Mild Traumatic Brain InjuryNCT04124029
Contributions of mTBI to Neurodegeneration Due to Chronic Traumatic Encephalopathy (CTE) and Alzheimer's Disease (AD)
An observational study of Mild Traumatic Brain Injury and Moderate Traumatic Brain Injury, run by VA Office of Research and Development at 1 site in United States.
Trial summary
This is a research study that aims to examine whether Veterans with mild Traumatic Brain Injuries are at risk for dementia by studying their memory, brain wave activity, brain structure and proteins that can be elevated after brain injury and in dementia. Read more about this study
- Who is it for?
- Ages 30 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Mild Traumatic Brain Injury, Moderate Traumatic Brain Injury, Mild Cognitive Impairment
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 800 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2021to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 30 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients from the memory disorders clinic will be recruited if they have a (1) history of mild TBI, (2) history of moderate TBI, or (3) mild cognitive impairment. In addition, the investigators will be recruiting healthy controls that meet satisfy the inclusion and exclusion criteria of the study.
Who may be able to join
- All Subjects:
- Intact color vision
- Visual acuity of 20/30 (or better)
- Patients must pass effort measures on the TOMM
- Patients must have intact decision-making capacity
- Patients must have no contraindications to lumbar puncture including:
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- Being on a blood thinner
- Aspirin or Plavix
- Have no space occupying lesion on magnetic resonance imaging (MRI)
- An International Normalized Ratio (INR) value < 1.4 and platelet count >50,000
- No epidural infection or overlying cellulitis over the lumbar spine
- PTSD will be accounted for as a potential confounder and its presence will be included as a covariate in all analyses
- Mild traumatic brain injury (TBI) Subjects:
- Subjects will be recruited who have a physician diagnosis of 1 or more mTBI episodes without concomitant moderate or severe TBI diagnosis
- Mild TBI: Loss of consciousness greater than 30 minutes, posttraumatic amnesia greater than 24 hours, and/or altered mental status greater than 24 hours
- Moderate TBI Subjects:
- Subjects will be recruited who have a physician diagnosis of 1 or more moderate TBI episodes
- Moderate TBI: loss of consciousness greater than 30 minutes, posttraumatic amnesia greater than 24 hours, and altered mental status greater than 24 hours
- Mild Cognitive Impairment (MCI) Subjects:
- Subjects will be recruited that meet diagnostic criteria for MCI (without a history of TBI) based on the judgement of a behavioral neurologist following the 2011 MCI criteria
- Specifically, subjects will test in the impaired range on one or more cognitive domains on neuropsychological testing and will not have impairments in function, i.e. will not meet diagnostic criteria for dementia
- Subjects with MCI may or may not meet diagnostic criteria for MCI due to AD
- MCI subjects will be matched for their MoCA score with older TBI subjects
- Healthy Controls:
- Cognitively normal control subjects, age-, education- and sex-matched with mild TBI subjects, but lacking and TBI history
- All subjects must be within 1 standard deviation of normal on all neuropsychologic testing in order to be enrolled
- The investigators will recruit all subjects without regard to gender, race, ethnicity, socioeconomic status, or other factors to allow results of this research to yield the greatest generalizability
Who cannot join
- All Subjects:
- If the primary language is not English
- Are unable to understand the informed consent process
- Have a clinically significant problem with any of the following conditions:
- A history of traumatic brain injury (TBI) within 1 year of study
- Suicidal or homicidal ideation requiring intervention
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- Schizophrenia
- Bipolar disorder
- Active alcohol or drug abuse
- Clinically significant neurological disease other than those stated in the inclusion criteria
- Impaired decision-making ability
- Patients will be excluded if there are contraindications to MRI including:
- Implants
- Shrapnel
- Aneurysm clips
- Pacemaker
- Pregnancy
- Non-TBI subjects must not have had an TBI
- No contraindication to lumbar puncture or blood draw including:
- Being on a blood thinner
- Aspirin or Plavix
- No space occupying lesion on MRI that makes lumbar puncture contraindicated
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Boston, Massachusetts, 02130-4817
Kristina Morreale, BA, (857) 364-2139 ext. 4554, Kristina.Morreale@va.gov
Katherine Turk, MD
About this study
Official title: Contributions of Mild Traumatic Brain Injury to Neurodegeneration Due to Chronic Traumatic Encephalopathy and Alzheimers Disease
This is a research study that aims to examine whether Veterans with mild Traumatic Brain Injuries are at risk for dementia by studying their memory, brain wave activity, brain structure and proteins that can be elevated after brain injury and in dementia.
Read the detailed description
The specific aim of this project is to examine whether Veterans with mild Traumatic Brain Injuries are at risk for dementia by studying their memory, brain wave activity, brain structure and proteins that can be elevated after brain injury and in dementia.
This study will recruit patients with a history of mild-moderate traumatic brain injury, mild cognitive impairment, as well as healthy controls in order to better understand how single or repetitive mild Traumatic brain injuries may contribute to the development of dementia. It will be prospective in nature. Participants will be asked to complete a series of 3 study sessions. During the first study session, each subject will be asked to complete a neuropsychological assessment. If the subject's testing scores fall under the study criteria, they will also be asked to complete a computer task. In the second study session, the investigators will measure the subjects brain waves using an electroencephalogram (EEG) while they complete a computer task. During the computer task, subjects will be asked to study a list of words and the investigators will test the subjects on their memory for those words. During the final study session, the investigators will ask subjects to complete (1) an MRI scan, (2) a standard blood draw procedure, and (3) a lumbar puncture procedure.
Clinical Implications: These studies will provide a better understanding of which individuals with Traumatic Brain Injury will develop dementia, and how many years in the future dementia may occur.
- Being tested
- No Intervention is used for this study but all subjects will be asked to complete electroencephalogram (EEG) testing and an MRI scan., No intervention is used for this study but all subjects will be asked to complete a venous blood draw procedure and a lumbar puncture procedure.
- Keywords
- Mild Traumatic Brain Injury, Moderate Traumatic Brain Injury, Alzheimer's Disease, Chronic Traumatic Encephalopathy, Neurodegeneration
- Medical subject headings
- Brain Concussion, Cognitive Dysfunction, Alzheimer Disease, Chronic Traumatic Encephalopathy, Nerve Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Intervention is used for this study but all subjects will be asked to complete electroencephalogram (EEG) testing and an MRI scan.Device
No intervention will be used.
No intervention is used for this study but all subjects will be asked to complete a venous blood draw procedure and a lumbar puncture procedure.Procedure or surgery
No intervention will be used.
| Study group | Role | What they receive |
|---|---|---|
| Younger mild Traumatic Brain Injury | mTBI subjects aged 30-59 yo will be recruited who have a physician diagnosis of 1 or more mTBI episodes without concomitant moderate or severe TBI diagnosis (loss of consciousness greater than 30 minutes, posttraumatic amnesia greater than 24 hours, or altered mental status greater than 24 hours). mTBI subjects must pass effort measures on the Test of Memory Malingering (TOMM) and have intact color vision and visual acuity of 20/30 or better in order to be included in the study. Receives: Device: No Intervention is used for this study but all subjects will be asked to complete electroencephalogram (EEG) testing and an MRI scan.; Procedure: No intervention is used for this study but all subjects will be asked to complete a venous blood draw procedure and a lumbar puncture procedure. | |
| Older mild Traumatic Brain Injury | mTBI subjects aged 60- 90 yo will be recruited who have a physician diagnosis of 1 or more mTBI episodes without concomitant moderate or severe TBI diagnosis (loss of consciousness greater than 30 minutes, posttraumatic amnesia greater than 24 hours, or altered mental status greater than 24 hours). mTBI subjects must pass effort measures on the TOMM and have intact color vision and visual acuity of 20/30 or better in order to be included in the study. Receives: Device: No Intervention is used for this study but all subjects will be asked to complete electroencephalogram (EEG) testing and an MRI scan.; Procedure: No intervention is used for this study but all subjects will be asked to complete a venous blood draw procedure and a lumbar puncture procedure. | |
| moderate Traumatic Brain Injury | TBI control subjects, age-, education- and sex-matched with mTBI subjects (aged 30-90) will be recruited who have a physician diagnosis of 1 or more moderate TBI episodes (loss of consciousness greater than 30 minutes, posttraumatic amnesia greater than 24 hours, or altered mental status greater than 24 hours). Moderate TBI subjects must pass effort measures on the TOMM and have intact color vision and visual acuity of 20/30 or better in order to be included in the study. Receives: Device: No Intervention is used for this study but all subjects will be asked to complete electroencephalogram (EEG) testing and an MRI scan.; Procedure: No intervention is used for this study but all subjects will be asked to complete a venous blood draw procedure and a lumbar puncture procedure. | |
| Mild Cognitive Impairment (MCI) | MCI control subjects, age-, education- and sex-matched with older mTBI subjects (aged 60-90) will be recruited if they meet diagnostic criteria for MCI (without a history of TBI) based on the judgement of a behavioral neurologist following the 2011 MCI criteria. Specifically, subjects will test in the impaired range on one or more cognitive domains on neuropsychological testing and will not have impairments in function (i.e. will not meet diagnostic criteria for dementia). MCI subjects will be matched for their Montreal Cognitive Assessment (MoCA) score with older mTBI subjects. Of note, subjects with MCI may or may not meet diagnostic criteria for MCI due to AD. The intent of this control group is to recruit a broad range of MCI subjects without TBI as controls for subjects with cognitive impairment who have a history of mTBI. Receives: Device: No Intervention is used for this study but all subjects will be asked to complete electroencephalogram (EEG) testing and an MRI scan.; Procedure: No intervention is used for this study but all subjects will be asked to complete a venous blood draw procedure and a lumbar puncture procedure. | |
| Younger Healthy Controls | Cognitively normal control subjects, age-, education- and sex-matched with younger mTBI subjects, but lacking and mTBI history. All subjects must be within 1 standard deviation of normal on all neuropsychologic testing in order to be enrolled. Receives: Device: No Intervention is used for this study but all subjects will be asked to complete electroencephalogram (EEG) testing and an MRI scan.; Procedure: No intervention is used for this study but all subjects will be asked to complete a venous blood draw procedure and a lumbar puncture procedure. | |
| Older Healthy Controls | Cognitively normal control subjects, age-, education- and sex-matched with older mTBI subjects, but lacking and mTBI history. All subjects must be within 1 standard deviation of normal on all neuropsychologic testing in order to be enrolled. Receives: Device: No Intervention is used for this study but all subjects will be asked to complete electroencephalogram (EEG) testing and an MRI scan.; Procedure: No intervention is used for this study but all subjects will be asked to complete a venous blood draw procedure and a lumbar puncture procedure. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To better understand the contribution of mild Traumatic Brain Injury (mTBI) to neurodegeneration with the intent of detecting early behavioral, physiologic, anatomic, and protein evidence of neurodegeneration due to AD and CTE
The work proposed will allow exploration of the relationships between behavioral, event-related potential (ERP), MRI, and cerebrospinal fluid (CSF) measures at a variety of points along the disease continuum and will allow for future longitudinal studies in this cohort
Measured: 5 years
Secondary outcomes (4)
Recognition Memory
Recognition memory will be examined using behavioral estimation techniques to see if recognition memory will be worse in patients with an increased number of mild TBI and with increased time since mild TBI.
Measured: 5 Years
Electroencephalogram (EEG) peak amplitude and latency
The investigators are trying to see if electrophysiological correlates of recollection will be decreased in patients with a greater number of mTBI episodes and those with increased time since mTBI episodes; and if the electrophysiological correlates of familiarity will be decreased in patients with dementia who have imaging and cerebrospinal fluid (CSF) biomarkers consistent with neurodegeneration.
Measured: 5 years
Cortical, quantitative MRI volume measurements
The investigators are trying to see if global cortical atrophy, hippocampal and extrahippocampal medial temporal lobe (MTL) atrophy will be increased in patients with a greater number of mTBI episodes and those with increased time since mTBI episodes.
Measured: 5 years
CSF Proteinopathy
The investigators are trying to see if a cerebrospinal fluid (CSF) proteinopathy will be present in patients with a greater number of mTBI episodes and those with increased time since mTBI episodes.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2019
- Study start1 Jul 2021
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- VA Boston Healthcare System
- Responsible party
- Sponsor
- Investigators
- Katherine Turk, MD, Principal investigator, VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04124029
- Sponsor's protocol ID
- NURD-011-19F
- Other IDs
- I01-CX-19-008-CDA
- Status last verified
- Aug 2026
- First submitted
- 9 Oct 2019
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data will be shared with other investigators upon written request.
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contributions of Mild Traumatic Brain Injury to Neurodegeneration Due to Chronic Traumatic Encephalopathy and Alzheimers Disease
- ClinicalTrials.gov ID
- NCT04124029
- Acronym / sponsor ID
- NURD-011-19F
- Keywords
- Mild Traumatic Brain Injury, Moderate Traumatic Brain Injury, Alzheimer's Disease, Chronic Traumatic Encephalopathy, Neurodegeneration
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- VA Boston Healthcare System
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 11 Oct 2019 (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.
This is a research study that aims to examine whether Veterans with mild Traumatic Brain Injuries are at risk for dementia by studying their memory, brain wave activity, brain structure and proteins that can be elevated after brain injury and in dementia.
Detailed description
The specific aim of this project is to examine whether Veterans with mild Traumatic Brain Injuries are at risk for dementia by studying their memory, brain wave activity, brain structure and proteins that can be elevated after brain injury and in dementia.
This study will recruit patients with a history of mild-moderate traumatic brain injury, mild cognitive impairment, as well as healthy controls in order to better understand how single or repetitive mild Traumatic brain injuries may contribute to the development of dementia. It will be prospective in nature. Participants will be asked to complete a series of 3 study sessions. During the first study session, each subject will be asked to complete a neuropsychological assessment. If the subject's testing scores fall under the study criteria, they will also be asked to complete a computer task. In the second study session, the investigators will measure the subjects brain waves using an electroencephalogram (EEG) while they complete a computer task. During the computer task, subjects will be asked to study a list of words and the investigators will test the subjects on their memory for those words. During the final study session, the investigators will ask subjects to complete (1) an MRI scan, (2) a standard blood draw procedure, and (3) a lumbar puncture procedure.
Clinical Implications: These studies will provide a better understanding of which individuals with Traumatic Brain Injury will develop dementia, and how many years in the future dementia may occur.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Younger mild Traumatic Brain Injury | – | Device: No Intervention is used for this study but all subjects will be asked to complete electroencephalogram (EEG) testing and an MRI scan., Procedure: No intervention is used for this study but all subjects will be asked to complete a venous blood draw procedure and a lumbar puncture procedure.mTBI subjects aged 30-59 yo will be recruited who have a physician diagnosis of 1 or more mTBI episodes without concomitant moderate or severe TBI diagnosis (loss of consciousness greater than 30 minutes, posttraumatic amnesia greater than 24 hours, or altered mental status greater than 24 hours). mTBI subjects must pass effort measures on the Test of Memory Malingering (TOMM) and have intact color vision and visual acuity of 20/30 or better in order to be included in the study. |
| Older mild Traumatic Brain Injury | – | Device: No Intervention is used for this study but all subjects will be asked to complete electroencephalogram (EEG) testing and an MRI scan., Procedure: No intervention is used for this study but all subjects will be asked to complete a venous blood draw procedure and a lumbar puncture procedure.mTBI subjects aged 60- 90 yo will be recruited who have a physician diagnosis of 1 or more mTBI episodes without concomitant moderate or severe TBI diagnosis (loss of consciousness greater than 30 minutes, posttraumatic amnesia greater than 24 hours, or altered mental status greater than 24 hours). mTBI subjects must pass effort measures on the TOMM and have intact color vision and visual acuity of 20/30 or better in order to be included in the study. |
| moderate Traumatic Brain Injury | – | Device: No Intervention is used for this study but all subjects will be asked to complete electroencephalogram (EEG) testing and an MRI scan., Procedure: No intervention is used for this study but all subjects will be asked to complete a venous blood draw procedure and a lumbar puncture procedure.TBI control subjects, age-, education- and sex-matched with mTBI subjects (aged 30-90) will be recruited who have a physician diagnosis of 1 or more moderate TBI episodes (loss of consciousness greater than 30 minutes, posttraumatic amnesia greater than 24 hours, or altered mental status greater than 24 hours). Moderate TBI subjects must pass effort measures on the TOMM and have intact color vision and visual acuity of 20/30 or better in order to be included in the study. |
| Mild Cognitive Impairment (MCI) | – | Device: No Intervention is used for this study but all subjects will be asked to complete electroencephalogram (EEG) testing and an MRI scan., Procedure: No intervention is used for this study but all subjects will be asked to complete a venous blood draw procedure and a lumbar puncture procedure.MCI control subjects, age-, education- and sex-matched with older mTBI subjects (aged 60-90) will be recruited if they meet diagnostic criteria for MCI (without a history of TBI) based on the judgement of a behavioral neurologist following the 2011 MCI criteria. Specifically, subjects will test in the impaired range on one or more cognitive domains on neuropsychological testing and will not have impairments in function (i.e. will not meet diagnostic criteria for dementia). MCI subjects will be matched for their Montreal Cognitive Assessment (MoCA) score with older mTBI subjects. Of note, subjects with MCI may or may not meet diagnostic criteria for MCI due to AD. The intent of this control group is to recruit a broad range of MCI subjects without TBI as controls for subjects with cognitive impairment who have a history of mTBI. |
| Younger Healthy Controls | – | Device: No Intervention is used for this study but all subjects will be asked to complete electroencephalogram (EEG) testing and an MRI scan., Procedure: No intervention is used for this study but all subjects will be asked to complete a venous blood draw procedure and a lumbar puncture procedure.Cognitively normal control subjects, age-, education- and sex-matched with younger mTBI subjects, but lacking and mTBI history. All subjects must be within 1 standard deviation of normal on all neuropsychologic testing in order to be enrolled. |
| Older Healthy Controls | – | Device: No Intervention is used for this study but all subjects will be asked to complete electroencephalogram (EEG) testing and an MRI scan., Procedure: No intervention is used for this study but all subjects will be asked to complete a venous blood draw procedure and a lumbar puncture procedure.Cognitively normal control subjects, age-, education- and sex-matched with older mTBI subjects, but lacking and mTBI history. All subjects must be within 1 standard deviation of normal on all neuropsychologic testing in order to be enrolled. |
Who may qualify
- Ages
- 30 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients from the memory disorders clinic will be recruited if they have a (1) history of mild TBI, (2) history of moderate TBI, or (3) mild cognitive impairment. In addition, the investigators will be recruiting healthy controls that meet satisfy the inclusion and exclusion criteria of the study.
Key inclusion criteria (27 listed)
- Intact color vision
- Visual acuity of 20/30 (or better)
- Patients must pass effort measures on the TOMM
- Patients must have intact decision-making capacity
- Patients must have no contraindications to lumbar puncture including:
Key exclusion criteria (22 listed)
- If the primary language is not English
- Are unable to understand the informed consent process
- Have a clinically significant problem with any of the following conditions:
- A history of traumatic brain injury (TBI) within 1 year of study
- Suicidal or homicidal ideation requiring intervention
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 |
|---|---|---|
| No Intervention is used for this study but all subjects will be asked to complete electroencephalogram (EEG) testing and an MRI scan.No intervention will be used. | Device | Mild Cognitive Impairment (MCI), Older Healthy Controls, Older mild Traumatic Brain Injury, Younger Healthy Controls, Younger mild Traumatic Brain Injury, moderate Traumatic Brain Injury |
| No intervention is used for this study but all subjects will be asked to complete a venous blood draw procedure and a lumbar puncture procedure.No intervention will be used. | Procedure or surgery | Mild Cognitive Impairment (MCI), Older Healthy Controls, Older mild Traumatic Brain Injury, Younger Healthy Controls, Younger mild Traumatic Brain Injury, moderate Traumatic Brain Injury |
Primary outcome
To better understand the contribution of mild Traumatic Brain Injury (mTBI) to neurodegeneration with the intent of detecting early behavioral, physiologic, anatomic, and protein evidence of neurodegeneration due to AD and CTE
Time frame: 5 years
The work proposed will allow exploration of the relationships between behavioral, event-related potential (ERP), MRI, and cerebrospinal fluid (CSF) measures at a variety of points along the disease continuum and will allow for future longitudinal studies in this cohort
4 secondary outcomes
Recognition Memory
Time frame: 5 Years
Electroencephalogram (EEG) peak amplitude and latency
Time frame: 5 years
Cortical, quantitative MRI volume measurements
Time frame: 5 years
CSF Proteinopathy
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- Individual participant dataSharing planned: Yes. De-identified data will be shared with other investigators upon written request.
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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.
Katherine Turk, MD principal investigator
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mild Traumatic Brain Injury and Moderate Traumatic Brain Injury, run by VA Office of Research and Development 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 27 inclusion and 22 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: looking for participants now, as of the sponsor's last update on 1 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kristina Morreale, BA ((857) 364-2139 ext. 4554, Kristina.Morreale@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To better understand the contribution of mild Traumatic Brain Injury (mTBI) to neurodegeneration with the intent of detecting early behavioral, physiologic, anatomic, and protein evidence of neurodegeneration due to AD and CTE (time frame: 5 years). 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 1 Sep 2026.