Actively Recruiting

Age: 18Years +
All Genders
ID06856850

Disease Biosignatures in ALS/FTD Spectrum: New Impactful Biological Perspectives Beyond Clinical Approaches

Led by Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta · Updated on 2026-03-30

230

Participants Needed

4

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating the ALS/FTD disease spectrum, which includes amyotrophic lateral sclerosis (ALS) and frontotemporal dementia (FTD). These two conditions share clinical, genetic, and pathological features and may even occur together in some patients. Diagnosis mainly depends on clinical symptoms, making it challenging. This study aims to discover new biological markers, called biosignatures, to improve diagnosis, patient classification, and monitoring of disease progression using advanced methods and multidisciplinary expertise.

CONDITIONS

Brief Title

Disease Biosignatures in ALS/FTD Spectrum: New Impactful Biological Perspectives Beyond Clinical Approaches

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Clinical diagnosis of ALS according to Brooks et al., 2000; de Carvalho M., 2008 criteria
  • Clinical diagnosis of FTD according to Gorno-Tempini et al., 2011; Rascovsky et al., 2011 criteria
  • Adults aged 18 years or older
Not Eligible

You will not qualify if you...

  • na

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Up to 12 months

Participants undergo extensive clinical and neuropsychological assessments, including the Burghart Sniffin' Sticks test, before sample collection.

Multiple visits for assessments and sample collection

Sample Collection and Analysis

Duration - Up to 24 months

Participants provide various biological samples including cerebrospinal fluid, blood, tears, skin, and olfactory mucosa for biomarker discovery and validation analyses.

Multiple visits depending on sample type and cohort assignment

Long-term Monitoring

Duration - Up to 24 months

Participants' data and samples are analyzed over time to identify disease biosignatures and understand disease progression in the ALS/FTD spectrum.

Follow-up assessments and sample collections as scheduled

Trial Site Locations

Total: 4 locations

1

Fondazione IRCCS Istituto Neurologico Carlo Besta

Milan, Italy, 20133

Actively Recruiting

2

Università degli Studi di Napoli "Federico II"

Naples, Italy, 80131

Not Yet Recruiting

3

Azienda Ospedaliero Universitaria di Sassari

Sassari, Italy, 07100

Not Yet Recruiting

4

Consorzio Interuniversitario Risonanze Magnetiche Metallo Proteine (CIRMMP)

Sesto Fiorentino, Italy, 50019

Not Yet Recruiting

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Research Team

F

Fabio Moda, phd

A

Arianna Ciullini, phd

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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