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Search / Trial NCT06875739

An Innovative Method in SAliva Samples for the Early Differential Diagnosis of High-impact NeuroDegenerative Diseases Through Raman Spectroscopy

Launched by FONDAZIONE DON CARLO GNOCCHI ONLUS · Mar 11, 2025

Trial Information

Current as of April 23, 2025

Enrolling by invitation

Keywords

ClinConnect Summary

No description provided

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • FOR ALL SUBJECTS: between 60 and 85 years old
  • FOR CASE:
  • 1. 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.
  • 2. FTD: diagnosis of FTD-bv (behavioral variant) according to current clinical criteria.
  • 3. PD: diagnosis according to MDS criteria; stable drug treatment (last 4 weeks).
  • 4. 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.
  • 5. ALS: clinical diagnosis according to the criteria of Brooks (2000) and subsequent revisions.
  • FOR CONTROL SUBJECTS
  • 1. subjects admitted to IRCCS Don Gnocchi Florence in the departments of cardiology, pulmonology, orthopedics
  • 2. ABSENCE of neurological symptoms
  • 3. ABSENCE OF diagnosis of neurological or psychiatric diseases.
  • 4. absence of positive family history (relatives I and II degree) for NDDs.
  • 5. condition of clinical stability
  • 6. at least 15 days after the acute event causing hospitalization.
  • FOR PRODROMAL CASE
  • 1. Prodromal PD according to Berg's criteria.
  • 2. prodromal FTD-bv according to Barker's criteria
  • 3. prodromal AD according to the criteria of Dubois and Albert
  • Exclusion Criteria:
  • FOR CASE
  • 1. Vascular Parkinsonism and other forms of secondary Parkinsonism such as drug-induced, other known or suspected causes (metabolic, brain tumor, etc.).
  • 2. MoCA\<15 for subjects with PD
  • 3. cases with validated biomarkers (CSF and PET) in diagnostic conflict.
  • FOR ALL SUBJECTS
  • 1. significant comorbidities
  • 2. presence of severe systemic diseases or previously diagnosed psychiatric illnesses
  • 3. patients unable to express consent for participation in the study themselves
  • 4. presence of clinically unstable oral cavity disease (inflammatory/infectious)
  • 5. time since acute event (if it occurred) \<15 days
  • 6. presence of local or systemic infection/inflammation detected on routine examinations.

About Fondazione Don Carlo Gnocchi Onlus

Fondazione Don Carlo Gnocchi Onlus is a distinguished non-profit organization dedicated to advancing healthcare and rehabilitation services for individuals with disabilities and chronic illnesses. Established in honor of the legacy of Don Carlo Gnocchi, the foundation focuses on integrating scientific research with clinical practice, striving to enhance the quality of life for patients through innovative therapies and comprehensive care programs. With a commitment to excellence, the foundation actively engages in clinical trials and research initiatives aimed at improving treatment outcomes and fostering a deeper understanding of rehabilitation methodologies. Its collaborative approach brings together healthcare professionals, researchers, and community stakeholders to promote well-being and support patient-centric solutions.

Locations

Cagliari, , Italy

Florence, , Italy

Florence, , Italy

Milano, , Italy

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported