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Alzheimer Biomarkers on CSF of Elderly Patients Undergoing Surgery

NCT03977025 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2019-06-13

No results posted yet for this study

Summary

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.

Conditions

  • Alzheimer Disease

Interventions

DIAGNOSTIC_TEST

Lumbar punction

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 lumbar punction, will be analyzed by immunodetection of Aβ40, Aβ42, tau and ptau with multiplex technology

Sponsors & Collaborators

  • University of Chile

    lead OTHER

Principal Investigators

  • Sergio Vera, MD · University of Chile

Eligibility

Min Age
65 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-06-11
Primary Completion
2019-09-30
Completion
2020-03-31

Countries

  • Chile

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03977025 on ClinicalTrials.gov