Relationship Between Protein Biomarkers in Cerebrospinal Fluid and Alzheimer&Apos;s Disease in Patients With Depression (LIDEAL)

October 5, 2018 updated by: Institut Investigacio Sanitaria Pere Virgili

Study of the Relationship Between Protein Biomarkers in Cerebrospinal Fluid and the Risk of Progression to Alzheimer&Apos;s Disease in a Cohort of Patients With Depression

It is currently accepted that depression during midlife is a risk factor for Alzheimer's disease (AD). Furthermore, several prospective population studies have demonstrated that depression is an independent risk factor for incident dementia of different types (e.g. vascular, mixed, Alzheimer's disease). However, it is not clear, what are the mechanisms that link depression and dementia, and if depression can be a prodromal manifestation of AD. There are also studies that suggest that depression could be an initial sign of AD.

Objective:

  1. Demonstrate that late life depression (over 60 years of age) constitutes the first manifestation of AD.
  2. Define by rating scales and life stressors have differential risk profiles evolutionary AD.
  3. To study the relationship between the subtypes of depression and CSF biomarkers, neurophycological test and evolution to AD.

Study Overview

Status

Terminated

Conditions

Detailed Description

Groups of subjects: patients with recent apparition of late life depression without fulfilling the dementia criteria (Global Deterioration Scale, GDS, stages 1, 2 and 3). A longitudinal, prospective population study with two years follow-up. A cohort of will be included in the study. The patient's depression will be defined and categorized according to its severity (Yesavage Scale), whether it's endogenous or reactive (Holmes and Rahe scale) and taking into account the patient's medical history of depression.

There will be a prospective follow-up of conversion to dementia (starting from GDS Stage 4). It will be considered that dementia corresponds to AD if the biological markers of LCR present typical changes of AD at the moment of inclusion (Beta amyloid low and P-tau high).

It will be studied if there's any correlation between the clinically defined depression types and a high risk of progression to dementia and especially to AD.

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

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

Study Locations

  • Spain
    • Tarragona
      • Tortosa, Tarragona, Spain, 43500
        • Hospital de Tortosa, Verge de la Cinta

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

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Consecutive patients referred from Primary Care and Psychiatry, Neurology with consultations for specialist for cognitive impairment and / or depression who met the inclusion criteria of the study assessment.

Description

Inclusion Criteria:

  • >= 60 years.
  • GDS (Reisberg Gobal Dementia Scale) of 2 to 3.
  • Geriatric Depression Scale of Yesavage >=12.
  • History of previous depressive episodes resolved, but the emotional situation 15 months before inclusion, necessarily have to be normal.

Exclusion Criteria:

  • Established dementia of any cause, or secondary degenerative dementia of any origin
  • Primary diagnosis of cognitive impairment with psychiatric illness (schizophrenia , bipolar disorder, personality disorders ... )
  • Dual diagnosis of chronic depression, dysthymia more than 15 months duration, or major depression with psychotic or atypical symptoms
  • Neuroimaging with significant chronic vascular involvement
  • To take drugs with known side effects on cognition and it is suspected that the neuropsychological deficits.
  • Moderate or severe sensory deprivation or functional illiteracy in the neuropsychological study can not be performed
  • Neoplastic diseasesContraindication to performing a lumbar puncture

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
Analysis of cerebrospinal fluid
Time Frame: between the second and the fifth day after inclusion visit
Measure alterations in amyloid AB 1-42, total tau protein and phosphorylated tau protein, in pg/ml. Those alterations will be correlated with the evolution to dementia at final visit (after 24 months +/- 5 days)
between the second and the fifth day after inclusion visit

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Conversion to dementia
Time Frame: first measure at inclusion visit and second measure at final visit (after 24 months +- 5 days).
Measure increases scores in Global Dementia Scale (GDS), considering no dementia GDS from 1 until 3, and evolution to dementia GDS form 3 until 6
first measure at inclusion visit and second measure at final visit (after 24 months +- 5 days).
Depression subtypes
Time Frame: at basal visit

classify the type of depression by scores in two scales. One of them is Yesavage with scores between 11-17 corresponding with "low depression" and scores between 18-30 with "major depression". the second ones is Vital Stressors Scale of Holmes and Rahe which define adaptative depression as scores upper than 150 and non adaptative depression as scores between 0 and 150.

Subtype of depression will be correlated with posterior evolution to dementia at final visit (after 24 months +/- 5 days)
at basal visit

Collaborators and Investigators

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

Sponsor

Institut Investigacio Sanitaria Pere Virgili

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)

January 1, 2014

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

October 1, 2018

Study Registration Dates

First Submitted

May 30, 2014

First Submitted That Met QC Criteria

November 24, 2014

First Posted (Estimate)

November 27, 2014

Study Record Updates

Last Update Posted (Actual)

October 9, 2018

Last Update Submitted That Met QC Criteria

October 5, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IISPV-LIDEAL-HTVC

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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