The DIAGNOSE CTE Research Project-II

NCT06860828 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 350

Last updated 2026-03-19

No results posted yet for this study

Summary

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.

Conditions

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

Sponsors & Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

    collaborator NIH
  • University of California, San Francisco (UCSF) Alzheimer Disease Research Center (ADRC)

    collaborator UNKNOWN
  • 1Florida ADRC, University of Florida

    collaborator UNKNOWN
  • University of Texas Health Science Center at San Antonio (South Texas) ADRC

    collaborator UNKNOWN
  • Laboratory of Neuro Imaging (LONI) at University of Southern California (USC)

    collaborator UNKNOWN
  • Concussion Legacy Foundation (CLF)

    collaborator UNKNOWN
  • Banner Alzheimer's Institute

    collaborator OTHER
  • Boston University

    lead OTHER

Principal Investigators

  • Michael Alosco, PhD · Boston University Alzheimer's Disease and CTE Center

Eligibility

Min Age
50 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-04-09
Primary Completion
2029-07-31
Completion
2029-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06860828 on ClinicalTrials.gov