A Study of Brain Aging in Vietnam War Veterans

NCT01687153 | Completed DMC

• 4 other identifiers: ADC-044W81XWH-12-2-0012W81XWH-13-1-0259W81XWH-14-1-0462
• Study Type: observational
• Target: 289
• Locations: 1 country
• Sites: 19

Brief Summary

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.

Conditions

Traumatic Brain Injury; Post Traumatic Stress Disorder; Alzheimer's Disease; Mild Cognitive Impairment

Keywords

traumatic brain injury (TBI); post traumatic stress disorder (PTSD); Alzheimer's disease (AD); mild cognitive impairment (MCI); dementia; biomarkers; amyloid; neuroimaging; cognition disorder; tau

Outcome Measures

Primary Outcomes (3)

• 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

  1 Year

Secondary Outcomes (4)

• 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

Study Arms (6)

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

Controls

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

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Vietnam Veterans

You may not qualify if:

• General (applies to each cohort):
• 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.
• General (applies to each cohort):
• MCI/dementia;

Sponsors & Collaborators

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

Study Sites (19)

Banner Sun Health Research Institute

Sun City, Arizona, 85351, United States

Location

University of California, Irvine

Irvine, California, 92697, United States

Location

University of California, San Diego

La Jolla, California, 92093, United States

Location

University of Southern California

Los Angeles, California, 90033, United States

Location

VA Palo Alto HSC / Stanford School of Medicine

Palo Alto, California, 94304, United States

Location

University of California, San Francisco

San Francisco, California, 94117, United States

Location

Georgetown University

Washington D.C., District of Columbia, 20057, United States

Location

Howard University

Washington D.C., District of Columbia, 20060, United States

Location

Wien Center for Clinical Research

Miami Beach, Florida, 33140, United States

Location

Premiere Research Institute

West Palm Beach, Florida, 33407, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Cornell Medical Center

New York, New York, 10021, United States

Location

Columbia University

New York, New York, 10032, United States

Location

University of Rochester Medical Center

Rochester, New York, 14620, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Roper St Francis Healthcare

Charleston, South Carolina, 29401, United States

Location

U of WA / VA Puget Sound Alzheimer's Disease Research Center

Seattle, Washington, 98108, United States

Location

University of Wisconsin

Madison, Wisconsin, 53705, United States

Location

Related Publications (4)

• 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.

  PMID: 17476317 BACKGROUND

• 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.

  PMID: 20451868 BACKGROUND

• 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.

  PMID: 20083042 BACKGROUND

• 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.

  PMID: 19636049 BACKGROUND

Related Links

• Alzheimer's Disease Neuroimaging Initiative (ADNI)
• U.S. Department of Veterans Affairs
• Laboratory of Neuro Imaging (LONI)
• Alzheimer's Therapeutic Research Institute

Biospecimen

Retention: SAMPLES WITH DNA

blood, urine, cerobrospinal fluid

MeSH Terms

Conditions

Brain Injuries, Traumatic; Stress Disorders, Post-Traumatic; Alzheimer Disease; Cognitive Dysfunction; Dementia; Cognition Disorders; Pick Disease of the Brain

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Frontotemporal Dementia; Frontotemporal Lobar Degeneration

Study Officials

• Michael W. Weiner, MD

  University of California, San Francisco

  STUDY DIRECTOR

• Paul Aisen, MD

  USC Alzheimer's Therapeutic Research Institute (ATRI)

  PRINCIPAL INVESTIGATOR

• Ronald Petersen, MD, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 31, 2012
• First Posted: September 18, 2012
• Study Start: October 1, 2012
• Primary Completion: September 21, 2021
• Study Completion: September 21, 2021
• Last Updated: November 29, 2021

Record last verified: 2021-11

Locations

US (19)