CClinicalTrials.gg
WithdrawnNCT03641768Updated Oct 16, 2018

Risk Prediction for Alzheimer Dementia With Brain Imaging and Genetics

An interventional study of MRI and PET in Alzheimer Dementia, Posttraumatic Stress Disorder and Traumatic Brain Injury, sponsored by Duke University. Withdrawn at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-10-16.

Sponsored by Duke University · Not applicable, Interventional, and Basic science

Why this study was withdrawn
Funding not received
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Non-randomized
Ages
18 Years to 65 Years
Sex
All
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Study 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.

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Conditions studied

  • Alzheimer Dementia
  • Posttraumatic Stress Disorder
  • Traumatic Brain Injury

Keywords

  • Alzheimer Dementia
  • PTSD
  • MRI
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In context

Dementia

2,172 studies on the registry are indexed under Dementia; 541 are open to participants now.

Browse Dementia studies →

Lead sponsor

Duke University is the lead sponsor of 2,025 studies on the registry; 275 are open to participants now.

Of its 194 completed or terminated interventional studies of FDA-regulated products, 159 (82%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
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

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
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Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Active comparator
    Healthy volunteers

    Volunteers with no trauma history

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

  • Active comparator
    Trauma only

    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

  • Active comparator
    PTSD only

    Volunteers with PTSD but no traumatic brain injury

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

  • Active comparator
    PTSD and TBI

    Volunteers with PTSD and mild traumatic brain injury

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

Interventions

  • DeviceMRI

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

  • DevicePET

    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.

  • Device18F-Florbetapir

    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

  • DeviceRadioligand 18F-AV-1451

    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

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What researchers measure

Primary outcomes

  1. Cortical thickness as measured by MRI scans

    Time frame: Baseline

  2. Beta amyloid plaques as measured by PET scans

    Time frame: Baseline

  3. Tau proteins as measured by PET scans

    Time frame: Baseline

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Study locations

1 site
  • Durham VA
    Durham, North Carolina 27705, United States
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 16, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03641768
Lead sponsor
Duke University
Responsible party
Sponsor
First posted
Aug 22, 2018
Start date
Jan 1, 2019 (estimated)
Primary completion
Jan 1, 2021 (estimated)
Completion
Jan 1, 2021 (estimated)
Last update
Oct 16, 2018

Study contacts

Rajendra Morey, MD
principal investigator · Duke University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.

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