The DIAGNOSE CTE Research Project-II

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Boston University
Study ID
NCT06860828
Status
Enrolling By Invitation

Conditions

  • Alzheimer Disease
  • Alzheimer Disease and Related Dementias (ADRD)
  • Brain Injuries, Traumatic
  • Chronic Traumatic Encephalopathy (CTE)

Eligibility Criteria

Sex
MALE
Age
50 Years - N/A
Healthy Volunteers
Accepted

Study Details

Each year, millions of people are exposed to repetitive head impacts (RHI) through contact sports. RHI can result in concussions and asymptomatic non-concussions to confer risk for Alzheimer's disease (AD) and related dementias (ADRD) including chronic traumatic encephalopathy (CTE). Presently, a diagnosis of CTE can only be rendered at autopsy and it has been neuropathological diagnosed in several hundreds of American football players particularly those who played at elite levels (college and professional). The ability to make an accurate diagnosis of CTE is needed to facilitate research on risk factors, mechanisms, prevention, and treatment. In 2015, the investigators were awarded a NINDS funded 7-year U01 known as the DIAGNOSE CTE Research Project (NCT02798185) designed to develop biomarkers, characterize the clinical presentation, and examine genetic and RHI risk factors for CTE. This current 5-year NIH funded multicenter study DIAGNOSE CTE Research Project-II will build on and extend those findings.

Key Dates

Start date
Apr 9, 2025
Status verified
May 2026
Primary completion
Jul 31, 2029
Completion
Jul 31, 2029

Study Design

Enrollment
350 participants (estimated)

Arms

  • Arm: Former college and professional football players
    150 football players from DIAGNOSE I and an additional 75 former college and football players will be enrolled in DIAGNOSE II for a total anticipated cohort size of 225.
  • Arm: Asymptomatic non-RHI/Controls
    50/60 controls from DIAGNOSE I and an additional 25 controls will be enrolled in DIAGNOSE II for a total anticipated cohort size of 75.
  • Arm: Cognitive impairment due to Alzheimer's disease (AD-CI)
    50 participants with cognitive impairment due to AD will be enrolled in DIAGNOSE II for an anticipated cohort size of 50.

Primary Outcome Measure

Delayed recall memory [ Time Frame: 12 months ]

Locations (5)

FacilityCityStateZIPSite coordinators
Banner Alzheimer's Institute (BAI) and Mayo Clinic ArizonaPhoenixArizona85006-
University of California, San Francisco (UCSF) Alzheimer Disease Research Center (ADRC)San FranciscoCalifornia94143-
1Florida ADRC, University of FloridaGainesvilleFlorida32610-
Boston University Alzheimer Disease Research Center (ADRC)BostonMassachusetts02118-
South Texas ADRC University of Texas Health Science Center at San AntonioSan AntonioTexas78229-

Find similar trials in Phoenix, AZ

By condition
Alzheimer's disease
By specialty
NeurologyDementia careBrain disordersGeriatrics
By research site
Banner Alzheimer's Institute (BAI) and Mayo Clinic Arizona· Phoenix, AZUniversity of California, San Francisco (UCSF) Alzheimer Disease Research Center (ADRC)· San Francisco, CA1Florida ADRC, University of Florida· Gainesville, FLBoston University Alzheimer Disease Research Center (ADRC)· Boston, MASouth Texas ADRC University of Texas Health Science Center at San Antonio· San Antonio, TX

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