Alzheimer DementiaNCT03641768
Risk Prediction for Alzheimer Dementia With Brain Imaging and Genetics
A study testing MRI, PET and 18F-Florbetapir in people with Alzheimer Dementia and Posttraumatic Stress Disorder, run by Duke University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Dementia, Posttraumatic Stress Disorder, Traumatic Brain Injury
- What is being tested?
- MRI, PET and 18F-Florbetapir
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2019to 1 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- MRI, PET, 18F-Florbetapir, Radioligand 18F-AV-1451
- Keywords
- Alzheimer Dementia, PTSD, MRI
- Medical subject headings
- Alzheimer Disease, Stress Disorders, Post-Traumatic, Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIDevice
You will be asked to undergo a scan of your brain called an MRI. The MRI scan can measure the functioning of your brain.
PETDevice
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-FlorbetapirDevice
Also called PET tracer for Amyloid-beta
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-1451Device
Also called PET tracer for Tau protein
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.
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteers | Active comparator | Volunteers with no trauma history Receives: Device: MRI; Device: PET; Device: 18F-Florbetapir; Device: Radioligand 18F-AV-1451 |
| Trauma only | Active comparator | Volunteers that do not have PTSD but have had similar trauma to those with PTSD Receives: Device: MRI; Device: PET; Device: 18F-Florbetapir; Device: Radioligand 18F-AV-1451 |
| PTSD only | Active comparator | Volunteers with PTSD but no traumatic brain injury Receives: Device: MRI; Device: PET; Device: 18F-Florbetapir; Device: Radioligand 18F-AV-1451 |
| PTSD and TBI | Active comparator | Volunteers with PTSD and mild traumatic brain injury Receives: Device: MRI; Device: PET; Device: 18F-Florbetapir; Device: Radioligand 18F-AV-1451 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cortical thickness as measured by MRI scans
Measured: Baseline
Beta amyloid plaques as measured by PET scans
Measured: Baseline
Tau proteins as measured by PET scans
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2018
- Study start1 Jan 2019 (estimated)
- Primary completion1 Jan 2021 (estimated)
- Study completion1 Jan 2021 (estimated)
Why it stopped: Funding not received
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DementiaStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rajendra Morey, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03641768
- Sponsor's protocol ID
- Pro00100030
- Status last verified
- Oct 2018
- First submitted
- 20 Aug 2018
- Last updated
- 16 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Prediction for Alzheimer Dementia With Brain Imaging and Genetics
- ClinicalTrials.gov ID
- NCT03641768
- Acronym / sponsor ID
- Pro00100030
- Keywords
- Alzheimer Dementia, PTSD, MRI
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding not received
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (estimated)
- Primary completion
- 1 Jan 2021 (estimated)
- Study completion
- 1 Jan 2021 (estimated)
- First posted
- 22 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers | Active comparator | Device: MRI, Device: PET, Device: 18F-Florbetapir, Device: Radioligand 18F-AV-1451Volunteers with no trauma history |
| Trauma only | Active comparator | Device: MRI, Device: PET, Device: 18F-Florbetapir, Device: Radioligand 18F-AV-1451Volunteers that do not have PTSD but have had similar trauma to those with PTSD |
| PTSD only | Active comparator | Device: MRI, Device: PET, Device: 18F-Florbetapir, Device: Radioligand 18F-AV-1451Volunteers with PTSD but no traumatic brain injury |
| PTSD and TBI | Active comparator | Device: MRI, Device: PET, Device: 18F-Florbetapir, Device: Radioligand 18F-AV-1451Volunteers with PTSD and mild traumatic brain injury |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRIYou will be asked to undergo a scan of your brain called an MRI. The MRI scan can measure the functioning of your brain. | Device | Healthy volunteers, PTSD and TBI, PTSD only, Trauma only |
| PETYou 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. | Device | Healthy volunteers, PTSD and TBI, PTSD only, Trauma only |
| 18F-FlorbetapirAlso: PET tracer for Amyloid-betaAt 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. | Device | Healthy volunteers, PTSD and TBI, PTSD only, Trauma only |
| Radioligand 18F-AV-1451Also: PET tracer for Tau proteinAt 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. | Device | Healthy volunteers, PTSD and TBI, PTSD only, Trauma only |
Primary outcome
Cortical thickness as measured by MRI scans
Time frame: Baseline
Beta amyloid plaques as measured by PET scans
Time frame: Baseline
Tau proteins as measured by PET scans
Time frame: Baseline
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2018.
- Individual participant dataSharing planned: No
Related trials for Alzheimer Dementia
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Not yet recruiting
Acupressure as Long-term Intervention to Slow the Progression of Early/Mild Alzheimer's Disease
Alzheimer's Disease
RecruitingObservational study
Effectiveness and Safety of Disease-Modifying Therapy for Alzheimer's Disease: A Multicenter Retrospective Study
Alzheimer's Disease (AD)
RecruitingPhase 3
A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-1)
Alzheimer Disease
RecruitingPhase 3
A Study of Trontinemab in Cognitively Unimpaired Individuals at Risk for Progression to Symptomatic Alzheimer's Disease
Alzheimer's Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rajendra Morey, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI, PET and 18F-Florbetapir in people with Alzheimer Dementia and Posttraumatic Stress Disorder, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 16 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cortical thickness as measured by MRI scans (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2018.