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Amyloid Accumulation After Mild Traumatic Brain Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01871610
Recruitment Status : Unknown
Verified June 2012 by Chang Gung Memorial Hospital.
Recruitment status was:  Enrolling by invitation
First Posted : June 7, 2013
Last Update Posted : June 7, 2013
Information provided by (Responsible Party):
Chang Gung Memorial Hospital

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.

Condition or disease Intervention/treatment Phase
Traumatic Brain Injury Drug: [18F]AV-45 PET amyloid binding imaging Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Amyloid Accumulation After Mild Traumatic Brain Injury
Study Start Date : November 2012
Actual Primary Completion Date : November 2012
Estimated Study Completion Date : October 2013

Arm Intervention/treatment
Experimental: Alzheimer disease after mild traumatic brain injury
Based on the TBI registry databank, to recruit patients 1, 5, 10, 15 years after mTBI for cognitive evaluatio
Drug: [18F]AV-45 PET amyloid binding imaging
Experimental: mild traumatic brain injury without Alzheimer disease
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)
Drug: [18F]AV-45 PET amyloid binding imaging
Experimental: Normal control
People aged 30 or older without mTBI or AD
Drug: [18F]AV-45 PET amyloid binding imaging

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. F-18-AV-45 binding changes and cognitive function among mild traumatic brain injury and controls [ Time Frame: one year ]
    To evaluate the the F-18-AV-45 binding in different APOE genotypes among mild traumatic brain injury and controls

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01871610

Sponsors and Collaborators
Chang Gung Memorial Hospital
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Study Director: Tzu-Chen YEN, MD, PhD Nuclear Medicine

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Responsible Party: Chang Gung Memorial Hospital Identifier: NCT01871610     History of Changes
Other Study ID Numbers: 100-4313A
First Posted: June 7, 2013    Key Record Dates
Last Update Posted: June 7, 2013
Last Verified: June 2012
Keywords provided by Chang Gung Memorial Hospital:
Traumatic brain injury
mild TBI
Alzheimer's disease
[18F]AV-45 PET amyloid binding imaging
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Brain Concussion
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Head Injuries, Closed
Wounds, Nonpenetrating