An Innovative Method in SAliva Samples for the Early Differential Diagnosis of High-impact NeuroDegenerative Diseases Through Raman Spectroscopy
NCT06875739, Unknown, Fondazione Don Carlo Gnocchi ETS
Trial 8
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | An Innovative Method in SAliva Samples for the Early Differential Diagnosis of High-impact NeuroDegenerative Diseases Through Raman Spectroscopy | ClinicalTrials.gov |
| NCT number | NCT06875739 | ClinicalTrials.gov |
| Status | Unknown | ClinicalTrials.gov |
| Enrollment | 310 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Fondazione Don Carlo Gnocchi ETS | ClinicalTrials.gov |
| Conditions | Neurodegenerative Disorders, Parkinson Disease, Alzheimer Disease, Parkinsonian Disorders, Fronto-temporal Dementia, Amyotrophic Lateral Sclerosis | ClinicalTrials.gov |
| First posted | 2025-03-13 | ClinicalTrials.gov |
| Last updated | 2025-03-13 | ClinicalTrials.gov |
Registered outcomes 21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Cumulative Illness Rating Scale (CIRS) | at enrollment | it's a scale that records the comorbidity | ClinicalTrials.gov |
| Primary | Neurological Clinical informations | at enrollment | Presence/absence of symptoms/signs such as presence of speech disorder, hearing loss, low vision, dysphagia, oculomotricity disorder, disorientation, decreased insight, fatuity, perseveration/affacceleration, dx/sn recognition inability, gait disorder, instability/falls, neglect, ideomotor apraxia, signs of frontal release, rigidity/spasticity, bradykinesia, tremor or other involuntary movements, signs of first or second motor neuron, need for use of aids/presence of medical aids. | ClinicalTrials.gov |
| Primary | Genetic test | at enrollment | genetic testing will lead in NDDs and CTRL to the determination of the ApoE polymorphism (categorical variable). In NDDs, diagnostic investigation will aim to confirm/exclude a mutation in one of the disease-causing genes (APP, PS1, PS2, MAPT, PGRN, C9ORF72, SOD 1, TARDBP, VCP) in accordance with the pathological phenotype | ClinicalTrials.gov |
| Primary | Plasma test | at enrollment | NfL and GFAP assay result on plasma (continuous numeric variables) | ClinicalTrials.gov |
| Primary | Salivary test | at enrollment | results of NfL and GFAP assay on saliva (continuous numeric variables) | ClinicalTrials.gov |
| Primary | nerological objective examination checklist | at enrollment | presence/absence of symptoms/signs such as presence of speech disorder, hearing impairment, low vision, dysphagia, oculomotor disorder, disorientation, decreased insight, fatuity, perseveration/affacility, dx/sn recognition inability, gait disorder, instability/falls, neglect, ideomotor apraxia, signs of frontal release, rigidity/spasticity, bradykinesia, tremor or other involuntary movements, signs of first or second motor neuron,need for use of aids/presence of medical aids (categorical variables) | ClinicalTrials.gov |
| Primary | UPDRS part III and IV | at enrollment | evaluation of motor symptoms only for subjects with parkinson's disease or parkinsonisms | ClinicalTrials.gov |
| Primary | Hoehn and Yahr Scale | at enrollment | evaluation of clinical status only for subjects with parkinson's disease | ClinicalTrials.gov |
| Primary | NON-MOTOR SYMPTOMS SCALE | at enrollment | evaluation of non motor symptoms only for subjects with parkinson's disease | ClinicalTrials.gov |
| Primary | Functional Rating Scale-Revised (ALSFRS-R) | at enrollment | evaluation of disability only for subjects with ALS | ClinicalTrials.gov |
| Primary | MONTREAL COGNITIVE ASSESSMENT (MOCA) | at enrollment | Cognitive screening test for all except control subjects | ClinicalTrials.gov |
| Primary | denomination test of SAND | at enrollment | denomination of visual stimuli for all subjects except control cases | ClinicalTrials.gov |
| Primary | semantic, phonemic and alternate fluency Test | at enrollment | semantic, phonemic and alternate fluency Test for all subjects except control cases | ClinicalTrials.gov |
| Primary | TRAIL MAKING TEST part A and B | at enrollment | evaluation of attentional skills for all subjects except control cases | ClinicalTrials.gov |
| Primary | STROOP TEST | at enrollment | evaluation of inhibitory control for all subjects except control cases | ClinicalTrials.gov |
| Primary | REY'S 15-WORD TEST | at enrollment | evaluation of long term memory for all subjects except control cases | ClinicalTrials.gov |
| Primary | REY OSTERRIETH COMPLEX FIGURE | at enrollment | evaluation of visuospatial skills for all subjects except control cases | ClinicalTrials.gov |
| Primary | FACE TEST | at enrollment | evaluation of ability to recognize mental states of others for all subjects except control cases | ClinicalTrials.gov |
| Primary | NEUROPSYCHIATRICH INVENTORY (NPI) | at enrollment | interview assessing behavioral of others for all subjects except control cases | ClinicalTrials.gov |
| Primary | FRONTAL ASSESSMENT BATTERY (FAB) | at enrollment | evaluation of executive functions; for all subjects except control cases | 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 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | 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 | Primary outcome | ConductCognition |
| Stroop Color-Word Test | Primary outcome | ConductCognition |
| Trail Making Test A | Primary outcome | ConductCognition |
Source 4
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.3.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 4a570df2e7274cee2d4fa2959402fab41880e2cd412e4b590390035fbea69391 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
Release trials-2026-11-12-0.3.0
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.