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Clinical Trials/NCT03641768
NCT03641768WithdrawnNot Applicable

Risk Prediction for Alzheimer Dementia With Brain Imaging and Genetics

Duke University2 sites in 1 countryStarted: January 1, 2019Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Withdrawn
Locations
2
Primary Endpoint
Cortical thickness as measured by MRI scans

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Single Group
Primary Purpose
Basic Science
Masking
None

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Arms & Interventions

Healthy volunteers

Active Comparator

Volunteers with no trauma history

Intervention: MRI (Device)

Healthy volunteers

Active Comparator

Volunteers with no trauma history

Intervention: PET (Device)

Healthy volunteers

Active Comparator

Volunteers with no trauma history

Intervention: 18F-Florbetapir (Device)

Healthy volunteers

Active Comparator

Volunteers with no trauma history

Intervention: Radioligand 18F-AV-1451 (Device)

Trauma only

Active Comparator

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

Intervention: MRI (Device)

Trauma only

Active Comparator

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

Intervention: PET (Device)

Trauma only

Active Comparator

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

Intervention: 18F-Florbetapir (Device)

Trauma only

Active Comparator

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

Intervention: Radioligand 18F-AV-1451 (Device)

PTSD only

Active Comparator

Volunteers with PTSD but no traumatic brain injury

Intervention: MRI (Device)

PTSD only

Active Comparator

Volunteers with PTSD but no traumatic brain injury

Intervention: PET (Device)

PTSD only

Active Comparator

Volunteers with PTSD but no traumatic brain injury

Intervention: 18F-Florbetapir (Device)

PTSD only

Active Comparator

Volunteers with PTSD but no traumatic brain injury

Intervention: Radioligand 18F-AV-1451 (Device)

PTSD and TBI

Active Comparator

Volunteers with PTSD and mild traumatic brain injury

Intervention: MRI (Device)

PTSD and TBI

Active Comparator

Volunteers with PTSD and mild traumatic brain injury

Intervention: PET (Device)

PTSD and TBI

Active Comparator

Volunteers with PTSD and mild traumatic brain injury

Intervention: 18F-Florbetapir (Device)

PTSD and TBI

Active Comparator

Volunteers with PTSD and mild traumatic brain injury

Intervention: Radioligand 18F-AV-1451 (Device)

Outcomes

Primary Outcomes

Cortical thickness as measured by MRI scans

Time Frame: Baseline

Beta amyloid plaques as measured by PET scans

Time Frame: Baseline

Tau proteins as measured by PET scans

Time Frame: Baseline

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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