Alzheimer DiseaseECTAUSOMENCT03381482
Ectosomes, New Biomarkers of Tau Pathology?
An observational study of Alzheimer Disease, run by University Hospital, Lille at 1 site in France.
Trial summary
In Alzheimer's disease (AD), neurofibrillary degeneration (NFD) is characterized by the intraneuronal aggregation of Tau proteins. The pathology progresses through a hierarchical pathway that may be associated with the intercellular transmission of pathology as demonstrated in our rat models. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- CSF drawing during spinal anaesthesia, Fasting blood sample and Lumbar puncture
- How many people
- 71 participants
- Where
- 1 siteFrance
- Study dates
- 20 Dec 2017to 23 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects intended to participate in group 1 have to undergo a lumbar puncture for other reasons than a cognitive complaint. They will be identified in the anaesthesiology department among patients who are waiting for scheduled orthopaedic surgery needing spinal anaesthesia. They will have the sample collection done with its specific procedures in the same time. if a subject is already followed at the MRRC and meets group 1 eligibility criteria, he/she could be asked to participate in the study and thus be enrolled and followed by a MRRC investigator. Patients intended to participate in groups 2 to 5 will be identified at the MRRC during their scheduled visit with the investigators specialized in neurology/geriatric medicine.
Who may be able to join
- Subjects able to undergo a lumbar puncture;
- Subjects who have a partner who will be required for driving back the subject after the lumbar punction for safety reasons (not required for control subjects);
- Subjects (or the study partner for group 5) capable of and willing to comply with the protocol and to give their written informed consents after having received and understood the subject information. According to the legal protection or the mental capacities of the subject, he/she will be accompanied by him/her legally acceptable representative during this procedure;
- Blood coagulation testing
- Subjects registered with the French Social Security, in agreement with the French law on biomedical experimentation.
- Group 1: controls
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- absence of cognitive complaint
- absence of significant cognitive impairment: MMSE>27
- Negative ApoE4 status (ε 4-/ ε 4-) No family history of AD at first degree Group 2: asymptomatic cases with high risk to develop AD
- absence of cognitive complaint
- absence of significant cognitive impairment : MMSE>27
- known ApoE4 status or family history of AD at first degree Group 3: cases with isolated cognitive complaint
- presence of a cognitive complaint
- absence of cognitive impairment assessed by MMSE>27 and standard neuropsychological examination (performed < 1 year) Group 4: prodromal AD according to the 2007 criteria (Dubois et al., 2007)
- progressive and significant episodic memory impairment >6 months
- And at least one of the following: medial temporal atrophy of brain MRI / low Ab42 and increased total and phosphorylated Tau protein in the CSF/ bilateral temporoparietal hypometabolism on brain FDG-PET/ positive amyloid brain PET if available
- exclusion of any differential diagnoses Group 5: Mild to moderate probable AD-type dementia according to the NIA 2011 criteria
- progressive and significant cognitive decline >6 months
- amnestic or any other predominant clinical presentation
Who cannot join
- MMSE between 15 and 26 (inclusive)
- Subjects with dementia caused by a non-neurodegenerative disease, including patients with severe cerebrovascular risk factor load;
- Associated Illnesses or conditions:
- Subjects with other neurodegenerative disease such as fronto-temporal dementia (FTD), Lewy body dementia and Parkinson's disease;
- Subjects with other serious neurological disorder such as brain tumour, stroke, epilepsy, hydrocephalus and any condition which contraindicates, in the investigator's judgment, entry to the study;
- Subjects with demyelinating diseases of the peripheral nervous system such as Guillain-Barre Syndrome;
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- Biological exclusion criteria:
- Subjects with known active Hepatitis C Virus (HCV), Hepatitis B Virus (HBV) or Human Immunodeficiency Virus (HIV);
- Subjects with clinical or significant laboratory abnormalities, in the judgment of the investigator;
- Others:
- Subjects with excessive alcohol intake or drug abuse, in the judgment of the investigator;
- Subjects who have contraindications to perform a lumbar puncture;
- Subjects who, in the opinion of the Investigator, have a risk of non-compliance to the study procedures or who are otherwise not appropriate to include in this clinical trial (for example, being impossible to contact in case of emergency).
Trial locations and contacts
1 site in 1 country.
About this study
In Alzheimer's disease (AD), neurofibrillary degeneration (NFD) is characterized by the intraneuronal aggregation of Tau proteins. The pathology progresses through a hierarchical pathway that may be associated with the intercellular transmission of pathology as demonstrated in our rat models. This transmission implies that Tau is actively secreted and may participate to the first steps of Tau pathology spreading. It is demonstrated in cell lines and animal models (rodents and non-human primates) that Tau is secreted not only in free forms but also in extracellular vesicles. If Tau is found in biological fluids before neuronal death it may represent an early marker of the NFD and will also define therapeutically targets. In this context, the aim is now to transfer this knowledge in humans and to decipher the nature of Tau secreted in plasma and cerebrospinal fluids collected from healthy controls to AD patients, and to decipher if the presence of tau inside vesicles is influenced by the pathology.
- Conditions
- Alzheimer Disease
- Being tested
- CSF drawing during spinal anaesthesia, Fasting blood sample, Lumbar puncture
- Keywords
- Alzheimer disease, Extracellular vesicles, Biomarker, Tau, CSF, Plasma
- Medical subject headings
- Alzheimer Disease, Pick Disease of the Brain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CSF drawing during spinal anaesthesiaDiagnostic test
4mL of CSF by lumbar puncture
Fasting blood sampleDiagnostic test
6x5 mL of fasting blood sample
Lumbar punctureDiagnostic test
10 mL of CSF by lumbar puncture
| Study group | Role | What they receive |
|---|---|---|
| Controls | Group 1: the 4ml of CSF collected in the surgery context will be kept for the study, and 6x5ml of blood will be added to the usual samples. Receives: Diagnostic Test: CSF drawing during spinal anaesthesia; Diagnostic Test: Fasting blood sample | |
| Asymptomatic cases with high risk to develop AD | Group 2: 10ml of CSF and 6x5ml of blood will be collected Receives: Diagnostic Test: Fasting blood sample; Diagnostic Test: Lumbar puncture | |
| Cases with isolated cognitive complaint | Group 3: 10ml of CSF and 6x5ml of blood will be collected Receives: Diagnostic Test: Fasting blood sample; Diagnostic Test: Lumbar puncture | |
| Prodromal AD | Group 4: 10ml of CSF and 6x5ml of blood will be collected Receives: Diagnostic Test: Fasting blood sample; Diagnostic Test: Lumbar puncture | |
| Mild to moderate probable AD-type dementia | Group 5: 10ml of CSF and 6x5ml of blood will be collected Receives: Diagnostic Test: Fasting blood sample; Diagnostic Test: Lumbar puncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of Tau in extracellular vesicles in CSF
Tau will be measured by ELISA in extracellular vesicles and the presence of Tau in extracellular vesicles will considered positive if the concentration of Tau is superior to the sensitivity threshold of the antibody used.
Measured: Baseline
Secondary outcomes (2)
The ratio of free Tau/vesicular Tau for all groups will be assessed with samples obtained during the visit.
Tau will be measured by ELISA (concentration of Tau in pg/mL) and using the Nanosight technology (% of vesicles containing Tau). Results will be expressed either in percentage or in concentration (ie concentration of free Tau/concentration of vesicular Tau; % of free Tau/% of vesicular Tau).
Measured: Baseline
The presence of clusters of the epigenetic markers H3K9me3 in nuclei of peripheral blood mononuclear cells for all groups will be assessed with samples obtained during the visit.
The H3K9m3 marker will be revealed by immunodetection and revealed by fluorescence. The presence of one cluster of H3K9m3 will be considered as positive. Results will be expressed in % of cells with clusters.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2017
- Study start20 Dec 2017
- Primary completion21 Dec 2022
- Study completion23 Dec 2022
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 University Hospital, LilleThe 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
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vincent DERAMECOURT, MD,PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03381482
- Sponsor's protocol ID
- 2016_59
- Other IDs
- 2017-A01715-48
- Acronym
- ECTAUSOME
- Status last verified
- Aug 2025
- First submitted
- 18 Dec 2017
- Last updated
- 20 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ectosomes, New Biomarkers of Tau Pathology?
- ClinicalTrials.gov ID
- NCT03381482
- Acronym / sponsor ID
- ECTAUSOME / 2016_59
- Conditions
- Alzheimer Disease
- Keywords
- Alzheimer disease, Extracellular vesicles, Biomarker, Tau, CSF, Plasma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 20 Dec 2017 (actual)
- Primary completion
- 21 Dec 2022 (actual)
- Study completion
- 23 Dec 2022 (actual)
- First posted
- 22 Dec 2017 (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.
In Alzheimer's disease (AD), neurofibrillary degeneration (NFD) is characterized by the intraneuronal aggregation of Tau proteins. The pathology progresses through a hierarchical pathway that may be associated with the intercellular transmission of pathology as demonstrated in our rat models. This transmission implies that Tau is actively secreted and may participate to the first steps of Tau pathology spreading. It is demonstrated in cell lines and animal models (rodents and non-human primates) that Tau is secreted not only in free forms but also in extracellular vesicles. If Tau is found in biological fluids before neuronal death it may represent an early marker of the NFD and will also define therapeutically targets. In this context, the aim is now to transfer this knowledge in humans and to decipher the nature of Tau secreted in plasma and cerebrospinal fluids collected from healthy controls to AD patients, and to decipher if the presence of tau inside vesicles is influenced by the pathology.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Controls | – | Diagnostic Test: CSF drawing during spinal anaesthesia, Diagnostic Test: Fasting blood sampleGroup 1: the 4ml of CSF collected in the surgery context will be kept for the study, and 6x5ml of blood will be added to the usual samples. |
| Asymptomatic cases with high risk to develop AD | – | Diagnostic Test: Fasting blood sample, Diagnostic Test: Lumbar punctureGroup 2: 10ml of CSF and 6x5ml of blood will be collected |
| Cases with isolated cognitive complaint | – | Diagnostic Test: Fasting blood sample, Diagnostic Test: Lumbar punctureGroup 3: 10ml of CSF and 6x5ml of blood will be collected |
| Prodromal AD | – | Diagnostic Test: Fasting blood sample, Diagnostic Test: Lumbar punctureGroup 4: 10ml of CSF and 6x5ml of blood will be collected |
| Mild to moderate probable AD-type dementia | – | Diagnostic Test: Fasting blood sample, Diagnostic Test: Lumbar punctureGroup 5: 10ml of CSF and 6x5ml of blood will be collected |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects intended to participate in group 1 have to undergo a lumbar puncture for other reasons than a cognitive complaint. They will be identified in the anaesthesiology department among patients who are waiting for scheduled orthopaedic surgery needing spinal anaesthesia. They will have the sample collection done with its specific procedures in the same time. if a subject is already followed at the MRRC and meets group 1 eligibility criteria, he/she could be asked to participate in the study and thus be enrolled and followed by a MRRC investigator. Patients intended to participate in groups 2 to 5 will be identified at the MRRC during their scheduled visit with the investigators specialized in neurology/geriatric medicine.
Key inclusion criteria (19 listed)
- Subjects able to undergo a lumbar puncture;
- Subjects who have a partner who will be required for driving back the subject after the lumbar punction for safety reasons (not required for control subjects);
- Subjects (or the study partner for group 5) capable of and willing to comply with the protocol and to give their written informed consents after having received and understood the subject information. According to the legal protection or the mental capacities of the subject, he/she will be accompanied by him/her legally acceptable representative during this procedure;
- Blood coagulation testing
- Subjects registered with the French Social Security, in agreement with the French law on biomedical experimentation.
Key exclusion criteria (13 listed)
- MMSE between 15 and 26 (inclusive)
- Subjects with dementia caused by a non-neurodegenerative disease, including patients with severe cerebrovascular risk factor load;
- Subjects with other neurodegenerative disease such as fronto-temporal dementia (FTD), Lewy body dementia and Parkinson's disease;
- Subjects with other serious neurological disorder such as brain tumour, stroke, epilepsy, hydrocephalus and any condition which contraindicates, in the investigator's judgment, entry to the study;
- Subjects with demyelinating diseases of the peripheral nervous system such as Guillain-Barre Syndrome;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CSF drawing during spinal anaesthesia4mL of CSF by lumbar puncture | Diagnostic test | Controls |
| Fasting blood sample6x5 mL of fasting blood sample | Diagnostic test | Asymptomatic cases with high risk to develop AD, Cases with isolated cognitive complaint, Controls, Mild to moderate probable AD-type dementia, Prodromal AD |
| Lumbar puncture10 mL of CSF by lumbar puncture | Diagnostic test | Asymptomatic cases with high risk to develop AD, Cases with isolated cognitive complaint, Mild to moderate probable AD-type dementia, Prodromal AD |
Primary outcome
Presence of Tau in extracellular vesicles in CSF
Time frame: Baseline
Tau will be measured by ELISA in extracellular vesicles and the presence of Tau in extracellular vesicles will considered positive if the concentration of Tau is superior to the sensitivity threshold of the antibody used.
2 secondary outcomes
The ratio of free Tau/vesicular Tau for all groups will be assessed with samples obtained during the visit.
Time frame: Baseline
The presence of clusters of the epigenetic markers H3K9me3 in nuclei of peripheral blood mononuclear cells for all groups will be assessed with samples obtained during the visit.
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2025.
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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. This study is not recruiting at the moment.
Vincent DERAMECOURT, MD,PhD principal investigator
University Hospital, Lille
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, run by University Hospital, Lille 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 19 inclusion and 13 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: finished, as of the sponsor's last update on 20 Aug 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of Tau in extracellular vesicles in CSF (time frame: Baseline). 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 20 Aug 2025.