NCT02946710

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

July 7, 2016

Completed
4 months until next milestone

First Posted

Study publicly available on registry

October 27, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

April 3, 2018

Status Verified

April 1, 2018

Enrollment Period

2.5 years

First QC Date

July 7, 2016

Last Update Submit

April 2, 2018

Conditions

Alzheimer Disease

Keywords

Alzheimer diseaseAlzheimer's disease, biomarkersp75NTR-ECD

Outcome Measures

Primary Outcomes (1)

  • Concentration of p75NTR-ECD total

    Concentration of p75NTR-ECD total in CSF patients

    Inclusion in the present study

Secondary Outcomes (2)

  • Concentration of p75NTR-ECD bound to Aβ1-40 and Aβ1-42

    Inclusion in the present study

  • expression of p75NTR-ECD between patient groups

    inclusion in the present study

Interventions

cerebrospinal fluidBIOLOGICAL

Biological analysis on cerebrospinal fluid

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • patients with Parkinson disease or Lewy body dementia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Toulouse

Toulouse, France

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Delisle Marie-Bernadette, MD

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 7, 2016

First Posted

October 27, 2016

Study Start

December 1, 2014

Primary Completion

June 1, 2017

Study Completion

December 1, 2017

Last Updated

April 3, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)