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Brain Aging in Vietnam War Veterans (DOD-ADNI)

Recruiting

Traumatic brain injury (TBI) and post traumatic stress disorder (PTSD) are common combat-related problems and may be associated with a greater risk of 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.

Minimum Age Maximum Age Gender Healthy Volunteers
50 Years 90 Years All Yes
October 2012
September 2020
420

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

All Participants

  • Mild cognitive impairment or dementia
  • History of psychosis or bipolar affective disorder
  • History of alcohol or substance abuse/dependence within the past 5 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, PET 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 5 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 5 minutes

Evidence suggests that TBI and PTSD, common problems resulting from military service, increase the risk of cognitive decline and Alzheimer's disease. To further assess this risk, researchers will compare brain changes over time in veterans with TBI or PTSD (with or without MCI) 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, a possible need for early detection of Alzheimer's in veterans with histories of TBI and PTSD, and a possible need to employ prevention and treatment measures to avoid accelerated development of Alzheimer's in this population.

This study is a first step toward a larger, more comprehensive study of dementia risk factors in veterans and design of a trial to prevent Alzheimer's.

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

Name City State Zip Status Primary Contact
Banner Sun Health Research Institute
Sun City Arizona 85351 Enrolling by invitation

University of California, Irvine
Irvine California 92697 Enrolling by invitation

University of California, San Diego
La Jolla California 92093 Enrolling by invitation

University of Southern California
Los Angeles California 90033 Enrolling by invitation

VA Palo Alto HSC / Stanford School of Medicine
Palo Alto California 94304 Enrolling by invitation

University of California, San Francisco
San Francisco California 94117 Recruiting Elise Ong
415-514-5753
elise.ong@ucsf.edu
Georgetown University
Washington District of Columbia 20057 Enrolling by invitation

Howard University
Washington District of Columbia 20060 Enrolling by invitation

Wien Center for Clinical Research
Miami Beach Florida 33140 Enrolling by invitation

Premiere Research Institute
West Palm Beach Florida 33407 Terminated

Rush University Medical Center
Chicago Illinois 60612 Enrolling by invitation

Brigham and Women's Hospital
Boston Massachusetts 02115 Enrolling by invitation

Cornell Medical Center
New York New York 10021 Terminated

Columbia University
New York New York 10032 Enrolling by invitation

University of Rochester Medical Center
Rochester New York 14620 Enrolling by invitation

Duke University Medical Center
Durham North Carolina 27710 Enrolling by invitation

Roper St Francis Healthcare
Charleston South Carolina 29401 Enrolling by invitation

U of WA / VA Puget Sound Alzheimer's Disease Research Center
Seattle Washington 98108 Enrolling by invitation

University of Wisconsin
Madison Wisconsin 53705 Enrolling by invitation

University of Southern California

  • 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

Name Role Affiliation
Michael W. Weiner, MD Study Director University of California, San Francisco
Paul Aisen, MD Principal Investigator USC Alzheimer's Therapeutic Research Institute (ATRI)
Ronald Petersen, MD, PhD Principal Investigator Mayo Clinic

Name Phone Email
Jacqueline Hayes 415-221-4810 x4593 jacqueline.hayes@va.gov

NCT01687153

Effects of Traumatic Brain Injury and Post Traumatic Stress Disorder on Alzheimer's Disease (AD) in Veterans Using Alzheimer's Disease Neuroimaging Initiative (ADNI)