Genetics and Environment iNtersection In the ALS-FTD Spectrum: an Italian Twins Cohort studY With a Multi-Omics Approach

ConditionsALSFTD
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAzienda Ospedaliero-Universitaria di Modena

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • multiomic profile to assess genetic and environmental risk factiors

Treatment groups

45 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Azienda Ospedaliero-Universitaria di Modena

Lead sponsor

A.O.U. Città della Salute e della Scienza - Molinette Hospital

Collaborator

Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo

Collaborator

University of Modena and Reggio Emilia

Collaborator

Azienda Ospedaliero-Universitaria Careggi

Collaborator