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NCT04124029Recruiting

Contributions of mTBI to Neurodegeneration Due to Chronic Traumatic Encephalopathy (CTE) and Alzheimer's Disease (AD)

Contributions of Mild Traumatic Brain Injury to Neurodegeneration Due to Chronic Traumatic Encephalopathy and Alzheimers Disease

Source: ClinicalTrials.gov · Last updated 1 Sept 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
800 (estimated)
First submitted
9 Oct 2019
Start date
1 Jul 2021
Primary completion date
31 Dec 2026
Lead sponsor
VA Office of Research and Development
NCT number
NCT04124029

What you commit to

  • Study type: Observational
  • Planned participants: 800
  • From 1 Jul 2021 to the primary completion date, 31 Dec 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Active alcohol or drug abuse
  • Implants

Other illness

  • Have a clinically significant problem with any of the following conditions:
  • A history of traumatic brain injury (TBI) within 1 year of study
  • Bipolar disorder
  • Clinically significant neurological disease other than those stated in the inclusion criteria

Other

  • All Subjects:
  • If the primary language is not English
  • Are unable to understand the informed consent process
  • Suicidal or homicidal ideation requiring intervention
  • Schizophrenia
  • Impaired decision-making ability
  • Patients will be excluded if there are contraindications to MRI including:
  • 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

Who the study is looking for

  • 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:
  • 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

Age in the registry: 30 years to 90 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Coordinator of this site? Confirm its status
BostonUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.