Actively Recruiting
Contributions of mTBI to Neurodegeneration Due to Chronic Traumatic Encephalopathy (CTE) and Alzheimer's Disease (AD)
Led by VA Office of Research and Development · Updated on 2025-09-26
800
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
Sponsors
V
VA Office of Research and Development
Lead Sponsor
V
VA Boston Healthcare System
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Contributions of mTBI to Neurodegeneration Due to Chronic Traumatic Encephalopathy (CTE) and Alzheimer's Disease (AD)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
- No contraindications to lumbar puncture including being on blood thinners like aspirin or Plavix
- No space occupying lesion on MRI
- INR value less than 1.4 and platelet count above 50,000
- No epidural infection or cellulitis over lumbar spine
- PTSD presence will be considered as a covariate in analyses
- Mild TBI subjects must have physician diagnosis of one or more mild TBI episodes without moderate or severe TBI diagnosis
- Mild TBI defined by loss of consciousness less than 30 minutes, posttraumatic amnesia less than 24 hours, and/or altered mental status less than 24 hours
- Moderate TBI subjects must have physician diagnosis of one or more moderate TBI episodes
- Moderate TBI defined by loss of consciousness greater than 30 minutes, posttraumatic amnesia greater than 24 hours, and altered mental status greater than 24 hours
- MCI subjects must meet diagnostic criteria for mild cognitive impairment without history of TBI
- MCI subjects must test impaired on one or more cognitive domains but have no functional impairments
- MCI subjects may or may not meet criteria for MCI due to Alzheimer's disease
- MCI subjects matched for MoCA score with older TBI subjects
- Healthy controls must be cognitively normal, age, education, and sex matched with mild TBI subjects
- All subjects must be within 1 standard deviation of normal on neuropsychological testing
You will not qualify if you...
- Primary language not English
- Unable to understand informed consent process
- History of TBI within 1 year of study
- Suicidal or homicidal ideation requiring intervention
- Schizophrenia
- Bipolar disorder
- Active alcohol or drug abuse
- Clinically significant neurological disease other than those stated in inclusion criteria
- Impaired decision-making ability
- Contraindications to MRI including implants, shrapnel, aneurysm clips, pacemaker, or pregnancy
- Non-TBI subjects must not have had a TBI
- Contraindications to lumbar puncture or blood draw including being on blood thinners like aspirin or Plavix
- Presence of space occupying lesion on MRI making lumbar puncture contraindicated
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Boston, Massachusetts, United States, 02130-4817
Actively Recruiting
Research Team
K
Kristina Morreale, BA
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
6
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