DOD-ADNI
Effects of Traumatic Brain Injury and Post Traumatic Stress Disorder on Alzheimer's Disease (AD) in Veterans Using Alzheimer's Disease Neuroimaging Initiative (ADNI)
Sponsor study identifier
Secondary identifiers
OTHER_GRANT · Department of Defense
OTHER_GRANT · Department of Defense
OTHER_GRANT · Department of Defense
observational
289
1 country
19
Study Start
October 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
September 21, 2021
Actual (reported)Study Completion
September 21, 2021
Actual (reported)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 (AD). The purpose of this study is to examine the possible connections between TBI and PTSD, and the signs and symptoms of AD on Veterans as they age. The information collected will help to learn more about how these injuries may affect Veterans of the Vietnam War as they grow older, as well as Veterans of the current wars in Iraq and Afghanistan, who also have these types of combat related injuries.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 21, 2021
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 31, 2012
Actual (reported)September 18, 2012
Actual (reported)October 2012
Date type not reportedThis date has not been verified as actual or estimated.
September 21, 2021
Actual (reported)September 21, 2021
Actual (reported)Rates of change in brain regions based on neuroimaging
Rates of change in brain regions based on neuroimaging (magnetic resonance imaging \[MRI\] and amyloid positron-emission tomography \[PET\]) to show that those with TBI and/or PTSD have increased evidence for AD compared to Veteran controls
1 year
Rates of change in CSF amyloid beta and CSF tau/P tau levels based on biomarkers
Rates of change in CSF amyloid beta and CSF tau/P tau levels based on biomarkers such as cerebrospinal fluid (CSF) to show that those with TBI and/or PTSD have increased evidence for AD compared to Veteran controls
1 year
Rates of change in neuropsychological measures of memory and general cognitive performance
Rates of change in neuropsychological measures of memory and general cognitive performance based on cognitive measures to show that those with TBI and/or PTSD have increased evidence for AD compared to Veteran controls
65-100 Vietnam Veterans with Traumatic Brain Injury (TBI), but without PTSD, mild cognitive impairment (MCI)/dementia
65-100 Vietnam Veterans with PTSD, but without TBI, MCI/dementia
65-100 Vietnam Veteran Controls without TBI or PTSD and comparable in age, gender, and education to the other cohorts
65-100 Vietnam Veterans with TBI but without PTSD who meet the criteria for MCI but not dementia
65-100 Vietnam Veterans with PTSD but without TBI who meet the criteria for MCI but not dementia
65-100 Vietnam Veteran Controls without TBI or PTSD who meet the criteria for MCI but not dementia, and are comparable in age, gender, and education to the other cohorts
Vietnam Veterans
Banner Sun Health Research Institute
Sun City, Arizona, 85351, United States
University of California, Irvine
Irvine, California, 92697, United States
University of California, San Diego
La Jolla, California, 92093, United States
University of Southern California
Los Angeles, California, 90033, United States
VA Palo Alto HSC / Stanford School of Medicine
Palo Alto, California, 94304, United States
University of California, San Francisco
San Francisco, California, 94117, United States
Georgetown University
Mueller SG, Weiner MW, Thal LJ, Petersen RC, Jack CR, Jagust W, Trojanowski JQ, Toga AW, Beckett L. Ways toward an early diagnosis in Alzheimer's disease: the Alzheimer's Disease Neuroimaging Initiative (ADNI). Alzheimers Dement. 2005 Jul;1(1):55-66. doi: 10.1016/j.jalz.2005.06.003.
Weiner MW, Aisen PS, Jack CR Jr, Jagust WJ, Trojanowski JQ, Shaw L, Saykin AJ, Morris JC, Cairns N, Beckett LA, Toga A, Green R, Walter S, Soares H, Snyder P, Siemers E, Potter W, Cole PE, Schmidt M; Alzheimer's Disease Neuroimaging Initiative. The Alzheimer's disease neuroimaging initiative: progress report and future plans. Alzheimers Dement. 2010 May;6(3):202-11.e7. doi: 10.1016/j.jalz.2010.03.007.
blood, urine, cerobrospinal fluid
Michael W. Weiner, MD
University of California, San Francisco
Paul Aisen, MD
USC Alzheimer's Therapeutic Research Institute (ATRI)
Ronald Petersen, MD, PhD
Mayo Clinic
289 participants (actual enrollment reported by the registry).
First Submitted
August 31, 2012
First Posted
September 18, 2012
Study Start
October 2012
Date type not reportedThis date has not been verified as actual or estimated.
1 Year
Correlations within each group (TBI and PTSD) to assess whether baseline levels or rates of atrophy or cognitive decline are associated with severity of TBI or PTSD
1 year
Group differences in the patterns of amyloid deposition (from Florbetapir F 18) and brain atrophy
1 year
Group differences in white matter integrity as assessed with Diffusion Tension Imaging (DTI)
1 year
Rate of change of tau deposition as measured by 18F-AV-1451
1 year
Contact the study team to confirm eligibility.
Washington D.C., District of Columbia, 20057, United States
Howard University
Washington D.C., District of Columbia, 20060, United States
Wien Center for Clinical Research
Miami Beach, Florida, 33140, United States
Premiere Research Institute
West Palm Beach, Florida, 33407, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Cornell Medical Center
New York, New York, 10021, United States
Columbia University
New York, New York, 10032, United States
University of Rochester Medical Center
Rochester, New York, 14620, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Roper St Francis Healthcare
Charleston, South Carolina, 29401, United States
U of WA / VA Puget Sound Alzheimer's Disease Research Center
Seattle, Washington, 98108, United States
University of Wisconsin
Madison, Wisconsin, 53705, United States
Jack CR Jr, Knopman DS, Jagust WJ, Shaw LM, Aisen PS, Weiner MW, Petersen RC, Trojanowski JQ. Hypothetical model of dynamic biomarkers of the Alzheimer's pathological cascade. Lancet Neurol. 2010 Jan;9(1):119-28. doi: 10.1016/S1474-4422(09)70299-6.
Vemuri P, Wiste HJ, Weigand SD, Shaw LM, Trojanowski JQ, Weiner MW, Knopman DS, Petersen RC, Jack CR Jr; Alzheimer's Disease Neuroimaging Initiative. MRI and CSF biomarkers in normal, MCI, and AD subjects: predicting future clinical change. Neurology. 2009 Jul 28;73(4):294-301. doi: 10.1212/WNL.0b013e3181af79fb.
Primary Completion
September 21, 2021
Actual (reported)Study Completion
September 21, 2021
Actual (reported)Last Updated
November 29, 2021
Record last verified: 2021-11
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: