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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT03641768
Other study ID # Pro00100030
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date January 1, 2019
Est. completion date January 1, 2021

Study information

Verified date October 2018
Source Duke University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date January 1, 2021
Est. primary completion date January 1, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Study Design


Intervention

Device:
MRI
You will be asked to undergo a scan of your brain called an MRI. The MRI scan can measure the functioning of your brain.
PET
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.
18F-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.
Radioligand 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.

Locations

Country Name City State
United States Durham VA Durham North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Cortical thickness as measured by MRI scans Baseline
Primary Beta amyloid plaques as measured by PET scans Baseline
Primary Tau proteins as measured by PET scans Baseline
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