P75NTR, Diagnostic Biomarker for Alzheimer's Disease: Quantification Study in Cerebrospinal Fluid

Completed

• Conditions: Alzheimer Disease

• Registration Number: NCT02946710
• Lead Sponsor: University Hospital, Toulouse

Brief Summary

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.

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 Timeline

• Study Start: 2014-12
• Study First Submitted: 2016-07-07
• Study First Submitted QC: 2016-10-25
• Study First Posted: 2016-10-27
• Primary Completion: 2017-06
• Study Completion: 2017-12
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-02
• Last Update Posted: 2018-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Concentration of p75NTR-ECD total	Inclusion in the present study	Concentration of p75NTR-ECD total in CSF patients

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University Hospital of Toulouse; 🇫🇷 Toulouse, France