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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02770482
Other study ID # PA13050
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 2014
Est. completion date March 14, 2018

Study information

Verified date June 2020
Source CHU de Reims
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 204
Est. completion date March 14, 2018
Est. primary completion date March 14, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

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

- Whose diagnostic work-up requires assessment of biomarkers present in the cerebrospinal fluid are considered eligible for inclusion in this study.

Exclusion Criteria:

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

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
spinal fluid collection


Locations

Country Name City State
France Chu de Reims Reims

Sponsors (1)

Lead Sponsor Collaborator
CHU de Reims

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of diagnostic certitude for AD (diagnosed cases) six months
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