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

Sponsor
Baylor Research Institute (Other)
Overall Status
Recruiting
CT.gov ID
NCT03136679
Collaborator
(none)
220
Enrollment
1
Location
69.3
Anticipated Duration (Months)
3.2
Patients Per Site Per Month

Study Details

Study Description

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 Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated 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 :
    Mar 22, 2017
    Anticipated Primary Completion Date :
    Apr 30, 2022
    Anticipated Study Completion Date :
    Dec 31, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

    1. Discovery of novel biomarkers that will lead to the early detection of Alzheimer's disease. [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    1. Both Males and females B. Patients at least 40-years of age C. Mild Cognitive Impairment
    2. Alzheimer 's disease

    1. Mild

    2. Moderate

    3. Severe

    Exclusion Criteria:
    1. 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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Baylor AT&T Memory Center Dallas Texas United States 75231

    Sponsors and Collaborators

    • Baylor Research Institute

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Baylor Research Institute
    ClinicalTrials.gov Identifier:
    NCT03136679
    Other Study ID Numbers:
    • 017-039
    First Posted:
    May 2, 2017
    Last Update Posted:
    Oct 7, 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
    Additional relevant MeSH terms:
    Alzheimer Disease
    Cognitive Dysfunction

    Study Results

    No Results Posted as of Oct 7, 2019