Diverse VCID "Vascular Cognitive Impairment and Dementia"

Last updated: September 12, 2023
Sponsor: National Institute of Neurological Disorders (NINDS) and Stroke/National Institutes of Health
Overall Status: Active - Recruiting

Phase

4

Condition

Mild Cognitive Impairment

Treatment

N/A

Clinical Study ID

TX310398
1712877
  • Ages 65-90
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The nationwide, NIH-sponsored, Diverse Vascular Contributions to Cognitive Impairment and Dementia (DVCID) Study aims to investigate how vascular health and abnormal white matter signals in the brain affect thinking in three patient populations, namely Caucasian, African American, and Hispanic/Latino. The presence of white matter signals (white matter hyperintensities) shows that there is damage to the blood vessels in the brain, resulting in vascular cognitive impairment and dementia (VCID).

Eligibility Criteria

Inclusion

Inclusion Criteria:

The minimum criteria for participation in the study include:

  • Adults between the ages of 65-90
  • Cognitive Complaint: If a patient has experienced a change in memory or other aspects of thinking in the last 1-3 years.
  • Must be able to have MRI to detect the Presence of any white matter hyperintensity (WMH) abnormalities seen on FLAIR imaging.
  • Race and Ethnicity are European/White, African American/Black, or Hispanic/Latino. The study aims to recruit 750 participants from each race and ethnicity, for a total of 2,250 participants.

Exclusion

Exclusion Criteria:

The main exclusion criteria include:

  • History of stroke
  • Clinical Dementia
  • Traumatic Brain Injury (TBI) of moderate or greater severity
  • CNS Infection
  • Unstable major medical illness
  • History of drug or alcohol abuse within the last 5 years
  • Sensory or motor defect that precludes neuropsychological testing

Study Design

Total Participants: 2250
Study Start date:
March 24, 2023
Estimated Completion Date:
August 31, 2027

Study Description

The study will require 3 visits: • A baseline visit, plus 2 subsequent annual follow-up visits over 3 years • The follow-up visits may be spaced up to 18 months apart. Participation in this study will involve completing physical, neurological, and cognitive examinations sufficient to complete the Alzheimer’s Disease Program Uniform Data Set (UDS), blood draws, and a brain MRI at baseline, and at annual follow-up visits 2 and 3. The de-identified data collected from the study will be shared with members of the Diverse VCID Consortium and other collaborating researchers for the study of vascular health and other conditions (e.g., Alzheimer’s disease, other forms of dementia, mental illness, HIV/AIDS, cancer, heart disease, and others). Recruitment into the study ends in March of 2024 and the final study will be concluded August 30, 2027.

Connect with a study center

  • Gulf Coast Alzheimer's Disease Research Center

    Mobile, Alabama 36688
    United States

    Active - Recruiting

  • University of California San Diego

    La Jolla, California 92093-0648
    United States

    Active - Recruiting

  • University of Southern California

    Los Angeles, California 900335310
    United States

    Active - Recruiting

  • University of California at Davis; Department of Neurology and Center for Neuroscience

    Sacramento, California 95817
    United States

    Active - Recruiting

  • Indiana University Alzheimer’s Disease Research Center

    Indianapolis, Indiana 46202
    United States

    Active - Recruiting

  • University of Kentucky

    Lexington, Kentucky 405042681
    United States

    Active - Recruiting

  • Johns Hopkins University

    Baltimore, Maryland 212242764
    United States

    Active - Recruiting

  • University of Michigan

    Ann Arbor, Michigan 48105
    United States

    Active - Recruiting

  • Columbia University

    New York, New York 10032
    United States

    Active - Recruiting

  • University of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Active - Recruiting

  • UTHealth Houston - Institute for Stroke and Cerebrovascular Diseases

    Houston, Texas 77030
    United States

    Active - Recruiting

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texas 78229
    United States

    Active - Recruiting

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