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

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ClinicalTrials.gov Identifier: NCT03136679
Recruitment Status : Unknown
Verified October 2019 by Baylor Research Institute.
Recruitment status was:  Recruiting
First Posted : May 2, 2017
Last Update Posted : October 7, 2019
Sponsor:
Information provided by (Responsible Party):
Baylor Research Institute

Tracking Information
First Submitted Date April 28, 2017
First Posted Date May 2, 2017
Last Update Posted Date October 7, 2019
Actual Study Start Date March 22, 2017
Estimated Primary Completion Date April 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 28, 2017)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Discovery of Novel Biomarkers That Will Lead to the Early Detection of Alzheimer's Disease
Official Title Discovery of Novel Biomarkers That Will Lead to the Early Detection of Alzheimer's Disease
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.
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
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:

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.

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.
Condition
  • Mild Cognitive Impairment
  • Alzheimer Disease
Intervention Not Provided
Study Groups/Cohorts
  • 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.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: April 28, 2017)
220
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2022
Estimated Primary Completion Date April 30, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria

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)

Sex/Gender
Sexes Eligible for Study: All
Ages 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03136679
Other Study ID Numbers 017-039
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Current Responsible Party Baylor Research Institute
Original Responsible Party Same as current
Current Study Sponsor Baylor Research Institute
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators Not Provided
PRS Account Baylor Research Institute
Verification Date October 2019