I disorders other than Major Depressive Disorder or PTSD
• Current substance abuse or lifetime substance dependence (other than nicotine)
• High risk for suicide
• Claustrophobia
• Neurological disorders
• Learning disability or developmental delay
• Major medical conditions

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Durham VA

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Alzheimer Disease; Stress Disorders, Post-Traumatic; Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Brain Injuries; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Rajendra Morey, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2018
• First Posted: August 22, 2018
• Study Start: January 1, 2019
• Primary Completion: January 1, 2021
• Study Completion: January 1, 2021
• Last Updated: October 16, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)