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Discovery of Novel Biomarkers That Will Lead to the Early Detection of Alzheimer's Disease (BVB)

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: NCT03136679
Recruitment Status : Recruiting
First Posted : May 2, 2017
Last Update Posted : October 7, 2019
Information provided by (Responsible Party):
Baylor Research Institute

Brief Summary:
This study will perform a targeted metabolic analysis in blood and urine samples from subjects attending the Baylor AT&T Memory Center. The aim is to identify novel biomarkers that can distinguish normal aging subjects with no cognitive impairment from those with mild, moderate or severe cognitive impairment associated with Alzheimer's disease. Subjects will also be screened for B-vitamin deficiencies that may correlate with other metabolic biomarkers and Alzheimer's disease.

Condition or disease
Mild Cognitive Impairment Alzheimer Disease

Detailed Description:

All subjects will be clinically assessed using standard measures of clinical care. Cognitive function will be assessed by the Montreal Cognitive Assessment (MoCA). Disease severity will be assessed by the Clinical Dementia Rating Scale (CDR). Social function will be assessed by the Functional Activities Questionnaire (FAQ). Based on clinical assessment, subjects will be classified into one of the following groups.

  1. Normal (Spouse or Caregiver)
  2. Mild cognitive impairment
  3. Alzheimer's disease A. Mild B. Moderate C. Severe

The investigators plan to enroll 60 subjects in each group from 1 and 2; 40 subjects in each of the groups 3A and 3B and 20 subjects in group 3C.

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Study Type : Observational
Estimated Enrollment : 220 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Discovery of Novel Biomarkers That Will Lead to the Early Detection of Alzheimer's Disease
Actual Study Start Date : March 22, 2017
Estimated Primary Completion Date : April 30, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

Group 1 Normal
Spouse or Subject's caregiver. Blood and urine samples will be collected.
Mild Cognitive Impairment
Subjects with MCI: Blood and urine samples will be collected.
Alzheimer's disease
Subjects with Alzheimer's disease A. Mild B. Moderate C. Severe Blood and urine samples will be collected from these three sub-groups.

Primary Outcome Measures :
  1. Discovery of novel biomarkers that will lead to the early detection of Alzheimer's disease. [ Time Frame: 6 months ]
    The primary goal of this proposal is to identify metabolic biomarkers in plasma and urine that can distinguish normal or mild cognitively impaired subjects from subjects at different severities of AD.

Biospecimen Retention:   Samples With DNA

All samples will be analyzed using a targeted metabolomic platform by liquid chromatography mass spectrometry (LC-MS). Further analysis will include determining 28 metabolite ratios from this data that will indicate activity of specific pathways. In addition, the investigators will analyze plasma samples for levels of vitamin B9 (folate), vitamin B12, vitamin B6, and several other metabolites related to methylation (8 metabolites).

DNA will be extracted from whole blood for genotyping of the following mutations using Taqman® SNP genotyping assays from Life Technologies. This analysis will include genotyping of ApoE4 and SNP's related to folate metabolism.

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
The investigators will aim to consent male and female subjects that are attending the Baylor AT&T Memory Center. Patients will be under the care of Dr. Cindy Marshall and Dr. Claudia Padilla.

Inclusion Criteria:

A. Both Males and females B. Patients at least 40-years of age C. Mild Cognitive Impairment D. Alzheimer 's disease

  1. Mild
  2. Moderate
  3. Severe

Exclusion Criteria:

A. No recent major surgery within the last 6 months B. Free of any malignant disease C. No chronic renal disease D. No other major neurodegenerative disorders (i.e. Parkinson's disease, multiple sclerosis)

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): NCT03136679

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Contact: Jocelyn A Allgood, RN, MS 214-818-0382

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United States, Texas
Baylor AT&T Memory Center Recruiting
Dallas, Texas, United States, 75231
Contact: Jocelyn A. Allgood, RN, MS    214-818-0382   
Principal Investigator: Claudia R Padilla, MD         
Sub-Investigator: Teodoro Bottiglieri, PhD         
Sponsors and Collaborators
Baylor Research Institute
Additional Information:

Publications of Results:
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Responsible Party: Baylor Research Institute Identifier: NCT03136679    
Other Study ID Numbers: 017-039
First Posted: May 2, 2017    Key Record Dates
Last Update Posted: October 7, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Alzheimer Disease
Cognitive Dysfunction
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cognition Disorders