Status:
ENROLLING_BY_INVITATION
An Innovative Method in SAliva Samples for the Early Differential Diagnosis of High-impact NeuroDegenerative Diseases Through Raman Spectroscopy
Lead Sponsor:
Fondazione Don Carlo Gnocchi Onlus
Collaborating Sponsors:
University of Cagliari, Cagliari, Italy
Conditions:
Neurodegenerative Disorders
Parkinson Disease
Eligibility:
All Genders
60-85 years
Brief Summary
The aim of the study is to validate a salivary test that allows for rapid and accurate objective diagnosis in the context of neurodegenerative diseases, a complex of diseases that includes Alzheimer's...
Eligibility Criteria
Inclusion
- FOR ALL SUBJECTS: between 60 and 85 years old
- FOR CASE:
- ADD: diagnosis of dementia due to AD according to clinical criteria and supported by amyloid biomarkers (biomarkers in CSF or brain PET scan with amyloid-specific tracer) according to the definition biological or neurochemical definition of disease.
- FTD: diagnosis of FTD-bv (behavioral variant) according to current clinical criteria.
- PD: diagnosis according to MDS criteria; stable drug treatment (last 4 weeks).
- APs: clinical diagnosis of Progressive Supranuclear Palsy according to the criteria of Hoglinger 2017, Corticobasal Degeneration according to the criteria of Armostrong 2013, Multisystem Atrophy according to the criteria of Wenning 2022.
- ALS: clinical diagnosis according to the criteria of Brooks (2000) and subsequent revisions.
- FOR CONTROL SUBJECTS
- subjects admitted to IRCCS Don Gnocchi Florence in the departments of cardiology, pulmonology, orthopedics
- ABSENCE of neurological symptoms
- ABSENCE OF diagnosis of neurological or psychiatric diseases.
- absence of positive family history (relatives I and II degree) for NDDs.
- condition of clinical stability
- at least 15 days after the acute event causing hospitalization.
- FOR PRODROMAL CASE
- Prodromal PD according to Berg's criteria.
- prodromal FTD-bv according to Barker's criteria
- prodromal AD according to the criteria of Dubois and Albert
Exclusion
- FOR CASE
- Vascular Parkinsonism and other forms of secondary Parkinsonism such as drug-induced, other known or suspected causes (metabolic, brain tumor, etc.).
- MoCA\<15 for subjects with PD
- cases with validated biomarkers (CSF and PET) in diagnostic conflict.
- FOR ALL SUBJECTS
- significant comorbidities
- presence of severe systemic diseases or previously diagnosed psychiatric illnesses
- patients unable to express consent for participation in the study themselves
- presence of clinically unstable oral cavity disease (inflammatory/infectious)
- time since acute event (if it occurred) \<15 days
- presence of local or systemic infection/inflammation detected on routine examinations.
Key Trial Info
Start Date :
February 14 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 1 2026
Estimated Enrollment :
310 Patients enrolled
Trial Details
Trial ID
NCT06875739
Start Date
February 14 2025
End Date
October 1 2026
Last Update
March 13 2025
Active Locations (4)
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1
Azienda Ospedaliera Universitaria di Cagliari
Cagliari, Italy
2
IRCCS Fondazione Don Carlo Gnocchi
Florence, Italy
3
Laboratorio Congiunto di Ricerca DON GNOCCHI - UNIFI neurogenetica in riabilitazione - NGR
Florence, Italy
4
IRCCS Fondazione Don Carlo Gnocchi, Milano
Milan, Italy