Back to resultsRisk Prediction for Alzheimer Dementia With Brain Imaging and Genetics
Primary Purpose
Alzheimer Dementia, Posttraumatic Stress Disorder, Traumatic Brain Injury
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MRI
PET
18F-Florbetapir
Radioligand 18F-AV-1451
Sponsored by
About this trial
This is an interventional basic science trial for Alzheimer Dementia focused on measuring Alzheimer Dementia, PTSD, MRI
Eligibility Criteria
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
Sites / Locations
- Durham VA
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
Healthy volunteers
Trauma only
PTSD only
PTSD and TBI
Arm Description
Volunteers with no trauma history
Volunteers that do not have PTSD but have had similar trauma to those with PTSD
Volunteers with PTSD but no traumatic brain injury
Volunteers with PTSD and mild traumatic brain injury
Outcomes
Primary Outcome Measures
Cortical thickness as measured by MRI scans
Beta amyloid plaques as measured by PET scans
Tau proteins as measured by PET scans
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03641768
Brief Title
Risk Prediction for Alzheimer Dementia With Brain Imaging and Genetics
Official Title
Risk Prediction for Alzheimer Dementia With Brain Imaging and Genetics
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Withdrawn
Why Stopped
Funding not received
Study Start Date
January 1, 2019 (Anticipated)
Primary Completion Date
January 1, 2021 (Anticipated)
Study Completion Date
January 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Dementia, Posttraumatic Stress Disorder, Traumatic Brain Injury
Keywords
Alzheimer Dementia, PTSD, MRI
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Healthy volunteers
Arm Type
Active Comparator
Arm Description
Volunteers with no trauma history
Arm Title
Trauma only
Arm Type
Active Comparator
Arm Description
Volunteers that do not have PTSD but have had similar trauma to those with PTSD
Arm Title
PTSD only
Arm Type
Active Comparator
Arm Description
Volunteers with PTSD but no traumatic brain injury
Arm Title
PTSD and TBI
Arm Type
Active Comparator
Arm Description
Volunteers with PTSD and mild traumatic brain injury
Intervention Type
Device
Intervention Name(s)
MRI
Intervention Description
You will be asked to undergo a scan of your brain called an MRI. The MRI scan can measure the functioning of your brain.
Intervention Type
Device
Intervention Name(s)
PET
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
18F-Florbetapir
Other Intervention Name(s)
PET tracer for Amyloid-beta
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Radioligand 18F-AV-1451
Other Intervention Name(s)
PET tracer for Tau protein
Intervention Description
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.
Primary Outcome Measure Information:
Title
Cortical thickness as measured by MRI scans
Time Frame
Baseline
Title
Beta amyloid plaques as measured by PET scans
Time Frame
Baseline
Title
Tau proteins as measured by PET scans
Time Frame
Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rajendra Morey, MD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Durham VA
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Risk Prediction for Alzheimer Dementia With Brain Imaging and Genetics
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