Alzheimer DiseaseBioADNCT03621839
New CSF Biomarkers for Alzheimer's Disease
An observational study of Alzheimer Disease and Dementia, run by Central Hospital, Nancy, France at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Alzheimer Disease, Dementia, Neurodegenerative Diseases
- How many people
- 50,000 participants
- Where
- 1 siteFrance
- Study dates
- 12 Jul 2013to 31 Dec 2050
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All consenting patients submitted to a lumbar punction in the context of dementia diagnosis
Who may be able to join
- Lumbar punction collected in usual practice in the context of dementia diagnosis
Who cannot join
- Absence of consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHRU De Nancy
Nancy, Grand Est, 54500
Catherine MALAPLATE, c.armand@chru-nancy.fr
About this study
Official title: New Diagnosis or Prognosis Biomarkers for Alzheimer's Disease: Biobank of CSF Collected as Part of Differential Diagnosis of Dementia
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.
- Conditions
- Alzheimer Disease, Dementia, Neurodegenerative Diseases
- Medical subject headings
- Alzheimer Disease, Dementia, Neurodegenerative Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 50 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2018
- Study start12 Jul 2013
- Primary completion31 Dec 2050 (estimated)
- Study completion31 Dec 2050 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Catherine MALAPLATE, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03621839
- Sponsor's protocol ID
- 2012-PSS/COLL- LCR/ARMAND/MS
- Acronym
- BioAD
- Status last verified
- Dec 2023
- First submitted
- 25 Jul 2018
- Last updated
- 6 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Diagnosis or Prognosis Biomarkers for Alzheimer's Disease: Biobank of CSF Collected as Part of Differential Diagnosis of Dementia
- ClinicalTrials.gov ID
- NCT03621839
- Acronym / sponsor ID
- BioAD / 2012-PSS/COLL- LCR/ARMAND/MS
- Conditions
- Alzheimer Disease, Dementia, Neurodegenerative Diseases
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50,000 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 12 Jul 2013 (actual)
- Primary completion
- 31 Dec 2050 (estimated)
- Study completion
- 31 Dec 2050 (estimated)
- First posted
- 9 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All consenting patients submitted to a lumbar punction in the context of dementia diagnosis
Key inclusion criteria (1 listed)
- Lumbar punction collected in usual practice in the context of dementia diagnosis
Key exclusion criteria (1 listed)
- Absence of consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
CSF collection constitution to have samples available for assessing new Alzheimer's biomarker
Time frame: 50 years
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer Disease and Dementia, run by Central Hospital, Nancy, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CSF collection constitution to have samples available for assessing new Alzheimer's biomarker (time frame: 50 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2024.