Genetics and Environment iNtersection In the ALS-FTD Spectrum: an Italian Twins Cohort studY With a Multi-Omics Approach
Recruiting · NCT06595212 · Observational (researchers observe without assigning treatment) · Lead sponsor: Azienda Ospedaliero-Universitaria di Modena
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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. The main questions it aims to answer is: * How far does the genetic background explain the onset of ALS/FTD in discordant twins? * Which environmental factors and events occurring in post-fetal life influence the onset or progression of this neurodegenerative condition? Participants with ALS and/or FTD with a monozygotic or dizygotic twin willing to contribute to this research will be followed up for two years by specialized Motor Neuron Disorders centers in Italy, donating biological specimen for -omic sciences analysis, and checking out if prodromal signs/symptoms of these two conditions will develop during time.
Who can take part
Inclusion criteria
- 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 criteria
- 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
Where it is running
3 locations listed.
- Azienda Ospedaliero-Universitaria di Modena - Modena, Italy, Italy
- Azienda Ospedaliero-Universitaria Policlinico P. Giaccone di Palermo - Palermo, Italy, Italy
- Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino - Torino, Italy, Italy