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

Study acronym: GENIALITY
StatusUnknown
PhaseNot specified
Started
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Record status
This record was last updated February 4, 2025 (before its estimated January 29, 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Changed Registry marked status Unknown (sponsor has not verified the record since Sep 2024); last known: Recruiting
  2. Primary endpoint revised
    • Site contacts updated at 3 of 3 sites
    v3
  3. Primary endpoint revised
    • Interventions: multiomic profile to assess genetic and environmental risk factiors (Other)
    • Site details revised at 3 of 3 sites
    • Study arms: 3 to 2
    v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06595212
Lead Sponsor Azienda Ospedaliero-Universitaria di Modena
Collaborators: A.O.U. Città della Salute e della Scienza - Molinette Hospital, Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo, University of Modena and Reggio Emilia, Azienda Ospedaliero-Universitaria Careggi
Conditions
(from sponsor)		 ALS, FTD
Enrollment 45 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov