NCT01871610 · Phase 2 · UNKNOWN
Amyloid Accumulation After Mild Traumatic Brain Injury
This study looks at whether people who had a mild head injury years ago show more amyloid, a protein tied to Alzheimer's, in the brain. Researchers use a PET scan with a tracer called AV-45 to measure it. It is a Phase 2 trial, an early-stage study, and nothing is being tested as a therapy.
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
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2013-06-07