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Brain Aging in Vietnam War Veterans (DOD-ADNI)

Start: October 2012
End: September 21, 2021
Enrollment: 600

What Is This Study About?

Evidence suggests that traumatic brain injury (TBI) and post-traumatic stress disorder (PTSD), common problems resulting from military service, increase the risk of cognitive decline and Alzheimer's disease. This study will examine the possible connections between TBI and PTSD, and the signs and symptoms of Alzheimer's in Vietnam War veterans as they age. Researchers will compare brain changes over time in veterans with TBI or PTSD (with or without mild cognitive impairment) to brain changes in cognitively normal veterans. Specifically, they will look for changes associated with Alzheimer's, including brain atrophy (shrinkage) and amyloid and tau levels in the brain and cerebrospinal fluid. All participants will undergo brain scans, lumbar puncture, and neuropsychological tests. The results will have major implications for identifying veterans at increased risk for Alzheimer's and a possible need for early detection of Alzheimer's in veterans with histories of TBI and PTSD.

Do I Qualify To Participate in This Study?

Minimum Age: 50 Years

Maximum Age: 90 Years

Must have:

All Participants

  • Veteran of the Vietnam War
  • Living within 150 miles of an Alzheimer's Disease Neuroimaging Initiative clinic

Cognitively Healthy Controls

  • Comparable in age, gender, and education with TBI and PTSD groups
  • May be receiving Veterans Affairs (VA) disability payments for something other than TBI or PTSD or have no disability at all

Participants with TBI

  • Documented history of moderate to severe, nonpenetrating TBI, which occurred during military service in Vietnam (identified from Department of Defense or VA records)
  • TBI will be defined as loss of consciousness with post-traumatic amnesia of more than 24 hours OR alteration of consciousness or mental state for more than 24 hours

Participants with PTSD

  • Current, chronic PTSD (identified by records and verified by our telephone assessments)
  • Current Clinician Administered PTSD Scale (CAPS) score of at least 50 as determined by telephone assessment
  • Both related to a Vietnam War-related trauma

Must NOT have:

All Participants

  • Mild cognitive impairment or dementia
  • History of psychosis or bipolar affective disorder
  • History of alcohol or substance abuse/dependence within the past five years or prior prolonged history of abuse
  • MRI-related exclusions: aneurysm clips, metal implants determined to be unsafe for MRI, and/or claustrophobia
  • Contraindications for lumbar puncture, positron emission tomography scan, or other procedures in this study
  • Any unstable major medical condition, including but not limited to clinically significant hepatic, renal, pulmonary, metabolic, or endocrine disease; cancer; HIV infection or AIDS; cardiovascular disease
  • Seizure disorder or any systemic illness affecting brain function during the past five years
  • Clinical evidence of stroke
  • History of relevant severe drug allergy or hypersensitivity
  • Current, clinically significant, unstable medical conditions that pose potential safety risk

Cognitively Healthy Controls

  • Exclusionary criteria applied to TBI and PTSD groups (see below)

Participants with TBI

  • Presence of PTSD or CAPS score of more than 30
  • History of PTSD

Participants with PTSD

  • Documented or self-report history of TBI
  • Any history of head trauma associated with injury, cognitive complaints, or loss of consciousness for more than five minutes

If I Qualify, Who Do I Contact?

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

 

Who Is the General Study Contact?

For more information about this trial, please contact Jacqueline Hayes at 415-221-4810 x4593 or jacqueline.hayes@va.gov.

Need Help?

Contact NIA’s Alzheimer’s and related Dementias Education and Referral (ADEAR) Center at 800-438-4380 or email ADEAR.

Where Is This Study Located?

Who Sponsors This Study?

Lead: University of Southern California

Collaborator Sponsor

  • United States Department of Defense
  • Telemedicine & Advanced Technology Research Center
  • Northern California Institute of Research and Education
  • San Francisco Veterans Affairs Medical Center
  • Alzheimer's Therapeutic Research Institute

Source: ClinicalTrials.gov ID: NCT01687153