GENFI Lille is a French cohort that belongs to the international initiative GENFI2, a five year longitudinal biomarker cohort study of genetic FTD and its associated disorders (including MND/ALS) investigating members of families with a known mutation in GRN or MAPT or an expansion in C9orf72 (including those affected with the disorder as well as at-risk members of families).
- Study Type: Interventional
- Study Design
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Diagnostic
- Masking: None (Open Label)
- Study Primary Completion Date: April 23, 2021
The purposes of this study is : – to improve characterization of symptomatic FTD patients or presymptomatic subjects at risk of genetic FTD – to develop markers indicative of the optimal time to start disease-modifying therapy, based on the proximity to clinical onset. – to develop markers of disease progression that can be used as outcome measures. – to derive sample size estimates for clinical trials. Participants will include those affected with the disorder as well as at-risk members of families (both mutation carriers and non-carrier first-degree relatives who will serve as a control group). All participants will be assessed longitudinally with a set of clinical, neuropsychiatric, cognitive, imaging and biosample protocols.
- Diagnostic Test: Investigation procedures
- All participants will be assessed longitudinally with a set of clinical evaluation, neuropsychiatric and cognitive assessments, imaging (MRI and PET scans) and biosample (CSF, blood samples)
Arms, Groups and Cohorts
- Other: asymptomatic at-risk individual
- First-degree relative of a family member affected with the frontotemporal dementia.
- Other: symptomatic individual
- Patient who has been clinically diagnosed by a neurologist as having frontotemporal dementia or a disorder in the FTD spectrum
Clinical Trial Outcome Measures
- Difference of the proportion of symptomatic FTD patients or presymptomatic subjects at risk of genetic FTD
- Time Frame: each year during 2 years
- Characterization of patients and describe multi characteristics of disease
Participating in This Clinical Trial
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
- Lead Sponsor
- University Hospital, Lille
- Provider of Information About this Clinical Study
- Overall Official(s)
- Thibaud LEBOUVIER, MD, Ph, Principal Investigator, CHU de Lille
- Overall Contact(s)
- Thibaud LEBOUVIER, MD, Ph, 03 20 44 60 21, email@example.com
Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.