NCT02770482

Brief Summary

The combined measurement of Ab42 and tau protein (total and phosphorylated) in the spinal fluid has been shown to be promising in the diagnosis of Alzheimer's disease (AD), and has justified its inclusion new diagnostic criteria. However, it can sometimes yield discordant results that are not discriminant (isolated variation in Ab42 or P-181 Tau). To answer this challenge, a new marker has been developed in recent years, namely amyloid beta-peptide 1-40 (Aβ40). This marker reflects the patient's total amyloid deposits and is used to calculate the Aβ42/Aβ40 ratio. This ratio measures the relative variation of Aβ42 as compared to the total amyloid burden. Literature data on this topic are sparse and to date, no report has been published evaluating the utility of this marker in the diagnostic strategy for AD.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
204

participants targeted

Target at P75+ for not_applicable alzheimer-disease

Timeline
Completed

Started Jun 2014

Typical duration for not_applicable alzheimer-disease

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

June 1, 2014

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

March 31, 2015

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

May 12, 2016

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 14, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 14, 2018

Completed
Last Updated

January 21, 2026

Status Verified

June 1, 2020

Enrollment Period

3.8 years

First QC Date

March 31, 2015

Last Update Submit

January 19, 2026

Conditions

Alzheimer Disease

Keywords

dementiabiomarkerscerebrospinal fluid

Outcome Measures

Primary Outcomes (1)

  • Percentage of diagnostic certitude for AD (diagnosed cases)

    six months

Study Arms (1)

AD Patients

EXPERIMENTAL
Biological: spinal fluid collection

Interventions

spinal fluid collectionBIOLOGICAL
AD Patients

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients attending the Memory Clinic of Champagne-Ardennes for memory disorders, and

You may not qualify if:

  • Patients who do not have any social security coverage will not be included.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu de Reims

Reims, 51092, France

Location

Related Publications (1)

  • Kisserli A, Tabary T, Cohen JHM, Duret V, Mahmoudi R. High-resolution Melting PCR for Complement Receptor 1 Length Polymorphism Genotyping: An Innovative Tool for Alzheimer's Disease Gene Susceptibility Assessment. J Vis Exp. 2017 Jul 18;(125):56012. doi: 10.3791/56012.

    PMID: 28745649BACKGROUND

MeSH Terms

Conditions

Alzheimer DiseaseDementia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2015

First Posted

May 12, 2016

Study Start

June 1, 2014

Primary Completion

March 14, 2018

Study Completion

March 14, 2018

Last Updated

January 21, 2026

Record last verified: 2020-06

Locations

FR(1)