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Blood Biomarker of Alzheimer's Disease (AD)

Sponsor
Duke University (Other)
Overall Status
Completed
CT.gov ID
NCT03340571
Collaborator
(none)
21
Enrollment
1
Location
16.6
Actual Duration (Months)
1.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Currently, no cures or disease modifying therapies exist for Alzheimer's disease (AD). This is partially due to the inability to detect the disease before it has progressed to a stage where there are clinical manifestations. The identification and validation of high throughput biomarkers to measure disease progression (as well as identify pre-clinical disease onset) is critical to the development of disease-modifying or even preventative therapies. In this study, we are testing a blood biomarker for stratification of Alzheimer's disease patients and healthy volunteers. This study may lead to future blood tests that may help earlier diagnosis of Alzheimer's disease and detect the disease progression.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    21 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    mtDNA Damage in Alzheimer's Disease (AD)
    Actual Study Start Date :
    Mar 12, 2018
    Actual Primary Completion Date :
    Jul 31, 2019
    Actual Study Completion Date :
    Jul 31, 2019

    Arms and Interventions

    Arm Intervention/Treatment
    Alzheimer's Patients
    Healthy Volunteers

    Outcome Measures

    Primary Outcome Measures

    1. Biological marker of Alzheimer's disease [Day 1]

      Test for blood biological marker of Alzheimer's disease, mtDNA damage

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    Alzheimer's Disease Patients:

    • 50 years and older

    • AD patient who is seen at the Memory Disorders Clinic

    • AD diagnosis

    • Non smoking

    • No cancer treatment in the last 5 years

    • Informed consent from the patient or the patient's legally authorized representative (LAR)

    • Patient and/or LAR able to read and speak English

    Healthy Control Participants:

    • 50 years and older

    • Non smoking

    • No cancer treatment in the last 5 years

    • Age matched to AD subject

    • Able to read and speak English

    Exclusion Criteria:
    Alzheimer's Disease Patients:
    • Known additional neurological disease
    Healthy Control Participants:
    • Neurological degenerative diseases (such as Parkinson's, Alzheimer's or Huntington's)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Duke University Durham North Carolina United States 27710

    Sponsors and Collaborators

    • Duke University

    Investigators

    • Principal Investigator: Laurie Sanders, PhD, Assistant Professor

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Duke University
    ClinicalTrials.gov Identifier:
    NCT03340571
    Other Study ID Numbers:
    • Pro00085997
    First Posted:
    Nov 13, 2017
    Last Update Posted:
    Oct 23, 2019
    Last Verified:
    Oct 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Duke University
    Alzheimer's Disease
    biomarkers
    blood
    Additional relevant MeSH terms:
    Alzheimer Disease

    Study Results

    No Results Posted as of Oct 23, 2019