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

Baylor Scott and White Health (BSWH)

Status: Completed

Conditions: Alzheimer Disease; Mild Cognitive Impairment

Study type: Observational

Funder types: Other

Identifiers

NCT03136679

017-039

Details and patient eligibility

About

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.

Full 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.

Enrollment: 95 patients

Sex: All

Ages: 40+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

95 participants in 3 patient groups

Group 1 Normal

Description:

Spouse or Subject's caregiver. Blood and urine samples will be collected.

Mild Cognitive Impairment

Description:

Subjects with MCI: Blood and urine samples will be collected.

Alzheimer's disease

Description:

Subjects with Alzheimer's disease A. Mild B. Moderate C. Severe Blood and urine samples will be collected from these three sub-groups.