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

NCT03136679 | Completed

• 1 other identifier: 017-039
• Study Type: observational
• Target: 95
• Locations: 1 country
• Sites: 1

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.

Conditions

Mild Cognitive Impairment; Alzheimer Disease

Outcome Measures

Primary Outcomes (1)

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

  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

Study Arms (3)

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.

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Baylor Research Institute: lead

Study Sites (1)

Baylor AT&T Memory Center

Dallas, Texas, 75231, United States

Location

Related Publications (3)

• Aisen PS, Schneider LS, Sano M, Diaz-Arrastia R, van Dyck CH, Weiner MF, Bottiglieri T, Jin S, Stokes KT, Thomas RG, Thal LJ; Alzheimer Disease Cooperative Study. High-dose B vitamin supplementation and cognitive decline in Alzheimer disease: a randomized controlled trial. JAMA. 2008 Oct 15;300(15):1774-83. doi: 10.1001/jama.300.15.1774.

  PMID: 18854539 RESULT

• Nasreddine ZS, Phillips NA, Bedirian V, Charbonneau S, Whitehead V, Collin I, Cummings JL, Chertkow H. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005 Apr;53(4):695-9. doi: 10.1111/j.1532-5415.2005.53221.x.

  PMID: 15817019 RESULT

• Pfeffer RI, Kurosaki TT, Harrah CH Jr, Chance JM, Filos S. Measurement of functional activities in older adults in the community. J Gerontol. 1982 May;37(3):323-9. doi: 10.1093/geronj/37.3.323.

  PMID: 7069156 RESULT

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.

MeSH Terms

Conditions

Cognitive Dysfunction; Alzheimer Disease

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2017
• First Posted: May 2, 2017
• Study Start: March 22, 2011
• Primary Completion: November 24, 2021
• Study Completion: November 24, 2021
• Last Updated: January 26, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)