P75NTR, Diagnostic Biomarker for Alzheimer's Disease: Quantification Study in Cerebrospinal Fluid (P75NTR-MND)

April 2, 2018 updated by: University Hospital, Toulouse
This research will be achieved by the assessment of p75NTR-ECD expression (total and linked to different species of Aβ (Aβ1-40 and Aβ-1-42)) within the cerebrospinal fluid (CSF) of patients with AD dementia, mild cognitive impairment (MCI) due to AD, frontotemporal dementia and non-neurodegenerative dementia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Alzheimer's disease (AD) is a dementia which is clinically characterized by cognitive impairments with early memory loss and neuropathologically by two main lesions, amyloid deposits and tau protein accumulation. Presently, early diagnosis of AD relies on clinical symptoms, imaging techniques with recently introduced radio-tracers and analysis of cerebrospinal fluid biomarkers. All these tools are efficient when patients are already symptomatic and it is presently known that the lesions that might be reversible appear early in the time life of patients, several decades before the onset of clinical signs. To find a biomarker which would be detected early and tested in peripheral fluids is our challenge. According to updated physiopathology of the disease and referring to previous work on sphingolipid pathway in AD, precedent study focused attention on an original protein, p75NTR and particularly its extracellular domain (ECD). This protein is involved in the physiopathology of AD in several ways (apoptosis, survival). P75NTR-ECD interacts with Aβ, increases its solubility and accelerates its clearance.

The hypothesis of the present study is that p75NTR-ECD could be expressed differentially according to the category and stage of dementia. More precisely, this new biomarker could help for the diagnosis of AD and could also be used as an early marker of AD when tested in peripheral fluid.

Study Type

Observational

Enrollment (Actual)

120

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

  • France
      • Toulouse, France
        • University Hospital of Toulouse

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

40 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

CSF from patients with AD, patients with MCI due to AD, patients with frontotemporal dementia and patients with non-neurodegenerative dementia. Inclusion criteria according to Diagnostic and Statistical Manual-V (DSM-V) and updated NIA recommendations.

Description

Inclusion Criteria:

  • patients with AD
  • patients with MCI due to AD,
  • patients with frontotemporal dementia
  • patients with non-neurodegenerative dementia, according to DSM-V and updated National Institute on Aging (NIA) recommendations

Exclusion Criteria:

  • patients with Parkinson disease or Lewy body dementia

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
Concentration of p75NTR-ECD total
Time Frame: Inclusion in the present study
Concentration of p75NTR-ECD total in CSF patients
Inclusion in the present study

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Concentration of p75NTR-ECD bound to Aβ1-40 and Aβ1-42
Time Frame: Inclusion in the present study
detection in CSF from patients
Inclusion in the present study
expression of p75NTR-ECD between patient groups
Time Frame: inclusion in the present study
Differential expression of p75NTR-ECD between patient groups. Diagnostic and prognostic potential of p75NTR-ECD quantification.
inclusion in the present study

Collaborators and Investigators

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

Sponsor

University Hospital, Toulouse

Investigators

  • Principal Investigator: Delisle Marie-Bernadette, MD, University Hospital, Toulouse

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)

December 1, 2014

Primary Completion (ACTUAL)

June 1, 2017

Study Completion (ACTUAL)

December 1, 2017

Study Registration Dates

First Submitted

July 7, 2016

First Submitted That Met QC Criteria

October 25, 2016

First Posted (ESTIMATE)

October 27, 2016

Study Record Updates

Last Update Posted (ACTUAL)

April 3, 2018

Last Update Submitted That Met QC Criteria

April 2, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14 7317 02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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