Traumatic Brain InjuryDOD-ADNINCT01687153
A Study of Brain Aging in Vietnam War Veterans
An observational study of Traumatic Brain Injury and Post Traumatic Stress Disorder, run by University of Southern California at 19 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Traumatic Brain Injury, Post Traumatic Stress Disorder, Alzheimer's Disease
- How many people
- 289 participants
- Where
- 19 sitesUnited States
- Study dates
- Oct 2012to 21 Sep 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Vietnam Veterans
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
United States19 sites
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Roper St Francis Healthcare
Charleston, South Carolina, 29401
Rush University Medical Center
Chicago, Illinois, 60612
Duke University Medical Center
Durham, North Carolina, 27710
University of California, Irvine
Irvine, California, 92697
University of California, San Diego
La Jolla, California, 92093
University of Southern California
Los Angeles, California, 90033
University of Wisconsin
Madison, Wisconsin, 53705
Wien Center for Clinical Research
Miami Beach, Florida, 33140
Cornell Medical Center
New York, New York, 10021
Columbia University
New York, New York, 10032
VA Palo Alto HSC / Stanford School of Medicine
Palo Alto, California, 94304
University of Rochester Medical Center
Rochester, New York, 14620
University of California, San Francisco
San Francisco, California, 94117
U of WA / VA Puget Sound Alzheimer's Disease Research Center
Seattle, Washington, 98108
Banner Sun Health Research Institute
Sun City, Arizona, 85351
Georgetown University
Washington D.C., District of Columbia, 20057
Howard University
Washington D.C., District of Columbia, 20060
Premiere Research Institute
West Palm Beach, Florida, 33407
About this study
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)
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.
Read the detailed description
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.
- 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
- Medical subject headings
- Brain Injuries, Traumatic, Stress Disorders, Post-Traumatic, Alzheimer Disease, Cognitive Dysfunction, Dementia, Cognition Disorders, Pick Disease of the Brain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 1 year
Group differences in the patterns of amyloid deposition (from Florbetapir F 18) and brain atrophy
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.
Measured: 1 year
Group differences in white matter integrity as assessed with Diffusion Tension Imaging (DTI)
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.
Measured: 1 year
Rate of change of tau deposition as measured by 18F-AV-1451
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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2012 (estimated)
- Study startOct 2012
- Primary completion21 Sep 2021
- Study completion21 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 289 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense, Telemedicine & Advanced Technology Research Center, Northern California Institute of Research and Education, San Francisco Veterans Affairs Medical Center, Alzheimer's Therapeutic Research Institute
- Responsible party
- Principal investigator, Paul Aisen, University of Southern California
- Investigators
- Michael W. Weiner, MD, Study director, University of California, San FranciscoPaul Aisen, MD, Principal investigator, USC Alzheimer's Therapeutic Research Institute (ATRI)Ronald Petersen, MD, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01687153
- Sponsor's protocol ID
- ADC-044
- Other IDs
- W81XWH-12-2-0012, W81XWH-13-1-0259, W81XWH-14-1-0462
- Acronym
- DOD-ADNI
- Status last verified
- Nov 2021
- First submitted
- 31 Aug 2012
- Last updated
- 29 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 17476317Weiner 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.
PubMed 20451868Jack 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.
PubMed 20083042Vemuri 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.
PubMed 19636049
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01687153
- Acronym / sponsor ID
- DOD-ADNI / ADC-044
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 289 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- United States Department of Defense, Telemedicine & Advanced Technology Research Center, Northern California Institute of Research and Education, San Francisco Veterans Affairs Medical Center, Alzheimer's Therapeutic Research Institute
- Study start
- Oct 2012
- Primary completion
- 21 Sep 2021 (actual)
- Study completion
- 21 Sep 2021 (actual)
- First posted
- 18 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Vietnam Veterans
Key inclusion criteria (16 listed)
- 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);
Key exclusion criteria (24 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
4 secondary outcomes
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 in white matter integrity as assessed with Diffusion Tension Imaging (DTI)
Time frame: 1 year
Rate of change of tau deposition as measured by 18F-AV-1451
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2021.
- Background: PubMed 17476317Mueller 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.
- Background: PubMed 20451868Weiner 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.
- Background: PubMed 20083042Jack 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.
- Background: PubMed 19636049Vemuri 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.
- Alzheimer's Disease Neuroimaging Initiative (ADNI)Link provided by the sponsor.
- U.S. Department of Veterans AffairsLink provided by the sponsor.
- Laboratory of Neuro Imaging (LONI)Link provided by the sponsor.
- Alzheimer's Therapeutic Research InstituteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael W. Weiner, MD study director
University of California, San Francisco
Paul Aisen, MD principal investigator
USC Alzheimer's Therapeutic Research Institute (ATRI)
Ronald Petersen, MD, PhD principal investigator
Mayo Clinic
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Traumatic Brain Injury and Post Traumatic Stress Disorder, run by University of Southern California at 19 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rates of change in brain regions based on neuroimaging (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01687153, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2021.