PNRR: M6/C2_CALL 2023 Full Proposal– Call section: Proof of concept
Project Code: PNRR-POC-2023-12377141
Duration: 30 months (31/08/2024 – 28/02/2027)
Early diagnosis of neurodegenerative diseases and accurate patient profiling are key and emergent goals needed to impact disease progression and patient’s quality of life.
The evolution of neurodegenerative diseases involves cognition, behavior and motor domains of clinical assessment that result in lifelong functional and social impairments with high economic and social costs. The biochemical pathophysiological drivers occur far earlier than symptoms appearance making the identification of subjects with preclinical disease the basis for early diagnosis, needed for an effective therapy.
The clinical definition of neurodegenerative diseases is basically insufficient, therefore, a disease-specific biomarker is needed, that considers the individual complex clinical picture and that can be periodically measured in an accessible and low cost, biofluid as saliva.
The SANDY project is aimed at the validation of a biophotonic based diagnostic method and at the creation of a point-of care using a portable instrument on an accessible biofluid that could be used for routine clinical monitoring of disease progression.
The feasibility of the project is directly related to the saliva sample and proposed technology (Raman spectroscopy) that has been already tested in the clinical setting.
Raman spectroscopy analysis of saliva will be combined with gold standard methods (biomarkers detection in blood and cerebrospinal fluid) to validate the Raman spectroscopy platform for neurodegenerative diseases early diagnosis and differential patients profiling, creating an integrated platform that could be used as decision support tool for a prompt tailored pharmacological and rehabilitation intervention.
SANDY is a project funded by Italian Ministry of Health under the PNRR call M6/C2_CALL 2023 – Proof of Concept.
SANDY is coordinated by Fondazione Don Gnocchi (PI: Prof. Benedetta Nacmias, Co-PI: Dr. Marzia Bedoni).
Project Partners:
Multiple operative units of Fondazione Don Gnocchi are involved in the project activities:
Year 1
In the first year of the project, a shared REDCap database has been successfully developed to coordinate data collection among all research groups involved in the project.
Standardized procedures for the collection, storage, and transport of biological samples have been established to ensure consistency and reliability. Experimental teams also agreed on coordinated shipping schedule to ensure sample quality.
The project has made strong progress in participant recruitment. After approval from Local Ethics Committeee, the team has started the enrolment of healthy controls, people with Parkinson’s disease but also individuals with atypical parkinsonism, Alzheimer’s disease, frontotemporal dementia, and amyotrophic lateral sclerosis.
Blood samples were successfully collected from about 90% of participants, while saliva samples were obtained from everyone.
The LABION team has finalized the Raman analysis protocols for both benchtop and portable instruments and have begun analyzing the saliva of enrolled participants.
Year 2
In the second year of the project, the clinical and experimental teams worked in synergy to successfully recruit healthy volunteers, people with Parkinson’s disease but also individuals with atypical parkinsonism, Alzheimer’s disease, frontotemporal dementia, and amyotrophic lateral sclerosis.
Biological samples were successfully collected as well as saliva samples and by the end of the second year.
The LABION team is actively analyzing the saliva of enrolled participants for both benchtop and portable Raman spectroscopes. In May 2026, the LABION team has filed a patent application for the Raman-based method for the analysis of saliva in the diagnosis of neurodegenerative diseases, accomplishing the main deliverable of the project.
The quantification of specific plasma, serum and saliva biomarkers is ongoing using ultrasensitive platforms like SR-X – Simoa technology (Quanterix) and Bio-Plex 200 thanks to the expertise of all Partner laboratories.
On 16th January 2027, Fondazione Don Gnocchi will host an event open to all those interested in the SANDY project. Clinicians specializing in neurological disorders, together with experts in emerging treatment strategies for Parkinson’s disease, Alzheimer’s disease and Amyotrophic Lateral Sclerosis, will discuss with patients, caregivers, patient associations and researchers the current and future directions in the diagnosis and care of neurodegenerative disorders. The day will bring a lively mix of talks, music and live demonstrations of physical activities tailored to patients with neurodegenerative diseases, with plenty of moments for networking.
