Actively Recruiting
The Skin as a Window to the Central Nervous System in Frontotemporal Lobar Degeneration
Led by Nantes University Hospital · Updated on 2024-12-20
80
Participants Needed
1
Research Sites
132 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Frontotemporal lobar degeneration (FTLD) is a group of disorders causing progressive changes in behavior and language, linked to abnormal protein deposits called Tau and TDP-43 in the brain. This research explores whether these proteins can also be found in the skin, which might help diagnose FTLD since there are currently no reliable biomarkers for this condition. The study includes patients with various forms of FTLD and healthy volunteers for comparison, conducted over two years at Nantes University Hospital. Participants will undergo a single small skin biopsy under local anesthesia to collect a sample for analysis of nerve fibers and protein deposits. Both patients and healthy volunteers will provide blood samples as well. The study includes people aged 50 to 75 with different clinical presentations of FTLD and a matched group of healthy individuals. During the study, researchers will assess the amounts of Tau and TDP-43 proteins in the skin at inclusion. Participants will be evaluated with cognitive tests such as the MMSE or MOCA. The study monitors safety and collects data to understand the relationship between skin protein changes and FTLD, potentially offering a new diagnostic tool for this neurodegenerative syndrome.
CONDITIONS
Official Title
The Skin as a Window to the Central Nervous System in Frontotempolar Lombar Degeneration
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Addressed or followed at memory clinic or ALS expert center at Nantes University Hospital
- Aged 50 to 75 years
- Diagnosed with one of the following disorders: behavioral variant frontotemporal dementia, non-Alzheimer primary progressive aphasia (semantic or non-fluent), corticobasal degeneration, progressive supranuclear palsy, or amyotrophic lateral sclerosis
- Mini-Mental State Examination (MMSE) score of 18 or higher
- Membership of social security scheme
- No history of neurological disease, diabetes, or peripheral nervous system damage for healthy volunteers
- Healthy volunteers aged 50 to 75 years, matched to patients within 5 years of age
- Montreal Cognitive Assessment (MOCA) score of 26 or higher for healthy volunteers
- Membership of social security scheme for healthy volunteers
You will not qualify if you...
- Conditions affecting the peripheral nervous system such as diabetes, renal failure, thyroid disorder, vitamin B12 deficiency, acute or chronic inflammatory diseases, HIV, or syphilis
- Known allergy to local anesthetic
- Known blood clotting disorders
- Pregnant or breastfeeding women
- Persons under court protection or guardianship
- Inability to provide informed consent
- Patients with neurological diseases other than FTLD
- Healthy volunteers with evidence of neurological disorders including Parkinson's disease, Alzheimer's disease, Lewy body dementia, Huntington disease, systemic lupus erythematosus, multiple sclerosis, learning disabilities, mental retardation, severe brain injury, or permanent cognitive impairments after brain trauma
AI-Screening
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Trial Site Locations
Total: 1 location
1
Nantes University Hospital
Nantes, France, 44093
Actively Recruiting
Research Team
C
Claire BOUTOLEAU-BRETONNIERE, MD
P
pascal DERKINDEREN, Pr
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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