Amyloid Accumulation After Mild Traumatic Brain Injury (TBI)

September 17, 2019 updated by: Chaur-jong Hu, Taipei Medical University Shuang Ho Hospital

Observational Study for Amyloid Accumulation After Mild Traumatic Brain

We are extending the researches of Taiwan neurosurgery traumatic brain injury (TBI) database which is led by Professor WT Chiu in Taipei Medical University and will recruit mild TBI (mTBI) participants who have ever been registered in the database. This database has been established for over 15 years and contains the information of over 150000 patients. It is one of the largest TBI database in the world.

TBI usually results from traffic accidents, falls or violence events. Most of the victims are young people and the victims suffer from life-threatening and mental-physical deficits. Mild TBI (mTBI) usually was neglected before because its symptoms, signs are mild and mTBI patients usually were not obtained enough initial treatment. Therefore, mTBI might result in long-term cognitive and affective impairments, such as depression, indifference, anxiety, memory impairment, loss of attention and executive function. These late effects not only decrease the life quality of patients and their family but also increase the social and medical burden.

Recent epidemiology studies have pointed out that TBI would increase the risk for dementia, especially Alzheimer disease (AD) by 2-4 times. However, the association between TBI severity, number of repeats, genetic factors and onset of AD remains further investigation.

Amyloid-β (Aβ) plaques and neurofibrillary tangles are the pathological hallmarks for AD. Accumulation of Aβ is considered to be the first step of pathophysilogy of AD. Compelling researches have supported TBI accelerates the formation and accumulation of Aβ. These findings could link TBI with AD but the previous researches had limitations. There was lack of mTBI pathology data so the impacts of mTBI on Aβ accumulation were still obscure. By amyloid-PET, we could study the effects of mTBI on the accumulation of Aβ and this tool could be helpful for understanding the real impacts and pathophysiological mechanisms of mTBI on AD.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

We will conduct amyloid PET, cognitive examination and APOE genotyping for the individuals who had traumatic brain injury (TBI) in 1 year, 5 years, 10 years and 15 years ago. Age-gender-matched controls without TBI will be recruited.

The main aim of this study is to evaluate the impact of TBI on amyloid accumulation in the brain. In the mean time, we also will test the effects of APOE genotypes in amyloid accumulation after TBI and the clinical relevants, in terms of cognitive function.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • New Taipei City, Taiwan, 235
        • Recruiting
        • Shuang Ho Hospital, Taipei Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

patients aged over 55 years with/without traumatic brain injury 1, 5, 10, 15 years ago

Description

Inclusion Criteria:

  • a. had TBI in 1, 5, 10 and 15 years ago b. mild injury in TBI (initial GCS = 13-15) c. had MRI or CT evaluation after TBI d. aged 18 years or older (55 years better) e. have agreement and have signed the informed consent form by him/herself or his/her legal representative

Exclusion Criteria:

  • a. participating in another clinical trials which might interfere the current finding b. not sure the timing of TBI c. contaminant the symptoms with injury, skull fracture, intracranial hemorrhage, craniotomy, and death d. moderate (initial GCS = 9-12) or severe (initial GCS < 8) injury in TBI e. had wound with gunshot or puncture f. loss of consciousness over 30 minutes after TBI g. loss of memory for over 1 day after TBI h. have no MRI or CT evaluation of brain after TBI or have obstructive ischemia after MRI or CT evaluation i. have uremia, liver cirrhosis, heart failure, pulmonary edema, coagulation disorders and other major diseases j. pregnant woman or emotional instability k. the age less than 18 years (55 years better) l. unable to collect blood sample by peripheral vein m. determination of inappropriate participants in the clinical trail of PI

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
traumatic brain injury
mild traumatic brain injury
Other: traumatic brain injury
mild TBI, GCS >/=13 after traumatic brain injury
Other Names:
  • TBI
without TBI

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
amyloid accumulation by amyloid PET
Time Frame: day one
amyloid PET after participation
day one

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
mini-mental status examination (MMSE) for cognitive function
Time Frame: day one
neuro-psychological test by use of mini-mental status examination (MMSE) to measure the cognitive function of participants
day one

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Time Frame
APOE genotypes
Time Frame: day one
day one

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Taipei Medical University Shuang Ho Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Chang Gung Memorial Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Chaur-Jong Hu, M.D., Department of Neurology, Shuang Ho Hospital, Taipei Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2019

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 18, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 15, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 6, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 8, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 19, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 17, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DOH101-TD-PB-111-NSC017 (Other Grant/Funding Number: National Scince council of Taiwan)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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