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 : Recruiting
First Posted : May 2, 2017
Last Update Posted : October 7, 2019
|Condition or disease|
|Mild Cognitive Impairment Alzheimer Disease|
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.
- Normal (Spouse or Caregiver)
- Mild cognitive impairment
- 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|
|Estimated Enrollment :||220 participants|
|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|
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.
Subjects with Alzheimer's disease A. Mild B. Moderate C. Severe Blood and urine samples will be collected from these three sub-groups.
- 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.
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 ClinicalTrials.gov identifier (NCT number): NCT03136679
|Contact: Jocelyn A Allgood, RN, MSemail@example.com|
|United States, Texas|
|Baylor AT&T Memory Center||Recruiting|
|Dallas, Texas, United States, 75231|
|Contact: Jocelyn A. Allgood, RN, MS 214-818-0382 firstname.lastname@example.org|
|Principal Investigator: Claudia R Padilla, MD|
|Sub-Investigator: Teodoro Bottiglieri, PhD|