Risk Prediction for Alzheimer Dementia With Brain Imaging and Genetics

NCT ID: NCT03641768

Last Updated: 2018-10-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-01

Study Completion Date

2021-01-01

Brief Summary

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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.

Detailed Description

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Conditions

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Alzheimer Dementia Posttraumatic Stress Disorder Traumatic Brain Injury

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Healthy volunteers

Volunteers with no trauma history

Group Type ACTIVE_COMPARATOR

MRI

Intervention Type DEVICE

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

Intervention Type DEVICE

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

Intervention Type DEVICE

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

Intervention Type DEVICE

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.

Trauma only

Volunteers that do not have PTSD but have had similar trauma to those with PTSD

Group Type ACTIVE_COMPARATOR

MRI

Intervention Type DEVICE

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

Intervention Type DEVICE

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

Intervention Type DEVICE

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

Intervention Type DEVICE

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.

PTSD only

Volunteers with PTSD but no traumatic brain injury

Group Type ACTIVE_COMPARATOR

MRI

Intervention Type DEVICE

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

Intervention Type DEVICE

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

Intervention Type DEVICE

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

Intervention Type DEVICE

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.

PTSD and TBI

Volunteers with PTSD and mild traumatic brain injury

Group Type ACTIVE_COMPARATOR

MRI

Intervention Type DEVICE

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

Intervention Type DEVICE

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

Intervention Type DEVICE

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

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

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.

Intervention Type DEVICE

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.

Intervention Type DEVICE

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.

Intervention Type DEVICE

Other Intervention Names

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PET tracer for Amyloid-beta PET tracer for Tau protein

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rajendra Morey, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

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Durham VA

Durham, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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Pro00100030

Identifier Type: -

Identifier Source: org_study_id

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