Risk Prediction for Alzheimer Dementia With Brain Imaging and Genetics

Traumatic Brain Injury Clinical Trial

Official title:

Risk Prediction for Alzheimer Dementia With Brain Imaging and Genetics

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03641768
• Other study ID #: Pro00100030
• Status: Withdrawn
• Phase: N/A
• 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
• 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• Status: Withdrawn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

Related Conditions & MeSH terms

• Alzheimer Dementia
• Alzheimer Disease
• Brain Injuries
• Brain Injuries, Traumatic
• Dementia
• Posttraumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Traumatic Brain Injury

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