Blood Biomarker of Alzheimer's Disease (AD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03340571
Recruitment Status : Recruiting
First Posted : November 13, 2017
Last Update Posted : January 11, 2019
Information provided by (Responsible Party):
Duke University

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
Alzheimer Disease

Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: mtDNA Damage in Alzheimer's Disease (AD)
Actual Study Start Date : March 12, 2018
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine

Alzheimer's Patients
Healthy Volunteers

Primary Outcome Measures :
  1. Biological marker of Alzheimer's disease [ Time Frame: Day 1 ]
    Test for blood biological marker of Alzheimer's disease, mtDNA damage

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

The research coordinator(s) will review the clinic schedule in the Memory Disorders clinic at Duke University for potential patients who meet the basic inclusion/exclusion criteria who have appointments that day.

While consenting AD potential subjects, the study team may also ask their caregivers who accompany the AD patient to the clinic if they would also like to be part of the study and possibly enroll as a Healthy Control subject.


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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03340571

Contact: Kristina Balderson 919-684-0071

United States, North Carolina
Duke University Recruiting
Durham, North Carolina, United States, 27710
Contact: Kristina Balderson    919-684-0071   
Principal Investigator: Laurie Sanders, PhD         
Sponsors and Collaborators
Duke University
Principal Investigator: Laurie Sanders, PhD Assistant Professor

Responsible Party: Duke University Identifier: NCT03340571     History of Changes
Other Study ID Numbers: Pro00085997
First Posted: November 13, 2017    Key Record Dates
Last Update Posted: January 11, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
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

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders