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

• ClinicalTrials.gov Identifier: NCT03136679
• Recruitment Status: Unknown
• First Posted: May 2, 2017
• Last Update Posted: October 7, 2019
• Sponsor: Baylor Research Institute
• 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
• 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 *

• 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.
• 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. Erratum In: J Am Geriatr Soc. 2019 Sep;67(9):1991.
• 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.

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

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