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Amyloid Beta-peptide 1-40 and Alzheimer's Disease (ADAB40)

Primary Purpose

Alzheimer Disease

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
spinal fluid collection
Sponsored by
CHU de Reims
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Alzheimer Disease focused on measuring dementia, biomarkers, cerebrospinal fluid

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Chu de Reims

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

AD Patients

Arm Description

Outcomes

Primary Outcome Measures

Percentage of diagnostic certitude for AD (diagnosed cases)

Secondary Outcome Measures

Full Information

First Posted
March 31, 2015
Last Updated
June 18, 2020
Sponsor
CHU de Reims
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1. Study Identification

Unique Protocol Identification Number
NCT02770482
Brief Title
Amyloid Beta-peptide 1-40 and Alzheimer's Disease
Acronym
ADAB40
Official Title
Utility of Amyloid Beta-peptide 1-40 Measurement in the Diagnosis of Alzheimer's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
March 14, 2018 (Actual)
Study Completion Date
March 14, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CHU de Reims

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease
Keywords
dementia, biomarkers, cerebrospinal fluid

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
204 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AD Patients
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
spinal fluid collection
Primary Outcome Measure Information:
Title
Percentage of diagnostic certitude for AD (diagnosed cases)
Time Frame
six months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Chu de Reims
City
Reims
ZIP/Postal Code
51092
Country
France

12. IPD Sharing Statement

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Amyloid Beta-peptide 1-40 and Alzheimer's Disease

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