NCT06490822Recruiting
The Skin as a Window to the Central Nervous System in Frontotempolar Lombar Degeneration
Source: ClinicalTrials.gov · Last updated 20 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Frontotemporal lobar degeneration (FTLD) is a clinically heterogeneous syndrome, characterized by progressive decline in behaviour and/or language. From a pathological standpoint, like the great majority of neurodegenerative disorders, FTLD are proteinopathies, which are characterized by the presence of specific protein deposits in the Central Nervous System (CNS). Accordingly, the two main deposits observed in FTLD are either made of Tau or transactive response DNA binding protein 43 (TDP-43). 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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- First submitted
- 25 Jun 2024
- Start date
- 17 Dec 2024
- Primary completion date
- Dec 2026
- Lead sponsor
- Nantes University Hospital
- Diseases
- Frontotemporal dementia
- NCT number
- NCT06490822
What you commit to
- Study type: Interventional
- Planned participants: 80
- From 17 Dec 2024 to the primary completion date, Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Who the study is looking for
- Adressed or followed at memory clinic or ALS expert center at Nantes university hospital.
- 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
- Non inclusion Criteria (Patients and healthy volunteers):
- 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
- Non inclusion criteria (Patients) • Patient with neurological disease other than FTLD
- Non inclusion criteria (Healthy volunteers) :
- 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.
Age in the registry: 50 years to 75 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Nantes University Hospital Coordinator of this site? Confirm its status | Nantes | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.