- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03641768
Risk Prediction for Alzheimer Dementia With Brain Imaging and Genetics
October 12, 2018 updated by: Duke University
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 Overview
Status
Withdrawn
Intervention / Treatment
Study Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
North Carolina
-
Durham, North Carolina, United States, 27705
- Durham VA
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Healthy volunteers
Volunteers with no trauma history
|
You will be asked to undergo a scan of your brain called an MRI.
The MRI scan can measure the functioning of your brain.
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.
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.
Other Names:
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.
Other Names:
|
Active Comparator: Trauma only
Volunteers that do not have PTSD but have had similar trauma to those with PTSD
|
You will be asked to undergo a scan of your brain called an MRI.
The MRI scan can measure the functioning of your brain.
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.
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.
Other Names:
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.
Other Names:
|
Active Comparator: PTSD only
Volunteers with PTSD but no traumatic brain injury
|
You will be asked to undergo a scan of your brain called an MRI.
The MRI scan can measure the functioning of your brain.
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.
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.
Other Names:
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.
Other Names:
|
Active Comparator: PTSD and TBI
Volunteers with PTSD and mild traumatic brain injury
|
You will be asked to undergo a scan of your brain called an MRI.
The MRI scan can measure the functioning of your brain.
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.
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.
Other Names:
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Cortical thickness as measured by MRI scans
Time Frame: Baseline
|
Baseline
|
Beta amyloid plaques as measured by PET scans
Time Frame: Baseline
|
Baseline
|
Tau proteins as measured by PET scans
Time Frame: Baseline
|
Baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Rajendra Morey, MD, Duke University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
January 1, 2019
Primary Completion (Anticipated)
January 1, 2021
Study Completion (Anticipated)
January 1, 2021
Study Registration Dates
First Submitted
August 20, 2018
First Submitted That Met QC Criteria
August 20, 2018
First Posted (Actual)
August 22, 2018
Study Record Updates
Last Update Posted (Actual)
October 16, 2018
Last Update Submitted That Met QC Criteria
October 12, 2018
Last Verified
October 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Wounds and Injuries
- Neurocognitive Disorders
- Neurodegenerative Diseases
- Craniocerebral Trauma
- Trauma, Nervous System
- Trauma and Stressor Related Disorders
- Tauopathies
- Stress Disorders, Traumatic
- Brain Injuries
- Stress Disorders, Post-Traumatic
- Dementia
- Brain Injuries, Traumatic
- Alzheimer Disease
Other Study ID Numbers
- Pro00100030
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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