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Creation of a Clinical Database for the Study of Phenotypic Variability in Motor Neuron Diseases (ALS-PHENO)

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ClinicalTrials.gov Identifier: NCT06318585
Recruitment Status : Recruiting
First Posted : March 19, 2024
Last Update Posted : March 19, 2024
Sponsor:
Information provided by (Responsible Party):
Istituto Auxologico Italiano

Study Description
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Brief Summary:

Study Description: Characterization of Motor Neuron Disease Phenotypes

The goal of this observational study is to understand the clinical presentation of motor neuron disease (MND) in patients attending the Neurology Department of the Istituto Auxologico Italiano. The main questions it aims to answer are:

  • What are the specific clinical phenotypes associated with MND?
  • How can these phenotypes contribute to a better understanding of the disease's underlying mechanisms and improve prognostic accuracy?

Participants will undergo:

  • Clinical evaluation using validated scales
  • Neurophysiological and neuroradiological instrumental assessment
  • Neuropsychological evaluation
  • Collection of biological materials for genetic screening and biomarker assessment, if necessary.

Condition or disease
Amyotrophic Lateral Sclerosis Motor Neuron Disease

Study Design
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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Creazione di un Database Clinico Per lo Studio Della variabilità Fenotipica Nella Malattia Del Motoneurone
Actual Study Start Date : April 3, 2023
Estimated Primary Completion Date : December 31, 2026
Estimated Study Completion Date : December 31, 2026

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. no. of patients with classic ALS [ Time Frame: baseline (at diagnosis), at 1 year ]
    no. of patients with classic ALS

  2. no. of patients with bulbar ALS [ Time Frame: baseline (at diagnosis), at 1 year ]
    no. of patients with bulbar ALS

  3. no. of patients with LMN phenotypes (flail arm, flail leg, PMA) [ Time Frame: baseline (at diagnosis), at 1 year ]
    no. of patients with LMN phenotypes (flail arm, flail leg, PMA)

  4. no. of patients with UMN phenotypes (pyramidal ALS, PLS) [ Time Frame: baseline (at diagnosis), at 1 year ]
    no. of patients with UMN phenotypes (pyramidal ALS, PLS)


Biospecimen Retention:   Samples With DNA
DNA, plasma, serum, CSF

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Consecutive cohort of patients from a tertiary Italian ALS Centre
Criteria

Inclusion Criteria:

  • diagnosis of ALS or other motor neuron disease

Exclusion Criteria:

  • refusal to participate to the study
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06318585


Contacts
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Contact: Nicola Ticozzi, MD, PhD +390261911 ext 2937 n.ticozzi@auxologico.it

Locations
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Italy
Ospedale San Luca Recruiting
Milano, MI, Italy, 20149
Contact: Alberto Doretti, MD    +0261911 ext 2937    a.doretti@auxologico.it   
Sponsors and Collaborators
Istituto Auxologico Italiano
More Information
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Responsible Party: Istituto Auxologico Italiano
ClinicalTrials.gov Identifier: NCT06318585    
Other Study ID Numbers: 23C306
First Posted: March 19, 2024    Key Record Dates
Last Update Posted: March 19, 2024
Last Verified: March 2024

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
 Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases