Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:45 AM
Ignite Modification Date:
2025-12-25 @ 12:45 AM
NCT ID:
NCT02191267
Eligibility Criteria:
1. Presumed CTE Group (includes 20 former NFL players who will have already participated in the NIH-funded R01 "DETECT" (Diagnosis and Evaluation of Traumatic Encephalopathy with Clinical Tests) study (Stern, PI; Shenton, Neuroimaging Site PI). Eligibility criteria for presumed CTE group and the control group are based on findings from the DETECT study.
Inclusion Criteria:
* significant cognitive impairment (and impairment in at least one of the following):
* behavioral (e.g., impulsivity, aggression),
* mood (e.g., elevated depression measures, elevated suicidality),
* and/or motor (e.g., impairments evidenced in neurological examination;
* demonstrated abnormalities on svMRI, DTI, or MRS
Exclusion Criteria:
* weight \> 350 lbs
* known metallic implants preventing MRI
* history of stroke
* non-English speaking
* significant vision or hearing impairment
* unable to provide written informed consent
2. Control Group (comprised of 5 male participants selected from 50 control subjects in the DETECT study).
Inclusion Criteria:
* no history of mTBI or exposure to repetitive brain trauma
* normal functioning on DETECT clinical measures
* no abnormalities on svMRI, DTI, or MRS
Exclusion Criteria:
* weight \> 350 lbs
* known metallic implants preventing MRI
* history of stroke or other neurological disease
* non-English speaking
* significant vision or hearing impairment
3. AD Dementia Group (comprised of 5 male participants recruited from the BU Alzheimer's Disease Center (ADC) Clinical Core Registry (Dr. Stern, PI).
Inclusion Criteria:
* diagnosis of Dementia due to AD using the NIA-AA (National Institute on Aging-Alzheimer's Association) criteria
* Clinical Dementia Rating Global Score of 1.0,
* a positive florbetapir PET study,
* CSF p-tau/Aβ consistent with AD.
Exclusion Criteria:
* history of TBI, mTBI or or exposure to repetitive brain trauma
* weight \> 350 lbs
* known metallic implants preventing MRI
* history of stroke or other neurological disease
* non-English speaking
* significant vision or hearing impairment
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
40 Years
Maximum Age:
69 Years
Study:
NCT02191267
Study Brief:
Protocol Section:
NCT02191267