A Study of Brain Aging in Vietnam War Veterans (DOD-ADNI)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01687153|
Recruitment Status : Completed
First Posted : September 18, 2012
Last Update Posted : November 29, 2021
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.
|Condition or disease|
|Traumatic Brain Injury Post Traumatic Stress Disorder Alzheimer's Disease Mild Cognitive Impairment|
The overall long-term goal of this project is to prevent AD, which affects almost 50% of the US population over 85 years of age, and is the most common cause of dementia. Clinical signs and symptoms of AD include cognitive impairments, especially memory and emotional disturbances. In order to accomplish this goal of prevention, a population at risk must be identified. Evidence suggests that both TBI and PTSD increase risk for cognitive decline, AD, and dementia.
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.
|Study Type :||Observational|
|Actual Enrollment :||289 participants|
|Official Title:||Effects of Traumatic Brain Injury and Post Traumatic Stress Disorder on Alzheimer's Disease (AD) in Veterans Using Alzheimer's Disease Neuroimaging Initiative (ADNI)|
|Study Start Date :||October 2012|
|Actual Primary Completion Date :||September 21, 2021|
|Actual Study Completion Date :||September 21, 2021|
Traumatic Brain Injury (TBI)
65-100 Vietnam Veterans with Traumatic Brain Injury (TBI), but without PTSD, mild cognitive impairment (MCI)/dementia
Post Traumatic Stress Disorder (PTSD)
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
TBI w/ MCI
65-100 Vietnam Veterans with TBI but without PTSD who meet the criteria for MCI but not dementia
PTSD w/ MCI
65-100 Vietnam Veterans with PTSD but without TBI who meet the criteria for MCI but not dementia
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
- Rates of change in brain regions based on neuroimaging [ Time Frame: 1 year ]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
- Rates of change in CSF amyloid beta and CSF tau/P tau levels based on biomarkers [ Time Frame: 1 year ]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
- Rates of change in neuropsychological measures of memory and general cognitive performance [ Time Frame: 1 Year ]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
- 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 [ Time Frame: 1 year ]
- Group differences in the patterns of amyloid deposition (from Florbetapir F 18) and brain atrophy [ Time Frame: 1 year ]Group differences may give insight into whether TBI or PTSD is associated with reduced brain reserve causing greater cognitive impairments as indicated by neuropsychological test performance.
- Group differences in white matter integrity as assessed with Diffusion Tension Imaging (DTI) [ Time Frame: 1 year ]Group differences in axonal damage as indicated by white matter integrity measured with DTI to determine if axonal injury resulting from TBI is associated with greater amyloid accumulation or whether brain regions with axonal damage have less amyloid accumulation due to disconnection and reduced brain activity.
- Rate of change of tau deposition as measured by 18F-AV-1451 [ Time Frame: 1 year ]Rates of change in brain regions based on Tau PET neuroimaging to show that those with TBI and/or PTSD have increased evidence for AD compared to Veteran controls
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01687153
|Study Director:||Michael W. Weiner, MD||University of California, San Francisco|
|Principal Investigator:||Paul Aisen, MD||USC Alzheimer's Therapeutic Research Institute (ATRI)|
|Principal Investigator:||Ronald Petersen, MD, PhD||Mayo Clinic|