Alzheimer Biomarkers on CSF of Elderly Patients Undergoing Surgery

June 11, 2019 updated by: Sergio Vera, University of Chile

Evaluation of Alzheimer's Biomarkers in Cerebrospinal Fluid and Peripheral Blood of Elderly Patients Undergoing Surgery in the HCUCH.

Dementia is a syndrome characterized by cognitive and behavioral impairment in older adults, which usually manifests as memory loss, communication difficulties or changes in mood. Dementias affect around 50 million people in the world, having an impact on their ability to carry out their daily activities, often requiring family and social support.

The main cause of dementia in Chile and in the world is Alzheimer's disease (AD), which is characterized by affecting large areas of the cerebral cortex and hippocampus, manifesting mainly in alterations in selective memory. The pathogenesis of AD involves the neuronal accumulation of β-amyloid (Aβ) proteins in the form of extracellular plaques, and tau, which gives rise to neurofibrillary tangles. AD diagnosis is usually made based on clinical criteria, however, the accurate diagnosis of AD is clinical-neuropathological. Several studies have supported the neuropathological study based on the presence of Aβ and tau proteins in cerebrospinal fluid (CSF), using them as biomarkers of the disease, which has allowed updating the definition of AD based on them. However, our country does not perform a study of dementia biomarkers in CSF, which is essential for the diagnosis of certainty of the pathology.

The objective of this project is to evaluate a set of biomarkers of EA (tau, ptau, Aβ) in CSF and blood of elderly patients who will undergo surgery in the Clinical Hospital of the University of Chile (HCUCH) and in whom it is performed lumbar puncture (LP) by anesthesia, to detect those patients who have these CSF biomarkers and who show lower performance in cognitive evaluations. For this, it is intended to mount a biobank of CSF samples with samples of 30 subjects by conducting a clinical pilot study. Patients will be evaluated prior to surgery with the Montreal Cognitive Assessment (MoCA) to determine the presence of cognitive impairment, and CSF samples, obtained by LP, will be analyzed by immunodetection of Aβ40, Aβ42, tau and ptau with multiplex technology. In addition, tau will be detected in platelets by Western Blot of blood samples from patients, and the relationship between plateau tau levels and biomarkers in CSF will be evaluated. Finally, the correlation between performance in cognitive assessment and levels of biomarkers in blood and CSF will be evaluated, in order to assess the usefulness of these markers in the detection of the presence of cognitive impairment.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Chile
      • Santiago, Chile
        • Recruiting
        • University of Chile Clinical Hospital
        • Contact:
          • Sergio Vera, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years to 99 years (Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients who will undergo surgery in the HCUCH, for any reason

Description

Inclusion Criteria:

  • Subjects older than 65 years who will undergo surgery in the HCUCH (for any reason) and who require lumbar puncture for anesthesia.
  • Autovalent, with no history of dementia, with MoCA ≥ 20 points (score adapted to the Chilean population).
  • The subjects will not be carriers of medical, neurological or psychiatric pathologies that could affect their participation in the study or its results. The presence of chronic pathologies will be admitted, as long as they are under stable treatment and without evidence of decompensation in the last 3 months.

Exclusion Criteria:

  • Antecedents of being carriers of dementia or symptomatic neurodegenerative disease.
  • Medical or surgical decompensated pathology.
  • Contraindication of lumbar puncture.
  • Physical or mental inability to consent to study entry.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Montreal Cognitive Assessment
Time Frame: 1 day
Correlate the degree of cognitive deterioration obtained in the MOCA evaluation with the levels of biomarkers in CSF and blood.
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Chile

Investigators

  • Principal Investigator: Sergio Vera, MD, University of Chile

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 11, 2019

Primary Completion (Anticipated)

September 1, 2019

Study Completion (Anticipated)

March 1, 2020

Study Registration Dates

First Submitted

June 4, 2019

First Submitted That Met QC Criteria

June 4, 2019

First Posted (Actual)

June 6, 2019

Study Record Updates

Last Update Posted (Actual)

June 13, 2019

Last Update Submitted That Met QC Criteria

June 11, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Saval 018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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