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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
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

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

30 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    May 2, 2013
    Last Updated
    June 3, 2013
    Sponsor
    Chang Gung Memorial Hospital
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    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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