DementiaNCT01891383
Clinical Characteristics of Dementias That Occur Remotely After Traumatic Brain Injury in Retired Military Personnel
An observational study of Dementia and Traumatic Brain Injury (TBI), run by Uniformed Services University of the Health Sciences at 2 sites in United States.
Trial summary
The objective of this study is to measure the frequency and clinical types of mild cognitive impairment (MCI) or dementia that occur among up to 150 military retirees with and without a history of traumatic brain injury (TBI) among residents of the Armed Forces Retirement Home, Washington D.C. Read more about this study
- Who is it for?
- Ages 50 to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- Dementia, Traumatic Brain Injury (TBI), Mild Cognitive Impairment (MCI)
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2013to Aug 2016
- 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 95 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects for this study will be recruited from the Armed Forces Retirement Home (AFRH) in Washington, DC and the Veterans Home of California- Yountville. Up to 150 AFRH residents from both the independent living and the assisted living facilities will be invited to take the screening questionnaire and enroll in the study.
Who may be able to join
- Cases (with a history of TBI):
- Ages 50-95 years
- History of traumatic brain injury of sufficient severity to have resulted in medical attention (ascertained via the Ohio State University TBI Identification Questionnaire-OSU TBI-ID, and based on DoD/VA criteria)
- Residence in AFRH-Washington D.C. or the Veterans Home of California-Yountville
- MMSE score ≥ 20
- Capacity to provide consent to participate in research (assessment made by study physician)
Show all 14Show fewer
- Ability to read and write English
- Controls (without a history of TBI):
- Ages 50-95 years
- No history of traumatic brain injury of sufficient severity to have resulted in medical attention (ascertained via the Ohio State University TBI Identification Questionnaire-OSU TBI-ID)
- Residence in AFRH-Washington or the Veterans Home of California-Yountville
- MMSE score ≥ 20
- Capacity to provide consent or assent to participate in research
- Ability to read and write English -
Who cannot join
- Cases (with a history of TBI):
- History of penetrating brain injury
- History of disabling neurological or psychiatric condition such as epilepsy (besides posttraumatic epilepsy), multiple sclerosis, cortical stroke, hypoxic-ischemic encephalopathy, encephalitis, or schizophrenia
- Controls (without a history of TBI):
- History of disabling neurological or psychiatric condition such as epilepsy, multiple sclerosis, cortical stroke, hypoxic-ischemic encephalopathy, encephalitis, or schizophrenia
- -
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Armed Forces Retirement Home
Washington D.C., District of Columbia, 20011-8400
California Veterans Home-Yountville
Yountville, California, 94599
About this study
Official title: Endophenotypes of Dementia Associated With Traumatic Brain Injury in Retired Military Personnel
The objective of this study is to measure the frequency and clinical types of mild cognitive impairment (MCI) or dementia that occur among up to 150 military retirees with and without a history of traumatic brain injury (TBI) among residents of the Armed Forces Retirement Home, Washington D.C. and the Veterans Home of California-Yountville. Investigators will compare the characteristics of dementia in those who have had a prior TBI to the characteristics in those without a history of TBI. It is our hypothesis that the dementia or MCI among those with prior TBI has distinct neuropsychological features that distinguishes it from those with dementia or MCI without a history of TBI.
Read the detailed description
75 participants with a history of TBI will be the cases (exposed) group. A control group of 75 retirement home residents without a history of TBI who are age-matched to the cases will also be recruited. Participants will be evaluated in a single visit, which will include neurological, psychiatric, and cognitive assessment. The evaluation will take approximately 4 hours. In some cases, the evaluation may be split into two 2 hour sessions.
- Conditions
- Dementia, Traumatic Brain Injury (TBI), Mild Cognitive Impairment (MCI), Chronic Traumatic Encephalopathy (CTE), Post-traumatic Stress Disorder (PTSD)
- Keywords
- Dementia, Traumatic brain injury (TBI), Mild cognitive impairment (MCI), Chronic traumatic encephalopathy (CTE), Remote effects of TBI, Post-traumatic stress disorder (PTSD_
- Medical subject headings
- Dementia, Brain Injuries, Traumatic, Cognitive Dysfunction, Chronic Traumatic Encephalopathy, Stress Disorders, Post-Traumatic
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 |
|---|---|---|
| History of TBI | The history of TBI will be assessed by the subject's answers to the Ohio State University Traumatic Brain Injury Identification Method Short Form (OSU TBI-ID SF). | |
| No history of TBI | The history of TBI will be assessed by the subject's answers to the Ohio State University Traumatic Brain Injury Identification Method Short Form (OSU TBI-ID SF). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of dementia or MCI in the two groups (TBI versus no TBI)
The primary outcome will be the prevalence of dementia/MCI in the two groups (i.e. those with and without a TBI).
Measured: Single visit, 4 hours.
Secondary outcomes (1)
Characterization of the types of dementia or MCI that occur in the two groups (TBI or no TBI)
The characterization of the dementia and cognitive impairment within the two groups based on the neuropsychological testing will be secondary outcomes of the study.
Measured: Single visit, 4 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2013 (estimated)
- Study startJul 2013
- Primary completionJun 2016 (estimated)
- Study completionAug 2016 (estimated)
Why it stopped: New data published showing EPO to be ineffective in TBI
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uniformed Services University of the Health Sciences
- Sponsor type
- US federal agency
- Collaborators
- University of California, San Francisco
- Responsible party
- Principal investigator, Ramon Diaz-Arrastia, Uniformed Services University of the Health Sciences
- Investigators
- Ramon Diaz-Arrastia, M.D., Ph.D., Principal investigator, Uniformed Services University of the Health SciencesKristine Yaffe, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01891383
- Sponsor's protocol ID
- ERMS# 12lO9006
- Other IDs
- NEU-92-1855
- Status last verified
- Jan 2019
- First submitted
- 25 Jun 2013
- Last updated
- 18 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endophenotypes of Dementia Associated With Traumatic Brain Injury in Retired Military Personnel
- ClinicalTrials.gov ID
- NCT01891383
- Acronym / sponsor ID
- ERMS# 12lO9006
- Conditions
- Dementia, Traumatic Brain Injury (TBI), Mild Cognitive Impairment (MCI), Chronic Traumatic Encephalopathy (CTE), Post-traumatic Stress Disorder (PTSD)
- Keywords
- Dementia, Traumatic brain injury (TBI), Mild cognitive impairment (MCI), Chronic traumatic encephalopathy (CTE), Remote effects of TBI, Post-traumatic stress disorder (PTSD_
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: New data published showing EPO to be ineffective in TBI
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Uniformed Services University of the Health SciencesUS federal agency
- Collaborators
- University of California, San Francisco
- Study start
- Jul 2013
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Aug 2016 (estimated)
- First posted
- 3 Jul 2013 (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.
The objective of this study is to measure the frequency and clinical types of mild cognitive impairment (MCI) or dementia that occur among up to 150 military retirees with and without a history of traumatic brain injury (TBI) among residents of the Armed Forces Retirement Home, Washington D.C. and the Veterans Home of California-Yountville. Investigators will compare the characteristics of dementia in those who have had a prior TBI to the characteristics in those without a history of TBI. It is our hypothesis that the dementia or MCI among those with prior TBI has distinct neuropsychological features that distinguishes it from those with dementia or MCI without a history of TBI.
Detailed description
75 participants with a history of TBI will be the cases (exposed) group. A control group of 75 retirement home residents without a history of TBI who are age-matched to the cases will also be recruited. Participants will be evaluated in a single visit, which will include neurological, psychiatric, and cognitive assessment. The evaluation will take approximately 4 hours. In some cases, the evaluation may be split into two 2 hour sessions.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| History of TBI | – | –The history of TBI will be assessed by the subject's answers to the Ohio State University Traumatic Brain Injury Identification Method Short Form (OSU TBI-ID SF). |
| No history of TBI | – | –The history of TBI will be assessed by the subject's answers to the Ohio State University Traumatic Brain Injury Identification Method Short Form (OSU TBI-ID SF). |
Who may qualify
- Ages
- 50 to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects for this study will be recruited from the Armed Forces Retirement Home (AFRH) in Washington, DC and the Veterans Home of California- Yountville. Up to 150 AFRH residents from both the independent living and the assisted living facilities will be invited to take the screening questionnaire and enroll in the study.
Key inclusion criteria (14 listed)
- Ages 50-95 years
- History of traumatic brain injury of sufficient severity to have resulted in medical attention (ascertained via the Ohio State University TBI Identification Questionnaire-OSU TBI-ID, and based on DoD/VA criteria)
- Residence in AFRH-Washington D.C. or the Veterans Home of California-Yountville
- MMSE score ≥ 20
- Capacity to provide consent to participate in research (assessment made by study physician)
Key exclusion criteria (6 listed)
- History of penetrating brain injury
- History of disabling neurological or psychiatric condition such as epilepsy (besides posttraumatic epilepsy), multiple sclerosis, cortical stroke, hypoxic-ischemic encephalopathy, encephalitis, or schizophrenia
- History of disabling neurological or psychiatric condition such as epilepsy, multiple sclerosis, cortical stroke, hypoxic-ischemic encephalopathy, encephalitis, or schizophrenia
- -
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
Prevalence of dementia or MCI in the two groups (TBI versus no TBI)
Time frame: Single visit, 4 hours.
The primary outcome will be the prevalence of dementia/MCI in the two groups (i.e. those with and without a TBI).
1 secondary outcome
Characterization of the types of dementia or MCI that occur in the two groups (TBI or no TBI)
Time frame: Single visit, 4 hours.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2019.
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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.
Ramon Diaz-Arrastia, M.D., Ph.D. principal investigator
Uniformed Services University of the Health Sciences
Kristine Yaffe, MD principal investigator
University of California, San Francisco
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dementia and Traumatic Brain Injury (TBI), run by Uniformed Services University of the Health Sciences at 2 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 14 inclusion and 6 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: withdrawn, as of the sponsor's last update on 18 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 was withdrawn before enrolling participants, so there are no results.
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?
Prevalence of dementia or MCI in the two groups (TBI versus no TBI) (time frame: Single visit, 4 hours.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jan 2019.