The Skin as a Window to the Central Nervous System in Frontotempolar Lombar Degeneration
NCT ID: NCT06490822
Last Updated: 2024-12-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
80 participants
INTERVENTIONAL
2024-12-17
2027-07-31
Brief Summary
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In pathological conditions such as FTLD, both proteins are aggregated and hyperphosphorylated.
It is now well established that the pathological process in some proteinopathies such as synucleinopathies (of which Parkinson's disease is the main representative) is not limited to the brain but also widespread throughout the peripheral autonomic networks, including the autonomic innervation of the skin. In this context, many independent studies have shown that the pathological process in PD could be detected using routine punch skin biopsies opening the way for the development of original histopathological markers of the disease.
Our hypothesis is that such a scenario could also occur in FTLDs and that the detection of the pathological tau or TDP-43 protein in the skin could help in diagnosing FTLD. This is especially relevant as, despite the recent progress in genetics, neurobiology and neuroimaging, there are no available biomarkers for FTLD.
Detailed Description
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Healthy volunteers will be included as comparative group. A skin biopsy and venous blood samples will be collected for all participants.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Single arm study
A single 3 mm-diameter punch skin biopsy will be obtained from FTLD patients and healthy volunteers at the C8 paravertebral under local anesthesia to analyze cutaneous innervation
Skin biopsy
A single 3 mm-diameter punch skin biopsy will be obtained from FTLD patients and healthy volunteers at the C8 paravertebral under local anesthesia to analyze cutaneous innervation
Interventions
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Skin biopsy
A single 3 mm-diameter punch skin biopsy will be obtained from FTLD patients and healthy volunteers at the C8 paravertebral under local anesthesia to analyze cutaneous innervation
Eligibility Criteria
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Inclusion Criteria
* Aged 50-75 years
* Fulfilling current diagnosis criteria for one of the disorder: vcfFTD, non-Alzheimer PPA (semantic or non fluent), DCB or PSP,ALS
* MMSE ≥ 18
* Membership of social security scheme
* No history of neurological disease, diabetes, or alteration/damage of peripheral nervous system
* Aged 50-75 years Paired to at least one patient on age (less or more 5 years)
* MOCA ≥ 26
* Membership of social security scheme
* Concomitting conditions affecting the peripheral nervous system such as but not limited to diabetes, renal failure, thyroid disorder, vitamin B12 deficiency, acute and chronic inflammatory diseases HIV, syphilis
* Know allergy to local anesthetic
* Known coagulopathy
* Pregnant women or breastfeeding women
* Person under court protection sous sauvegarde de justice
* Person under guardianship
* Inability to sign an informed consent
• Evidence of neurological disorder at the inclusion including but not limted to FTLD, Parkinson disease, Alzheimer disease, lewy body dementia, Huntington disease, systemic lupus erythematosus multiple sclerosis; learning disabilities, mental retardation, severe hypoxic brain injuries, brain trauma with permanent cognitive impairments.
50 Years
75 Years
ALL
Yes
Sponsors
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Nantes University Hospital
OTHER
Responsible Party
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Locations
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Nantes University Hospital
Nantes, , France
Countries
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Central Contacts
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Claire BOUTOLEAU-BRETONNIERE, MD
Role: CONTACT
Phone: 02 40 16 54 22
Email: claire.boutoleaubretonniè[email protected]
Facility Contacts
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Claire BOUTOLEAU BRETONNIERE, MD
Role: primary
Other Identifiers
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RC23_0575
Identifier Type: -
Identifier Source: org_study_id