Genetics and Environment iNtersection In the ALS-FTD Spectrum: an Italian Twins Cohort studY With a Multi-Omics Approach
Genetics and Environment iNtersection In the Amyotrophic Lateral Sclerosis - FrontoTemporal Dementia Spectrum: an Italian Twins Cohort studY With a Multi-Omics Approach
Azienda Ospedaliero-Universitaria di Modena
45 participants
Jan 29, 2024
OBSERVATIONAL
Conditions
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. 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.
Eligibility
Inclusion Criteria5
- 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 Criteria3
- 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
Interventions
Genomic, epigenetic, proteomic, microbiome, immunology, biomarker, metabolite, pesticide, metal, and metalloid investigations will be conducted. The twins will be followed longitudinally from a clinical perspective, with biological sample collections to assess discordance and identify early disease signatures in unaffected individuals.
Locations(3)
View Full Details on ClinicalTrials.gov
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NCT06595212