Status:
RECRUITING
Genetics and Environment iNtersection In the ALS-FTD Spectrum: an Italian Twins Cohort studY With a Multi-Omics Approach
Lead Sponsor:
Azienda Ospedaliero-Universitaria di Modena
Collaborating Sponsors:
A.O.U. Città della Salute e della Scienza - Molinette Hospital
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo
Conditions:
ALS
FTD
Eligibility:
All Genders
18+ years
Brief Summary
The goal of this study is to learn from discordant twins affected by Amyotrophic Lateral Sclerosis and/or Frontotemporal Dementia the contribution of genetic background versus environmental exposure. ...
Detailed Description
The main objective of the study is to develop a prospective national twins cohort and virtual biobank collecting demographic, clinical and instrumental data and biological samples of twins with ALS/FT...
Eligibility Criteria
Inclusion
- Age \>18 yrs
- Presence of MZ or DZ twins in the family both willing to participate in the study and able to provide informed consent
- At least one twin is affected by ALS as defined by Gold Coast Criteria (Shefner et al., 2020) and/or by FTD as defined by Strong and colleagues (Strong et al., 2017)
- Subjects able and willing to comply with study procedures as per protocol
- Subjects able to understand, and capable of providing informed consent at screening visit before any protocol-specific procedures
Exclusion
- Unwillingness to perform assessments as stated in the protocol at least during baseline visit for both twins
- Unwillingness to donate biological samples collected at periphery (lumbar puncture excluded) for both twins
- Women who are pregnant or breastfeeding
Key Trial Info
Start Date :
January 29 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 30 2026
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT06595212
Start Date
January 29 2024
End Date
January 30 2026
Last Update
February 4 2025
Active Locations (3)
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1
Azienda Ospedaliero-Universitaria di Modena
Modena, Italy, Italy, 41125
2
Azienda Ospedaliero-Universitaria Policlinico P. Giaccone di Palermo
Palermo, Italy, Italy, 90127
3
Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino
Torino, Italy, Italy, 10126