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

January 22, 2026 updated by: Baylor Research Institute
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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

95

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75231
        • Baylor AT&T Memory Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

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.

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baylor Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 22, 2011

Primary Completion (Actual)

November 24, 2021

Study Completion (Actual)

November 24, 2021

Study Registration Dates

First Submitted

April 28, 2017

First Submitted That Met QC Criteria

April 28, 2017

First Posted (Actual)

May 2, 2017

Study Record Updates

Last Update Posted (Actual)

January 26, 2026

Last Update Submitted That Met QC Criteria

January 22, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 017-039

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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