A Study of Brain Aging in Vietnam War Veterans



Status:Recruiting
Conditions:Alzheimer Disease, Cognitive Studies, Neurology, Psychiatric
Therapuetic Areas:Neurology, Psychiatry / Psychology
Healthy:No
Age Range:50 - 90
Updated:2/21/2019
Start Date:October 2012
End Date:September 2019
Contact:Jacqueline Hayes
Email:Jacqueline.Hayes@va.gov
Phone:415-221-4810

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

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.

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.

Participants will be classified as either controls, TBI, or PTSD. General
Inclusion/Exclusion Criteria will apply to all groups, with specific criteria for each
group as described below.

Inclusion Criteria:

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.

Specific Inclusion Criteria for 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 no disability at all.

Specific Inclusion Criteria for TBI:

- 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

Specific Inclusion Criteria for PTSD:

- 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:

General (applies to each cohort):

- 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.

Specific Exclusion Criteria for Controls:

• Exclusionary criteria applied to TBI/PTSD (outlined below) will be applied to controls.

Specific Exclusion Criteria for TBI:

• 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).

Specific Exclusion Criteria for PTSD:

- 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.
We found this trial at
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New York, New York 10021
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75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
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Los Angeles, California 90033
213) 740-2311
University of Southern California The University of Southern California is one of the world’s leading...
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116th St and Broadway
New York, New York 10027
(212) 854-1754
Columbia University In 1897, the university moved from Forty-ninth Street and Madison Avenue, where it...
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601 Elmwood Avenue
Rochester, New York 14642
(585) 275-2100
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Charleston, South Carolina 29401
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1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
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Irvine, California 92697
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9500 Gilman Dr
La Jolla, California 92093
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Madison, Wisconsin 53792
(608) 263-2400
University of Wisconsin In achievement and prestige, the University of Wisconsin–Madison has long been recognized...
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Miami Beach, Florida 33140
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3801 Miranda Avenue
Palo Alto, California 94304
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San Francisco, California 94143
Principal Investigator: Howard Rosen, MD
Phone: 415-514-5753
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Washington, District of Columbia 20060
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3700 O St NW
Washington, District of Columbia 20057
(202) 687-0100
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West Palm Beach, Florida 33407
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