New CSF Biomarkers for Alzheimer's Disease | NCT03621839

Studies
New CSF Biomarkers for Alzheimer's Disease

NCT03621839

Sponsor

Central Hospital, Nancy, France

Status

Recruiting

Last Update Posted

Mar 6, 2024Actual

Enrollment

50,000Estimated

Phase

Not provided

Conditions

Alzheimer Disease
Dementia
Neurodegenerative Diseases

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2023

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 12, 2013Actual

Primary Completion Date

Dec 31, 2050Estimated

Completion Date

Dec 31, 2050Estimated

First Submitted Date

Jul 25, 2018

First Submission Date that Met QC Criteria

Aug 3, 2018

First Posted Date

Aug 9, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 5, 2024

Last Update Posted Date

Mar 6, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Today, the Alzheimer's disease (AD) diagnosis is founded not only on clinical criteria but also on complementary examinations to confirm a physiopathological process of AD. In complex cases, lumbar punction could be necessary in order to measure Aβ peptides and Total and phosphorylated Tau but new biomarkers could be useful. The main objective of this project is to conserve these cerebrospinal fluids, collected in usual practice in order to validate new biomarkers for diagnosis, prognosis or therapeutic following of Alzheimer's disease and other dementia.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

50,000Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
CSF collection constitution to have samples available for assessing new Alzheimer's biomarker	Each CSF collected in the context of dementia diagnosis were conserved to be used in other studies on Alzheimer's or dementia biomarkers. Futre studies that will use collected CSF to assess new biomarkers will be conduced under a new protocol describing scientific contexte, specific aims and time frame necessary to achieve them.	50 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Lumbar punction collected in usual practice in the context of dementia diagnosis

Exclusion Criteria:

Absence of consent

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

All consenting patients submitted to a lumbar punction in the context of dementia diagnosis

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHRU De Nancy	Recruiting	Nancy	Grand Est	54500	France

Condition Browse Module

MeSH Terms

ID	Term
D000544	Alzheimer Disease
D003704	Dementia
D019636	Neurodegenerative Diseases

Ancestor Terms

ID	Term
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D024801	Tauopathies

Browse Leaves

Not provided

Browse Branches

Not provided