Blood Biomarker of Alzheimer's Disease (AD)

Alzheimer Disease Clinical Trial

Official title:

mtDNA Damage in Alzheimer's Disease (AD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03340571
• Other study ID #: Pro00085997
• Status: Completed
• Start date: March 12, 2018
• Est. completion date: July 31, 2019

Study information

• Verified date: October 2019
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: July 31, 2019
• Est. primary completion date: July 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Alzheimer Disease

Locations

Country	Name	City	State
United States	Duke University	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biological marker of Alzheimer's disease	Test for blood biological marker of Alzheimer's disease, mtDNA damage	Day 1