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

Alzheimer Disease Clinical Trial

— BVB  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03136679
• Other study ID #: 017-039
• Status: Recruiting
• Start date: March 22, 2017
• Est. completion date: December 31, 2022

Study information

• Verified date: October 2019
• Source: Baylor Research Institute
• Contact: Jocelyn A Allgood, RN, MS
• Phone: 214-818-0382
• Email: jocelyn.allgood[@]bswhealth.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 220
• Est. completion date: December 31, 2022
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Alzheimer Disease
• Cognitive Dysfunction
• Mild Cognitive Impairment

Locations

Country	Name	City	State
United States	Baylor AT&T Memory Center	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Baylor Research Institute

Country where clinical trial is conducted

United States, 

References & 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 — View Citation

Nasreddine ZS, Phillips NA, Bédirian 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. Erratum in: J Am — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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