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

Plain-language summary

This study tests an innovative method that uses Raman spectroscopy on saliva samples for the early differential diagnosis of high-impact neurodegenerative diseases such as Alzheimer's disease, frontotemporal dementia, Parkinson's disease and ALS. People aged 60-85 who have one of these diagnoses, who are in an early (prodromal) stage, or who are healthy controls may take part. Conducted by Fondazione Don Carlo Gnocchi Onlus, this study without an assigned phase is enrolling participants by invitation.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

N/A

Status

Enrolling by invitation

Sponsor

Fondazione Don Carlo Gnocchi ETS

Start date

2/14/2025

Estimated completion

10/1/2026

Countries

Italy

Related genes

Locations

• Cagliari, Italy
• Florence, Italy
• Florence, Italy
• Milan, Italy

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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.