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

• Sponsor: CHU de Reims (Other)
• Overall Status: Completed
• CT.gov ID: NCT02770482
• Collaborator: (none)
• Enrollment: 204
• Location: 1
• Arm: 1
• Duration (Months): 45.4
• Patients Per Site Per Month: 4.5

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Alzheimer Disease	Biological: spinal fluid collection	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 204 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Utility of Amyloid Beta-peptide 1-40 Measurement in the Diagnosis of Alzheimer's Disease
• Study Start Date: Jun 1, 2014
• Actual Primary Completion Date: Mar 14, 2018
• Actual Study Completion Date: Mar 14, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: AD Patients	Biological: spinal fluid collection

Outcome Measures

Primary Outcome Measures

1. Percentage of diagnostic certitude for AD (diagnosed cases) [six months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chu de Reims	Reims		France	51092

Sponsors and Collaborators

• CHU de Reims

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: CHU de Reims
• ClinicalTrials.gov Identifier: NCT02770482
• Other Study ID Numbers: PA13050
• First Posted: May 12, 2016
• Last Update Posted: Jun 22, 2020
• Last Verified: Jun 1, 2020

• Keywords provided by CHU de Reims: dementia; biomarkers; cerebrospinal fluid
• Additional relevant MeSH terms: Alzheimer Disease

Study Results

No Results Posted as of Jun 22, 2020