Traumatic Brain Injury and Dementia Risk in Veterans

What Is This Study About?

This study will examine whether veterans with a history of traumatic brain injury (TBI) have an elevated risk of developing dementia. Researchers will recruit veterans who are either healthy, have a history of TBI, or have mild cognitive impairment (MCI). In three study sessions, participants will undergo a neuropsychological assessment, MRI brain scans, provide blood and spinal fluid samples, and complete memory tests. Researchers will also measure participant brain activity as they complete a computer-based memory test. Over five years, researchers will continue to measure changes in memory, brain activity, and markers of neurodegeneration. The blood samples will be used for genetic testing for the APOE gene, associated with the risk of developing Alzheimer's disease.

Do I Qualify To Participate in This Study?

Must have:

All Participants:

• Able to speak English
• Right-handed
• At least 20/30 vision acuity with normal color vision
• Normal decision-making ability, based on study screening

Participants With Mild TBI:

• Diagnosis of one or more episodes of mild TBI episodes, with:
  • Loss of consciousness > 30 minutes, post-traumatic amnesia > 24 hours, and/or altered mental status > 24 hours
  • No moderate or severe TBI episodes

Participants With Moderate TBI:

• Diagnosis of one or more episodes of moderate TBI episodes, with:
  • Loss of consciousness > 30 minutes, post-traumatic amnesia > 24 hours, and/or altered mental status > 24 hours

Participants With MCI:

• Diagnosis of MCI, based on neuropsychological testing at study screening
• No history of TBI

Healthy Participants:

• Normal cognition, based on neuropsychological testing at study screening
• No history of TBI

Must NOT have:

• Diagnosis of any serious medical illness or condition that could interfere with the study, including:
  • TBI within one year of the study
  • Suicidal or homicidal ideation
  • Schizophrenia or bipolar disorder
  • Active alcohol or drug abuse
  • Serious neurological disease other than those mentioned in the inclusion criteria
• Women must not be pregnant
• Any condition or device that could make having an MRI brain scan unsafe (e.g., metal implants, shrapnel, aneurysm clips, pacemaker)
• Any condition that could make having a lumbar puncture unsafe, including:
  • Daily use of blood thinner medication (e.g., aspirin, clopidogrel)
  • Abnormal blood cell count
  • MRI brain scan showing abnormalities on spine
  • Infection or inflammation on spine

If I Qualify, Who Do I Contact?

Contact study personnel listed either under the general study contact or the location nearest you.

 

Where Is This Study Located?

Massachusetts
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA Boston, MA 02130 Recruiting Kristina Morreale, BA 857-364-2139 Kristina.Morreale@va.gov

Who Sponsors This Study?

Lead: VA Office of Research and Development

Collaborator Sponsor

• VA Boston Healthcare System

Source: ClinicalTrials.gov ID: NCT04124029