Amyloid Accumulation After Mild Traumatic Brain Injury
Primary Purpose
Traumatic Brain Injury
Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
[18F]AV-45 PET amyloid binding imaging
Sponsored by
About this trial
This is an interventional diagnostic trial for Traumatic Brain Injury focused on measuring Traumatic brain injury, mild TBI, Alzheimer's disease, [18F]AV-45 PET amyloid binding imaging
Eligibility Criteria
Inclusion criteria:
- 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
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Alzheimer disease after mild traumatic brain injury
mild traumatic brain injury without Alzheimer disease
Normal control
Arm Description
Based on the TBI registry databank, to recruit patients 1, 5, 10, 15 years after mTBI for cognitive evaluatio
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)
People aged 30 or older without mTBI or AD
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01871610
Brief Title
Amyloid Accumulation After Mild Traumatic Brain Injury
Official Title
Amyloid Accumulation After Mild Traumatic Brain Injury
Study Type
Interventional
2. Study Status
Record Verification Date
June 2012
Overall Recruitment Status
Unknown status
Study Start Date
November 2012 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
October 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury
Keywords
Traumatic brain injury, mild TBI, Alzheimer's disease, [18F]AV-45 PET amyloid binding imaging
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Alzheimer disease after mild traumatic brain injury
Arm Type
Experimental
Arm Description
Based on the TBI registry databank, to recruit patients 1, 5, 10, 15 years after mTBI for cognitive evaluatio
Arm Title
mild traumatic brain injury without Alzheimer disease
Arm Type
Experimental
Arm Description
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)
Arm Title
Normal control
Arm Type
Experimental
Arm Description
People aged 30 or older without mTBI or AD
Intervention Type
Drug
Intervention Name(s)
[18F]AV-45 PET amyloid binding imaging
Primary Outcome Measure Information:
Title
The amyloids load in brain among mild traumatic brain injury and controls in a temporal manner.
Description
The amyloids load (based on F-18-AV-45 binding) in brain among mild traumatic brain injury and controls in a temporal manner.
Time Frame
one year
Secondary Outcome Measure Information:
Title
F-18-AV-45 binding changes and cognitive function among mild traumatic brain injury and controls
Description
To evaluate the the F-18-AV-45 binding in different APOE genotypes among mild traumatic brain injury and controls
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria:
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tzu-Chen YEN, MD, PhD
Organizational Affiliation
Nuclear Medicine
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Amyloid Accumulation After Mild Traumatic Brain Injury
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