---
title: Differentiate neurodegenerative diseases using saliva
nct_id: NCT06869135
status: RECRUITING
sponsor: Fondazione Don Carlo Gnocchi Onlus
study_type: OBSERVATIONAL
canonical_url: "https://parkinsonspathways.com/trial/NCT06869135"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT06869135"
last_fetched: "2026-05-10T14:08:15.545Z"
source: "Parkinson's Pathways (curated)"
---
# Differentiate neurodegenerative diseases using saliva

**Goal (in five words):** Differentiate neurodegenerative diseases using saliva

**Official Title:** Novel Method for Diagnosis of Neurodegenerative Diseases Based on Saliva Biochemical Profiling

**Trial ID:** [NCT06869135](https://clinicaltrials.gov/study/NCT06869135)

## Key Facts

- **Status:** RECRUITING
- **Study Type:** OBSERVATIONAL
- **Sponsor:** Fondazione Don Carlo Gnocchi Onlus
- **Target Enrollment:** 242 participants
- **Start Date:** 2025-01-24
- **Completion Date:** 2027-03
- **Conditions:** Neurodegenerative Diseases, Parkinson Disease, Alzheimer Disease, Parkinsonism, Mild Cognitive Impairment (MCI), Prodromal Parkinson's Disease
- **Interventions:** Saliva collection, longitudinal
- **Intervention Types:** OTHER

## Summary For Families

The goal is to find saliva-based biochemical markers that can help diagnose and distinguish Parkinson's, Alzheimer's, atypical parkinsonism, mild cognitive impairment, and even prodromal Parkinson's, so diagnosis could become easier and less invasive. The approach collects saliva samples over time and uses biochemical profiling to look for proteins, metabolites, or other molecules that reflect brain changes, offering a painless, repeatable way to complement or reduce the need for spinal fluid or imaging tests. They are enrolling adults 45 and older with diagnoses by standard criteria for PD, AD, atypical parkinsonism, prodromal PD, or MCI, who can consent and do not have active oral, infectious, oncological, or other systemic inflammatory diseases; PD participants should be on stable medication and not have vascular or drug-induced parkinsonism.

## Eligibility

- **Minimum age:** 45 Years
- **Sex:** ALL

### Full Criteria

```
Inclusion Criteria:

* AD: standard criteria for dementia due to AD with AD neurochemical demonstration.
* PD: MDS Criteria; modified Hoehn\&Yahr stages; stable pharmacological treatment (last 4 weeks).
* AtP: current consensus diagnostic criteria for progressive supranuclear palsy; corticobasal degeneration and multiple system atrophy.
* prodromic PD: according to diagnostic criteria by Berg;
* MCI: according to diagnostic criteria by Dubois and Albert.

Exclusion Criteria:

* For all the experimental groups considered, subjects with concomitant chronic and / or inflammatory diseases of the oral cavity, other systemic diseases, oncological or infectious diseases will be excluded.
* Patients not able to provide written informed consent autonomously will be excluded.
* For PD patients: Vascular, familiar and drug- induced parkinsonism, other known or suspected causes (metabolic, brain tumor etc) or any suggestive features of AtP; dementia with MoCA Test Correct Score\<15
```

## Locations (5)

- IRCCS Don Gnocchi, Fondazione Don Gnocchi, Florence, FI, Italy _(43.7792, 11.2463)_
  - Francesca Cecchi, MD — (CONTACT) — +390557393922 — fcecchi@dongnocchi.it
  - Francesca Cecchi, MD — (PRINCIPAL_INVESTIGATOR)
  - Cristina Polito — (SUB_INVESTIGATOR)
  - Alessio Faralli — (SUB_INVESTIGATOR)
- Azienda Ospedaliero Universitaria Careggi Firenze, Florence, Italy _(43.7792, 11.2463)_
  - Silvia Ramat, MD, PhD — (CONTACT) — silvia.ramat@unifi.it
  - Silvia Ramat — (PRINCIPAL_INVESTIGATOR)
- IRCCS S. Maria Nascente, Fondazione Don Carlo Gnocchi ONLUS, Milan, Italy _(45.4643, 9.1895)_
  - Alice Gualerzi, PhD — (CONTACT) — agualerzi@dongnocchi.it
  - Alice Gualerzi, PhD — (PRINCIPAL_INVESTIGATOR)
  - Pietro Arcuri, MD — (PRINCIPAL_INVESTIGATOR)
  - Marzia Bedoni, PhD — (SUB_INVESTIGATOR)
  - Silvia Picciolini, PhD — (SUB_INVESTIGATOR)
  - Francesca Lea Saibene, PhD — (SUB_INVESTIGATOR)
  - Luana Forleo — (SUB_INVESTIGATOR)
  - Aurora Mangolini — (SUB_INVESTIGATOR)
  - Anna Salvatore — (SUB_INVESTIGATOR)
  - Angelo Bellinvia — (SUB_INVESTIGATOR)
  - Sarah Feroldi — (SUB_INVESTIGATOR)
- IRCCS Istituto Neurologico "Carlo Besta", Milan, Italy _(42.7824, 12.5984)_
  - Gemma Lombardi — (CONTACT) — gemma.lombardi@istituto-besta.it
  - Giuseppe Di Fede — (PRINCIPAL_INVESTIGATOR)
  - Gemma Lombardi — (SUB_INVESTIGATOR)
- Centro S. Maria ai Servi, Fondazione Don Carlo Gnocchi Onlus, Parma, Italy _(44.7993, 10.3262)_
  - Valerio Brambilla, MD — (CONTACT) — vbrambilla@dongnocchi.it
  - Valerio Brambilla, MD — (PRINCIPAL_INVESTIGATOR)
  - Lorenzo Brambilla, MD — (SUB_INVESTIGATOR)
  - Beatrice Rizzi, MD — (SUB_INVESTIGATOR)

## Central Contacts

- Pietro Arcuri, MD — (CONTACT) — +390240308833 — parcuri@dongnocchi.it
- Alice Gualerzi, PhD — (CONTACT) — +390240308533 — agualerzi@dongnocchi.it

---

*Canonical: https://parkinsonspathways.com/trial/NCT06869135*  
*HTML version: https://parkinsonspathways.com/trial/NCT06869135*  
*Source data: https://clinicaltrials.gov/study/NCT06869135*