Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
289 participants
OBSERVATIONAL
2012-10-31
2021-09-21
Brief Summary
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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.
Detailed Description
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TBI and PTSD are common problems resulting from military service. Thus far, there have been no prospective studies using imaging and biomarkers, which directly measure changes in the brain and AD pathology to study the effects of TBI and PTSD. This proposed study will provide novel data to test these hypotheses. The results will have major implications for identifying, subjects at increased risk for AD, a possible need for early detection of AD in military Veterans with histories of TBI and PTSD, and a possible need to employ prevention and treatment measures to avoid accelerated development of AD in US military Veterans. This study is a first step toward a larger, more comprehensive study of dementia risk factors in Veterans. The results will lead to a design and statistical powering of a prevention trial. Therefore, this project could be the first step toward the prevention of AD in Veterans, and in the general population.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Traumatic Brain Injury (TBI)
65-100 Vietnam Veterans with Traumatic Brain Injury (TBI), but without PTSD, mild cognitive impairment (MCI)/dementia
No interventions assigned to this group
Post Traumatic Stress Disorder (PTSD)
65-100 Vietnam Veterans with PTSD, but without TBI, MCI/dementia
No interventions assigned to this group
Controls
65-100 Vietnam Veteran Controls without TBI or PTSD and comparable in age, gender, and education to the other cohorts
No interventions assigned to this group
TBI w/ MCI
65-100 Vietnam Veterans with TBI but without PTSD who meet the criteria for MCI but not dementia
No interventions assigned to this group
PTSD w/ MCI
65-100 Vietnam Veterans with PTSD but without TBI who meet the criteria for MCI but not dementia
No interventions assigned to this group
Controls w/ MCI
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
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Subjects must be Veterans of the Vietnam War, 50-90 years of age. (Subjects 60-80 years of age will be selected first, while subjects \<60 or \>80 years of age will be added if recruitment numbers are too low in the 60-80 age range);
* Must live within 150 miles of the closest ADNI clinic in subject's area.
* 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 no disability at all.
* Subjects must have a documented history of moderate-severe non-penetrating TBI, which occurred during military service in Vietnam (identified from the Department of Defense or VA records);
* TBI will be defined as:
* Loss of consciousness,
* Post-traumatic amnesia \>24 hours, OR
* Alteration of consciousness or mental state \>24 hours
* Subjects who meet the Structured Clinical Interview 1 of the Diagnositic and Statistical Manual of Mental Disorders, Version IV, (Axis 1) - Text Revision \[SCID-I of the DSM-IV-TR\] criteria for current/chronic PTSD (identified by records, and verified by our telephone assessments);
* In addition to meeting DSM-IV-TR criteria for current/chronic PTSD, subjects must have a minimum current Clinician Administered PTSD Scale (CAPS) score of 50 as determined by telephone assessment;
* The PTSD symptoms contributing to the PTSD Diagnosis and Current CAPS score must be related to a Vietnam War related trauma.
Exclusion Criteria
* MCI/dementia;
* History of psychosis or bipolar affective disorder;
* History of alcohol or substance abuse/dependence within the past 5 years (by DSM-IV-TR criteria) or a prior prolonged history of abuse;
* MRI-related exclusions: aneurysm clips, metal implants that are determined to be unsafe for MRI; and/or claustrophobia;
* Contraindications for lumbar puncture, PET scan, or other procedures in this study;
* Any major medical condition must be stable for at least 4 months prior to enrollment. These include but are not limited to clinically significant hepatic, renal, pulmonary, metabolic or endocrine disease, cancer, HIV infection and AIDS, as well as cardiovascular disease, including:
* cardiac surgery or myocardial infarction within the last 4 weeks;
* unstable angina;
* acute decompensated congestive heart failure or class IV heart failures;
* current significant cardiac arrhythmia or conduction disturbance particularly those resulting in ventricular fibrillation, or causing syncope, or near syncope;
* Uncontrolled high blood pressure
* Seizure disorder or any systemic illness affecting brain function during the past 5 years will be exclusionary;
* Clinical evidence of stroke;
* Have a history of relevant severe drug allergy or hypersensitivity;
* Subjects with current clinically significant unstable medical comorbidities, as indicated by history or physical exam, that pose a potential safety risk to the subject.
• Exclusionary criteria applied to TBI/PTSD (outlined below) will be applied to controls.
• Presence of PTSD by SCID-I for DSM-IV-TR criteria, or a CAPS score of \>30 (Both current and/or a history of PTSD will be excluded).
* Documented or self report history of mild/moderate severe TBI;
* Any history of head trauma associated with injury onset cognitive complaints; or
* Loss of consciousness for \>5 minutes.
50 Years
90 Years
ALL
Yes
Sponsors
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United States Department of Defense
FED
Telemedicine & Advanced Technology Research Center
OTHER
Northern California Institute of Research and Education
OTHER
San Francisco Veterans Affairs Medical Center
FED
Alzheimer's Therapeutic Research Institute
OTHER
University of Southern California
OTHER
Responsible Party
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Paul Aisen
Professor
Principal Investigators
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Michael W. Weiner, MD
Role: STUDY_DIRECTOR
University of California, San Francisco
Paul Aisen, MD
Role: PRINCIPAL_INVESTIGATOR
USC Alzheimer's Therapeutic Research Institute (ATRI)
Ronald Petersen, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Banner Sun Health Research Institute
Sun City, Arizona, United States
University of California, Irvine
Irvine, California, United States
University of California, San Diego
La Jolla, California, United States
University of Southern California
Los Angeles, California, United States
VA Palo Alto HSC / Stanford School of Medicine
Palo Alto, California, United States
University of California, San Francisco
San Francisco, California, United States
Georgetown University
Washington D.C., District of Columbia, United States
Howard University
Washington D.C., District of Columbia, United States
Wien Center for Clinical Research
Miami Beach, Florida, United States
Premiere Research Institute
West Palm Beach, Florida, United States
Rush University Medical Center
Chicago, Illinois, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Cornell Medical Center
New York, New York, United States
Columbia University
New York, New York, United States
University of Rochester Medical Center
Rochester, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Roper St Francis Healthcare
Charleston, South Carolina, United States
U of WA / VA Puget Sound Alzheimer's Disease Research Center
Seattle, Washington, United States
University of Wisconsin
Madison, Wisconsin, United States
Countries
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References
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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.
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.
Related Links
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Alzheimer's Disease Neuroimaging Initiative (ADNI)
U.S. Department of Veterans Affairs
Laboratory of Neuro Imaging (LONI)
Alzheimer's Therapeutic Research Institute
Other Identifiers
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W81XWH-12-2-0012
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
W81XWH-13-1-0259
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
W81XWH-14-1-0462
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
ADC-044
Identifier Type: -
Identifier Source: org_study_id