Saliva and Extracellular Vesicles for Neurodegenerative Diseases
NCT06869135, Recruiting, Fondazione Don Carlo Gnocchi ETS
Trial 9
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Saliva and Extracellular Vesicles for Neurodegenerative Diseases | ClinicalTrials.gov |
| NCT number | NCT06869135 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Enrollment | 242 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Fondazione Don Carlo Gnocchi ETS | ClinicalTrials.gov |
| Conditions | Neurodegenerative Diseases, Parkinson Disease, Alzheimer Disease, Parkinsonism, Mild Cognitive Impairment (MCI), Prodromal Parkinson's Disease | ClinicalTrials.gov |
| Interventions | Saliva collection, longitudinal | ClinicalTrials.gov |
| First posted | 2025-03-11 | ClinicalTrials.gov |
| Last updated | 2025-08-07 | ClinicalTrials.gov |
Registered outcomes 7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Salivary Raman fingerprint of AD, PD, AtPD, prodromal PD and MCI | From the enrollment to the follow up evaluation and second sample collection at 12 months | Differences in the Raman spectra of saliva of patients with AD, PD, AtPD, prodromal PD and MCI in the spectral range 400-1800 cm-1 | ClinicalTrials.gov |
| Secondary | Raman fingerprint of salivary EV of AD, PD, AtPD, prodromal PD and MCI | From the enrollment to the follow up evaluation and second sample collection at 12 months | Differences in the Raman spectra of saliva derived EVs of patients with AD, PD, AtPD, prodromal PD and MCI in the spectral ranges 600-1800 cm-1 and 2600-3200 cm-1 | ClinicalTrials.gov |
| Secondary | Salivary NDD biomarkers | From enrollment to follow up evaluation and second sample collection at 12 months | Quantification of NDDs related markers by SiMoA technology: * asyn for PD, AtP and pPD * Aβ1-42 for AD and MCI * NfL as general biomarkers of neurological damage in all groups. Changes in concentration are expected between groups and for the same patient between T0 and T12. | ClinicalTrials.gov |
| Secondary | Salivary Raman fingerprint of patients after 1 year | From enrollment to follow up and second sample collection at 12 months | Changes in the Raman spectra of saliva between T0 (enrollment) and T12 (1 year after enrollment) associated to disease progression. | ClinicalTrials.gov |
| Secondary | Salivary EV Raman fingerprint of patients after 1 year | From enrollment to follow up and second sample collection at 12 months | Changes in the Raman spectra of saliva derived EVs between T0 (enrollment) and T12 (1 year after enrollment) associated to disease progression. | ClinicalTrials.gov |
| Secondary | Correlation of Raman data with clinical assessment | From enrollment to follow up at 12 months | Correlation between spectral data of saliva and saliva derived EVs at T0 and T12 and clinical assessment (Cumulative Illness Rating Scale/CIRS; modified Barthel Index/mBI; Montreal Cognitive Assessment/MoCA; SAND Test; Fluency test; Trail Making Test A and B/TMT-A and B; Stroop Test ; Rey Test; Rey Complex Figure/RCF; Face Test; Neuropsychiatric Inventory/NPI; Frontal Assessment Battery/FAB) | ClinicalTrials.gov |
| Secondary | Correlation of Raman data with biomolecular data | From enrollment to follow up at 12 months | Correlation between spectral data of saliva and saliva derived EVs at T0 and T12 and biomolecular quantification of i) asyn for PD, AtP and pPD; ii) Aβ1-42 for AD and MCI; iii) NfL for all subjects | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 2
The papers the trial lists on ClinicalTrials.gov.
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 3
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Complex Figure Copy and Recall | Secondary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
| Trail Making Test A | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)