Traumatic Brain InjuryPhase 2NCT01871610
Amyloid Accumulation After Mild Traumatic Brain Injury
A Phase 2 study testing [18F]AV-45 PET amyloid binding imaging in people with Traumatic Brain Injury, run by Chang Gung Memorial Hospital.
Trial summary
There will be 200 participants, who aged 30 years or older with TBI in 1,5,10,15 years ago and GCS=13-15 will be recruited. Another group of 200 participants with the same age and gender and without TBI will be recruited as the controls. Read more about this study
- Who is it for?
- Ages 30 years and olderHealthy volunteers can take part
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- [18F]AV-45 PET amyloid binding imaging
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Nov 2012to Oct 2013
- Phase
- Phase 2
- 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 30 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The individuals are listed in the Taipei medical university traumatic brain injury databank and had TBI in 1, 5, 10 and 15 years ago. There are about 200 individuals undergo telephone interview/invitation, blood test for genotyping and neuropsychological tests. 30 participants will be selected randomly among the 200 individuals.
- mild injury in TBI (initial GCS = 13-15)
- had MRI or CT evaluation after TBI
- aged 30 years or older better
- agreed by principal investigator
- have agreement and have signed the informed consent form by him/herself or his/her legal representative
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- Main exclusion criteria:
- participating in another clinical trials which might interfere the current finding.
- not sure the timing of TBI
- contaminant the symptoms with injury, skull fracture, intracranial hemorrhage, craniotomy, and death
- moderate (initial GCS = 9-12) or severe (initial GCS < 8) injury in TBI
- had wound with gunshot or puncture
- loss of consciousness over 30 minutes after TBI
- loss of memory for over 1 day after TBI
- have no MRI or CT evaluation of brain after TBI or have obstructive ischemia after MRI or CT evaluation
- have uremia, liver cirrhosis, heart failure, pulmonary edema, coagulation disorders and other major diseases
- pregnant woman or emotional instability
- the age less than 18 years (30 years better)
- unable to collect blood sample by peripheral vein
- determination of inappropriate participants in the clinical trail of PI
Who cannot join
None listed.
About this study
There will be 200 participants, who aged 30 years or older with TBI in 1,5,10,15 years ago and GCS=13-15 will be recruited. Another group of 200 participants with the same age and gender and without TBI will be recruited as the controls. All of them will undergo AD8 questionnaire for dementia screening and APOE4 genotyping. Further CASI and CDR will be tested for the confirmation of dementia diagnosis for the individuals with AD8 scaore >/=2. 10 TBI with dementia, 20 TBI without dementia and 10 controls will be selected randomly for AV45 amylid PET study.
There will also be 10 participants without traumatic brain injury and interested in this study, aged 55 years or older better.
Read the detailed description
We will examine the mTBI patients in a long-term follow-up manner by cognitive tests and A-PET. This is a novel study for linking mTBI and AD by solid, reliable methods, in terms of A-PET and cognitive function tests. In addition, we will figure out the importance of APOE genotypes for amyloid accumulation and cognitive impairment. These results should shed light on the further clinical studies and amyloid-cleaning therapy for prevention and treatment for dementia after mTBI.
- Conditions
- Traumatic Brain Injury
- Being tested
- [18F]AV-45 PET amyloid binding imaging
- Keywords
- Traumatic brain injury, mild TBI, Alzheimer's disease, [18F]AV-45 PET amyloid binding imaging
- Medical subject headings
- Brain Injuries, Traumatic, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[18F]AV-45 PET amyloid binding imagingDrug
| Study group | Role | What they receive |
|---|---|---|
| Alzheimer disease after mild traumatic brain injury | Experimental | Based on the TBI registry databank, to recruit patients 1, 5, 10, 15 years after mTBI for cognitive evaluatio Receives: Drug: [18F]AV-45 PET amyloid binding imaging |
| mild traumatic brain injury without Alzheimer disease | Experimental | To recruit patients 1, 5, 10, 15 years after mTBI with or without cognitive impairment and age-gender-matched controls (a total of 3 groups) for amyloid- positron emission tomography (A-PET) Receives: Drug: [18F]AV-45 PET amyloid binding imaging |
| Normal control | Experimental | People aged 30 or older without mTBI or AD Receives: Drug: [18F]AV-45 PET amyloid binding imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
The amyloids load in brain among mild traumatic brain injury and controls in a temporal manner.
The amyloids load (based on F-18-AV-45 binding) in brain among mild traumatic brain injury and controls in a temporal manner.
Measured: one year
Secondary outcomes (1)
F-18-AV-45 binding changes and cognitive function among mild traumatic brain injury and controls
To evaluate the the F-18-AV-45 binding in different APOE genotypes among mild traumatic brain injury and controls
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2013 (estimated)
- Study startNov 2012
- Primary completionNov 2012
- Study completionOct 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tzu-Chen YEN, MD, PhD, Study director, Nuclear Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01871610
- Sponsor's protocol ID
- 100-4313A
- Status last verified
- Jun 2012
- First submitted
- 2 May 2013
- Last updated
- 7 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Amyloid Accumulation After Mild Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT01871610
- Acronym / sponsor ID
- 100-4313A
- Conditions
- Traumatic Brain Injury
- Keywords
- Traumatic brain injury, mild TBI, Alzheimer's disease, [18F]AV-45 PET amyloid binding imaging
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Nov 2012 (actual)
- Study completion
- Oct 2013 (estimated)
- First posted
- 7 Jun 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.
There will be 200 participants, who aged 30 years or older with TBI in 1,5,10,15 years ago and GCS=13-15 will be recruited. Another group of 200 participants with the same age and gender and without TBI will be recruited as the controls. All of them will undergo AD8 questionnaire for dementia screening and APOE4 genotyping. Further CASI and CDR will be tested for the confirmation of dementia diagnosis for the individuals with AD8 scaore >/=2. 10 TBI with dementia, 20 TBI without dementia and 10 controls will be selected randomly for AV45 amylid PET study.
There will also be 10 participants without traumatic brain injury and interested in this study, aged 55 years or older better.
Detailed description
We will examine the mTBI patients in a long-term follow-up manner by cognitive tests and A-PET. This is a novel study for linking mTBI and AD by solid, reliable methods, in terms of A-PET and cognitive function tests. In addition, we will figure out the importance of APOE genotypes for amyloid accumulation and cognitive impairment. These results should shed light on the further clinical studies and amyloid-cleaning therapy for prevention and treatment for dementia after mTBI.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Alzheimer disease after mild traumatic brain injury | Experimental | Drug: [18F]AV-45 PET amyloid binding imagingBased on the TBI registry databank, to recruit patients 1, 5, 10, 15 years after mTBI for cognitive evaluatio |
| mild traumatic brain injury without Alzheimer disease | Experimental | Drug: [18F]AV-45 PET amyloid binding imagingTo recruit patients 1, 5, 10, 15 years after mTBI with or without cognitive impairment and age-gender-matched controls (a total of 3 groups) for amyloid- positron emission tomography (A-PET) |
| Normal control | Experimental | Drug: [18F]AV-45 PET amyloid binding imagingPeople aged 30 or older without mTBI or AD |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- The individuals are listed in the Taipei medical university traumatic brain injury databank and had TBI in 1, 5, 10 and 15 years ago. There are about 200 individuals undergo telephone interview/invitation, blood test for genotyping and neuropsychological tests. 30 participants will be selected randomly among the 200 individuals.
- mild injury in TBI (initial GCS = 13-15)
- had MRI or CT evaluation after TBI
- aged 30 years or older better
- agreed by principal investigator
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [18F]AV-45 PET amyloid binding imaging | Drug | Alzheimer disease after mild traumatic brain injury, Normal control, mild traumatic brain injury without Alzheimer disease |
Primary outcome
The amyloids load in brain among mild traumatic brain injury and controls in a temporal manner.
Time frame: one year
The amyloids load (based on F-18-AV-45 binding) in brain among mild traumatic brain injury and controls in a temporal manner.
1 secondary outcome
F-18-AV-45 binding changes and cognitive function among mild traumatic brain injury and controls
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2013.
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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.
Tzu-Chen YEN, MD, PhD study director
Nuclear Medicine
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing [18F]AV-45 PET amyloid binding imaging in people with Traumatic Brain Injury, run by Chang Gung Memorial Hospital.
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 20 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 7 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
The amyloids load in brain among mild traumatic brain injury and controls in a temporal manner. (time frame: one year). 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 7 Jun 2013.