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Genetic Studies in Familial Dementia

Sponsor
University of Miami (Other)
Overall Status
Recruiting
CT.gov ID
NCT04680013
Collaborator
Case Western Reserve University (Other), Columbia University (Other), Wake Forest University (Other), National Institute on Aging (NIA) (NIH)
20,000
Enrollment
1
Location
221
Anticipated Duration (Months)
90.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to identify genetic factors that contribute to or cause dementia (loss of memory) and related disorders across all ages and ethnic groups. This includes a number of neurological diseases such as early and late-onset Alzheimer disease, mild cognitive impairment, and other dementias.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    20000 participants
    Observational Model:
    Other
    Time Perspective:
    Retrospective
    Official Title:
    Genetic Studies in Familial Dementia
    Actual Study Start Date :
    Jun 1, 2007
    Anticipated Primary Completion Date :
    Nov 1, 2025
    Anticipated Study Completion Date :
    Nov 1, 2025

    Arms and Interventions

    Arm Intervention/Treatment
    Cognitive Control

    Participants in this group are cognitively intact.
    Mild Cognitive Impairment

    Participants in this group have mild cognitive impairment.
    Dementia Group

    Participants in this group have dementia.

    Outcome Measures

    Primary Outcome Measures

    1. Correlation between genetic factors and Alzheimer disease, dementia, and related phenotypes. [5 years]

      Genetic factors will be measured through genome-wide genotyping arrays and/or whole-genome sequencing, and then correlated with Alzheimer disease and related phenotypes, such as cognitive impairment, functional impairment, and relevant biomarkers. .

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    1. 18 years and older

    2. Patients diagnosed with dementia, their family members and unrelated healthy controls without dementia.

    Exclusion Criteria:
    1. Individuals with competing diagnosis such as: Amyotrophic lateral sclerosis, Frontotemporal lobar degeneration, Multiple system atrophy, Corticobasal degeneration, Progressive Supranuclear Palsy, Huntington's disease, traumatic brain injury, drug or alcohol abuse, or schizophrenia, etc. (unless family members of a dementia affected individual).

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Miami Miami Florida United States 33136

    Sponsors and Collaborators

    • University of Miami
    • Case Western Reserve University
    • Columbia University
    • Wake Forest University
    • National Institute on Aging (NIA)

    Investigators

    • Principal Investigator: Margaret Pericak-Vance, PhD, University of Miami

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Margaret Pericak-Vance, Professor, University of Miami
    ClinicalTrials.gov Identifier:
    NCT04680013
    Other Study ID Numbers:
    • 20070307
    • RF1AG054080
    • RF1AG054074
    • U01AG052410
    First Posted:
    Dec 22, 2020
    Last Update Posted:
    Aug 30, 2021
    Last Verified:
    Aug 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Margaret Pericak-Vance, Professor, University of Miami
    Memory loss
    Additional relevant MeSH terms:
    Alzheimer Disease
    Dementia
    Late Onset Disorders
    Cognitive Dysfunction

    Study Results

    No Results Posted as of Aug 30, 2021