Ectosomes, New Biomarkers of Tau Pathology?

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

71 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-12-20

Study Completion Date

2022-12-23

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

18F-Florbetaben PET Amyloid Imaging in Case of Intermediate CSF Biology for the Diagnosis of Alzheimer's Disease : a Pilot Study

NCT02556502

Amyloid PET Imaging

COMPLETED NA

New Imaging Biomarkers Predictive of MA Progression

NCT05939362

Alzheimer Disease Magnetic Resonance Spectroscopy Ultra High Field 7T +2 more

RECRUITING NA

Tanycytes in Alzheimer's Disease and Frontotemporal Dementia

NCT05288842

Alzheimer Disease Frontotemporal Dementia

RECRUITING

New CSF Biomarkers for Alzheimer's Disease

NCT03621839

Alzheimer Disease Dementia Neurodegenerative Diseases

RECRUITING

P75NTR, Diagnostic Biomarker for Alzheimer's Disease: Quantification Study in Cerebrospinal Fluid

NCT02946710

Alzheimer Disease

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Alzheimer Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

6x5 mL of fasting blood sample

Intervention Type DIAGNOSTIC_TEST

Lumbar puncture

10 mL of CSF by lumbar puncture

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

* 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
* exclusion of any differential diagnoses
* MMSE between 15 and 26 (inclusive)

Exclusion Criteria

* 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;

* 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).

Minimum Eligible Age

40 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No