NCT03621839

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
50,000

participants targeted

Target at P75+ for all trials

Timeline
300mo left

Started Jul 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress34%
Jul 2013Dec 2050

Study Start

First participant enrolled

July 12, 2013

Completed
5 years until next milestone

First Submitted

Initial submission to the registry

July 25, 2018

Completed
15 days until next milestone

First Posted

Study publicly available on registry

August 9, 2018

Completed
32.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2050

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2050

Last Updated

March 6, 2024

Status Verified

December 1, 2023

Enrollment Period

37.5 years

First QC Date

July 25, 2018

Last Update Submit

March 5, 2024

Conditions

Alzheimer DiseaseDementiaNeurodegenerative Diseases

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Absence of consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU De Nancy

Nancy, Grand Est, 54500, France

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

cerebrospinal fluid

MeSH Terms

Conditions

Alzheimer DiseaseDementiaNeurodegenerative Diseases

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurocognitive DisordersMental Disorders

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MCU-PH

Study Record Dates

First Submitted

July 25, 2018

First Posted

August 9, 2018

Study Start

July 12, 2013

Primary Completion (Estimated)

December 31, 2050

Study Completion (Estimated)

December 31, 2050

Last Updated

March 6, 2024

Record last verified: 2023-12

Locations

FR(1)