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Optical Coherence Tomography in Neurological Practice: Utility and Applicability Across Neurological Diseases (OCt.IN.N) (OCT)

17 luglio 2026 aggiornato da: Prof. Massimo Filippi, IRCCS San Raffaele

A National, Monocentric, Prospective Cohort Study to Evaluate the Utility and Applicability of Optical Coherence Tomography in Neurological Clinical Practice

OCt.IN.N is a national, monocentric, prospective, observational cohort study evaluating the utility and applicability of Optical Coherence Tomography (OCT) in the diagnostic workup and longitudinal monitoring of neurological diseases.

840 patients with Central Nervous System neurological diseases (Multiple Sclerosis, Alzheimer's disease, Parkinson's disease, migraine/headache) and 210 age-matched healthy controls will undergo OCT examination at baseline and at 6, 12, 18, and 24 months of follow-up at IRCCS San Raffaele Hospital, Milan, Italy.

OCT is a non-invasive, rapid, and reproducible technique that automatically measures the thickness of individual retinal layers. Retinal layer thicknesses and their longitudinal changes will be correlated with established clinical scales, neuroimaging, and biological markers used in routine neurological practice.

Panoramica dello studio

Stato

Stato

Indica lo stato di reclutamento attuale o lo stato di accesso ampliato.
Reclutamento

Condizioni

Condizioni

La malattia, il disturbo, la sindrome, la malattia o la lesione oggetto di studio. Su ClinicalTrials.gov, le condizioni possono includere anche altri problemi relativi alla salute, come la durata della vita, la qualità della vita e i rischi per la salute.

Intervento / Trattamento

Intervento / Trattamento

Un processo o un'azione che è al centro di uno studio clinico. Gli interventi includono farmaci, dispositivi medici, procedure, vaccini e altri prodotti sperimentali o già disponibili. Gli interventi possono anche includere approcci non invasivi, come l'educazione o la modifica della dieta e dell'esercizio fisico.

Descrizione dettagliata

The retina and optic nerve share the same embryological origins as the central nervous system (CNS). Several neurological diseases - including Multiple Sclerosis (MS), Parkinson's disease (PD), and Alzheimer's disease (AD) - involve the visual system at both pre-chiasmatic (neuro-retina, optic nerve) and post-chiasmatic levels (optic tracts, optic radiations, primary visual cortex).

In MS, optic neuritis is one of the most frequent manifestations and can lead to optic nerve damage with retinal nerve fiber degeneration. In neurodegenerative diseases such as AD and PD, degeneration of retinal ganglion cells has been demonstrated. In AD, longitudinal observational studies have shown accelerated RNFL thinning over time compared to age-matched healthy controls, suggesting that neuro-retinal thinning in neurodegeneration reflects underlying neurodegenerative processes independent of normal aging.

Spectral-domain Optical Coherence Tomography (OCT) is a non-invasive, highly reproducible technique providing automated, high-resolution information on the thickness of individual retinal layers, including the retinal nerve fiber layer (RNFL), the ganglion cell layer (GCL), and the inner plexiform layer (IPL). OCT could represent a reliable, reproducible, and economically accessible tool for the diagnostic workup and monitoring of neurological diseases.

The device used is the Heidelberg SPECTRALIS HRA+OCT (Class IIa CE-marked medical device), operated according to the manufacturer's instructions and indications for use. The device is used according to its approved clinical indication for visualization of the posterior segment of the eye and retinal anatomy measurement.

Study design: monocentric, prospective, observational cohort study. Patients are recruited from the neurology outpatient clinics and inpatient wards of IRCCS San Raffaele Hospital. OCT is performed at baseline (T0) and at follow-up visits at 6, 12, 18, and/or 24 months. Ophthalmological evaluation may be requested at the investigators' discretion to exclude concurrent ocular pathology.

Three age subgroups are analyzed for all disease groups and controls: 20-40 years, 40-60 years, and over 60 years.

Statistical analyses include: descriptive statistics and ANOVA models (or non-parametric tests) for between-group comparisons at baseline; linear mixed-effects models for longitudinal changes over time; generalized estimating equations (GEE) when data from both eyes are considered; Pearson or Spearman correlation analyses between OCT measures and clinical, neuroimaging, and biological markers (EDSS for MS; UPDRS for PD; neuropsychological battery for AD; brain MRI, PET, and CSF biomarkers for migraine/headache).

Tipo di studio

Tipo di studio

Descrive la natura di uno studio clinico. I tipi di studio includono studi interventistici (chiamati anche studi clinici), studi osservazionali (compresi i registri dei pazienti) e accesso allargato.
Osservativo

Iscrizione (Stimato)

Iscrizione

Il numero di partecipanti a uno studio clinico. L'iscrizione "anticipata" è il numero target di partecipanti di cui i ricercatori hanno bisogno per lo studio.
1050

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Contatto studio

Il nome e le informazioni di contatto della persona che può rispondere alle domande di iscrizione per uno studio clinico. Ogni sede in cui viene condotto lo studio può anche avere un contatto specifico, che potrebbe essere maggiormente in grado di rispondere a tali domande.

Backup dei contatti dello studio

  • Nome: Roberto Santangelo, MD

Luoghi di studio

  • Italia
    • Milano
      • Milan, Milano, Italia, 20132
        • Reclutamento
        • IRCCS Ospedale San Raffaele - Neurology and Neurophysiology Unit
        • Contatto:
        • Investigatore principale:
          • Massimo Filippi, Prof, MD
        • Sub-investigatore:
          • Federica Agosta, MD
        • Sub-investigatore:
          • Roberto Santangelo, MD
        • Contatto:
          • Roberto Santangelo, MD

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Criteri di ammissibilità

I requisiti chiave che devono soddisfare le persone che vogliono partecipare a uno studio clinico o le caratteristiche che devono avere. I criteri di ammissibilità sono costituiti sia da criteri di inclusione (necessari a una persona per partecipare allo studio) sia da criteri di esclusione (che impediscono a una persona di partecipare). I tipi di criteri di ammissibilità includono se uno studio accetta volontari sani, ha requisiti di età o gruppo di età o è limitato dal sesso.

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

Sì

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

Adult patients with a diagnosis of a Central Nervous System neurological disease (Multiple Sclerosis; Alzheimer's disease; Parkinson's disease; migraine/headache) recruited from the neurology outpatient clinics and inpatient wards of IRCCS San Raffaele Hospital, Milan, Italy. Healthy controls recruited primarily from medical students, colleagues, and relatives of patients.

Descrizione

Inclusion Criteria for neurological patients:

  1. Diagnosis of a Central Nervous System neurological disease (inflammatory diseases such as Multiple Sclerosis; neurodegenerative diseases such as Alzheimer's disease and Parkinson's disease; migraine/headache) according to currently accepted diagnostic criteria for each condition.
  2. Age greater than 18 years.
  3. Signed informed consent to study participation.
  4. Willingness and ability to undergo all study visits and procedures.

Inclusion Criteria for healthy controls:

  1. Absence of neurological disease.
  2. Age greater than 18 years.
  3. Signed informed consent to study participation.
  4. Willingness and ability to undergo all study visits and procedures.

Exclusion Criteria for neurological patients:

  1. Refusal to participate or withdrawal of informed consent.
  2. Known or confirmed ocular pathology identified during examination (ophthalmological evaluation may be requested at the investigators' discretion).
  3. Inability to understand instructions given by investigators.
  4. Presence of any condition that, in the investigators' opinion, renders the subject unsuitable for the study.
  5. For specific imaging modes using clearly visible light sources (MultiColor, FA, BAF): diagnosis of epilepsy or history of previous epileptic seizures.

Exclusion Criteria for healthy controls:

  1. Refusal to participate or withdrawal of informed consent.
  2. Known or confirmed ocular pathology identified during examination.
  3. Inability to understand instructions given by investigators.
  4. Presence of any condition that, in the investigators' opinion, renders the subject unsuitable for the study.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte

Gruppo / Coorte

Un gruppo o sottogruppo di partecipanti a uno studio osservazionale che viene valutato per gli esiti biomedici o sanitari.
Intervento / Trattamento

Intervento / Trattamento

Un processo o un'azione che è al centro di uno studio clinico. Gli interventi includono farmaci, dispositivi medici, procedure, vaccini e altri prodotti sperimentali o già disponibili. Gli interventi possono anche includere approcci non invasivi, come l'educazione o la modifica della dieta e dell'esercizio fisico.
Multiple Sclerosis patients
210 patients with a diagnosis of Multiple Sclerosis according to current diagnostic criteria, stratified into three age subgroups (20-40, 40-60, and over 60 years, 70 per subgroup). Undergo OCT at baseline and follow-up visits at 6, 12, 18, and/or 24 months, alongside standard clinical assessments including EDSS.
Dispositivo: Optical Coherence Tomography (OCT) - Heidelberg SPECTRALIS HRA+OCT

Spectral-domain Optical Coherence Tomography (OCT) performed using the Heidelberg SPECTRALIS HRA+OCT device (Class IIa CE-marked medical device). The procedure is non-invasive: the patient sits in front of the device and is asked to fix a target (light or cross) through a lens. No drugs or contrast agents are administered. OCT automatically acquires images of the macular region (where GCL and IPL are most represented) and the optic nerve head region (where RNFL is most represented), providing automated measurements of the thickness of individual retinal layers.

OCT is performed at baseline and at follow-up visits at 6, 12, 18, and/or 24 months. Ophthalmological evaluation may be performed at the investigators' discretion if OCT images, clinical symptoms, or medical history suggest concurrent ocular pathology. Patients with a known diagnosis of epilepsy or history of epileptic seizures will not undergo specific imaging modes using clearly visible light sources (MultiColor, FA, BAF).
Alzheimer's disease patients
210 patients with a diagnosis of Alzheimer's disease according to current diagnostic criteria, stratified into three age subgroups (70 per subgroup). Undergo OCT at baseline and follow-up visits alongside standard neuropsychological assessments, brain MRI, PET, and CSF biomarkers as part of routine clinical care.
Dispositivo: Optical Coherence Tomography (OCT) - Heidelberg SPECTRALIS HRA+OCT

Spectral-domain Optical Coherence Tomography (OCT) performed using the Heidelberg SPECTRALIS HRA+OCT device (Class IIa CE-marked medical device). The procedure is non-invasive: the patient sits in front of the device and is asked to fix a target (light or cross) through a lens. No drugs or contrast agents are administered. OCT automatically acquires images of the macular region (where GCL and IPL are most represented) and the optic nerve head region (where RNFL is most represented), providing automated measurements of the thickness of individual retinal layers.

OCT is performed at baseline and at follow-up visits at 6, 12, 18, and/or 24 months. Ophthalmological evaluation may be performed at the investigators' discretion if OCT images, clinical symptoms, or medical history suggest concurrent ocular pathology. Patients with a known diagnosis of epilepsy or history of epileptic seizures will not undergo specific imaging modes using clearly visible light sources (MultiColor, FA, BAF).
Parkinson's disease patients
210 patients with a diagnosis of Parkinson's disease according to current diagnostic criteria, stratified into three age subgroups (70 per subgroup). Undergo OCT at baseline and follow-up visits alongside standard clinical assessments including UPDRS.
Dispositivo: Optical Coherence Tomography (OCT) - Heidelberg SPECTRALIS HRA+OCT

Spectral-domain Optical Coherence Tomography (OCT) performed using the Heidelberg SPECTRALIS HRA+OCT device (Class IIa CE-marked medical device). The procedure is non-invasive: the patient sits in front of the device and is asked to fix a target (light or cross) through a lens. No drugs or contrast agents are administered. OCT automatically acquires images of the macular region (where GCL and IPL are most represented) and the optic nerve head region (where RNFL is most represented), providing automated measurements of the thickness of individual retinal layers.

OCT is performed at baseline and at follow-up visits at 6, 12, 18, and/or 24 months. Ophthalmological evaluation may be performed at the investigators' discretion if OCT images, clinical symptoms, or medical history suggest concurrent ocular pathology. Patients with a known diagnosis of epilepsy or history of epileptic seizures will not undergo specific imaging modes using clearly visible light sources (MultiColor, FA, BAF).
Migraine and headache patients
210 patients with a diagnosis of migraine or headache according to current diagnostic criteria, stratified into three age subgroups (70 per subgroup). Undergo OCT at baseline and follow-up visits alongside standard clinical assessments.
Dispositivo: Optical Coherence Tomography (OCT) - Heidelberg SPECTRALIS HRA+OCT

Spectral-domain Optical Coherence Tomography (OCT) performed using the Heidelberg SPECTRALIS HRA+OCT device (Class IIa CE-marked medical device). The procedure is non-invasive: the patient sits in front of the device and is asked to fix a target (light or cross) through a lens. No drugs or contrast agents are administered. OCT automatically acquires images of the macular region (where GCL and IPL are most represented) and the optic nerve head region (where RNFL is most represented), providing automated measurements of the thickness of individual retinal layers.

OCT is performed at baseline and at follow-up visits at 6, 12, 18, and/or 24 months. Ophthalmological evaluation may be performed at the investigators' discretion if OCT images, clinical symptoms, or medical history suggest concurrent ocular pathology. Patients with a known diagnosis of epilepsy or history of epileptic seizures will not undergo specific imaging modes using clearly visible light sources (MultiColor, FA, BAF).
Healthy Controls
210 healthy subjects without neurological disease, age-matched to patients, stratified into three age subgroups (20-40, 40-60, and over 60 years, 70 per subgroup). Recruited primarily from medical students, colleagues, and relatives of patients. Undergo OCT at baseline and follow-up visits.
Dispositivo: Optical Coherence Tomography (OCT) - Heidelberg SPECTRALIS HRA+OCT

Spectral-domain Optical Coherence Tomography (OCT) performed using the Heidelberg SPECTRALIS HRA+OCT device (Class IIa CE-marked medical device). The procedure is non-invasive: the patient sits in front of the device and is asked to fix a target (light or cross) through a lens. No drugs or contrast agents are administered. OCT automatically acquires images of the macular region (where GCL and IPL are most represented) and the optic nerve head region (where RNFL is most represented), providing automated measurements of the thickness of individual retinal layers.

OCT is performed at baseline and at follow-up visits at 6, 12, 18, and/or 24 months. Ophthalmological evaluation may be performed at the investigators' discretion if OCT images, clinical symptoms, or medical history suggest concurrent ocular pathology. Patients with a known diagnosis of epilepsy or history of epileptic seizures will not undergo specific imaging modes using clearly visible light sources (MultiColor, FA, BAF).

Cosa sta misurando lo studio?

Misure di risultato primarie

Misure di risultato primarie

Nel protocollo di uno studio clinico, la misura dell'esito pianificato più importante per valutare l'effetto di un intervento/trattamento. La maggior parte degli studi clinici ha una misura di esito primaria, ma alcuni ne hanno più di una.
Misura del risultato
Misura Descrizione
Lasso di tempo
Annual rate of peripapillary RNFL thinning in patients with Multiple Sclerosis vs healthy controls
Lasso di tempo: Baseline, 6, 12, 18, and 24 months
Annualized thinning rate (micrometers per year) of the peripapillary retinal nerve fiber layer (RNFL) measured by OCT in patients with Multiple Sclerosis compared to age-matched healthy controls.
Baseline, 6, 12, 18, and 24 months
Annual rate of peripapillary RNFL thinning in patients with Alzheimer's Disease vs healthy controls
Lasso di tempo: Baseline, 6, 12, 18, and 24 months
Annualized thinning rate (micrometers per year) of the peripapillary retinal nerve fiber layer (RNFL) measured by OCT in patients with Alzheimer's Disease compared to age-matched healthy controls.
Baseline, 6, 12, 18, and 24 months
Annual rate of peripapillary RNFL thinning in patients with Parkinson's Disease vs healthy controls
Lasso di tempo: Baseline, 6, 12, 18, and 24 months
Annualized thinning rate (micrometers per year) of the peripapillary retinal nerve fiber layer (RNFL) measured by OCT in patients with Parkinson's Disease compared to age-matched healthy controls.
Baseline, 6, 12, 18, and 24 months
Annual rate of macular GCL thinning in patients with Multiple Sclerosis disease vs healthy controls
Lasso di tempo: Baseline, 6, 12, 18, and 24 months
Annualized thinning rate (micrometers per year) of the macular ganglion cell layer (GCL) measured by OCT in patients with Multiple Sclerosis compared to age-matched healthy controls
Baseline, 6, 12, 18, and 24 months
Annual rate of macular GCL thinning in patients with Alzheimer's Disease vs healthy controls
Lasso di tempo: Baseline, 6, 12, 18, and 24 months
Annualized thinning rate (micrometers per year) of the macular ganglion cell layer (GCL) measured by OCT in patients with Alzheimer's Disease compared to age-matched healthy controls
Baseline, 6, 12, 18, and 24 months
Annual rate of macular GCL thinning in patients with Parkinson's Disease vs healthy controls
Lasso di tempo: Baseline, 6, 12, 18, and 24 months
Annualized thinning rate (micrometers per year) of the macular ganglion cell layer (GCL) measured by OCT in patients with Parkinson's Disease compared to age-matched healthy controls
Baseline, 6, 12, 18, and 24 months
Annual rate of macular IPL thinning in patients with Multiple Sclerosis vs healthy controls
Lasso di tempo: Baseline, 6, 12, 18, and 24 months
Annualized thinning rate (micrometers per year) of the macular inner plexiform layer (IPL) measured by OCT in patients with Multiple Sclerosis compared to age-matched healthy controls
Baseline, 6, 12, 18, and 24 months
Annual rate of macular IPL thinning in patients with Alzheimer's Disease vs healthy controls
Lasso di tempo: Baseline, 6, 12, 18, and 24 months
Annualized thinning rate (micrometers per year) of the macular inner plexiform layer (IPL) measured by OCT in patients with Alzheimer's Disease compared to age-matched healthy controls
Baseline, 6, 12, 18, and 24 months
Annual rate of macular IPL thinning in patients with Parkinson's Disease vs healthy controls
Lasso di tempo: Baseline, 6, 12, 18, and 24 months
Annualized thinning rate (micrometers per year) of the macular inner plexiform layer (IPL) measured by OCT in patients with Parkinson's Disease compared to age-matched healthy controls
Baseline, 6, 12, 18, and 24 months

Misure di risultato secondarie

Misure di risultato secondarie

Nel protocollo di uno studio clinico, una misura dell'esito pianificato che non è importante quanto la misura dell'esito primario per valutare l'effetto di un intervento ma è comunque di interesse. La maggior parte degli studi clinici ha più di una misura di esito secondaria.
Misura del risultato
Misura Descrizione
Lasso di tempo
Correlation between RNFL thinning rate and EDSS worsening in Multiple Sclerosis
Lasso di tempo: Baseline, 6, 12, 18, and 24 months
Pearson or Spearman correlation between the annualized RNFL thinning rate measured by OCT and worsening on the Expanded Disability Status Scale (EDSS) in patients with Multiple Sclerosis.
Baseline, 6, 12, 18, and 24 months
Correlation between GCL thinning rate and EDSS worsening in Multiple Sclerosis
Lasso di tempo: Baseline, 6, 12, 18, and 24 months
Pearson or Spearman correlation between the annualized GCL thinning rate measured by OCT and worsening on the Expanded Disability Status Scale (EDSS) in patients with Multiple Sclerosis.
Baseline, 6, 12, 18, and 24 months
Correlation between IPL thinning rate and EDSS worsening in Multiple Sclerosis
Lasso di tempo: Baseline, 6, 12, 18, and 24 months
Pearson or Spearman correlation between the annualized IPL thinning rate measured by OCT and worsening on the Expanded Disability Status Scale (EDSS) in patients with Multiple Sclerosis.
Baseline, 6, 12, 18, and 24 months
Correlation between RNFL thinning rate and UPDRS worsening in Parkinson's disease
Lasso di tempo: Baseline, 6, 12, 18, and 24 months
Pearson or Spearman correlation between the annualized RNFL thinning rate measured by OCT and worsening on the Unified Parkinson's Disease Rating Scale (UPDRS) in patients with Parkinson's disease.
Baseline, 6, 12, 18, and 24 months
Correlation between GCL thinning rate and UPDRS worsening in Parkinson's disease
Lasso di tempo: Baseline, 6, 12, 18, and 24 months
Pearson or Spearman correlation between the annualized GCL thinning rate measured by OCT and worsening on the Unified Parkinson's Disease Rating Scale (UPDRS) in patients with Parkinson's disease.
Baseline, 6, 12, 18, and 24 months
Correlation between RNFL thinning rate and neuropsychological performance in Alzheimer's disease
Lasso di tempo: Baseline, 6, 12, 18, and 24 months
Pearson or Spearman correlation between the annualized RNFL thinning rate measured by OCT and scores on comprehensive neuropsychological assessment in patients with Alzheimer's disease.
Baseline, 6, 12, 18, and 24 months
Correlation between GCL thinning rate and neuropsychological performance in Alzheimer's disease
Lasso di tempo: Baseline, 6, 12, 18, and 24 months
Pearson or Spearman correlation between the annualized GCL thinning rate measured by OCT and scores on comprehensive neuropsychological assessment in patients with Alzheimer's disease.
Baseline, 6, 12, 18, and 24 months
Correlation between IPL thinning rate and neuropsychological performance in Alzheimer's disease
Lasso di tempo: Baseline, 6, 12, 18, and 24 months
Pearson or Spearman correlation between the annualized IPL thinning rate measured by OCT and scores on comprehensive neuropsychological assessment in patients with Alzheimer's disease.
Baseline, 6, 12, 18, and 24 months
Correlation between RNFL thickness and brain MRI lesion load
Lasso di tempo: Baseline, 6, 12, 18, and 24 months
Pearson or Spearman correlation between OCT-derived RNFL tickness and brain MRI parameters (lesion load) used in routine clinical practice for each neurological disease subgroup.
Baseline, 6, 12, 18, and 24 months
Correlation between RNFL thickness and brain MRI cortical atrophy
Lasso di tempo: Baseline, 6, 12, 18, and 24 months
Pearson or Spearman correlation between OCT-derived RNFL tickness and brain MRI parameters (cortical atrophy) used in routine clinical practice for each neurological disease subgroup.
Baseline, 6, 12, 18, and 24 months
Correlation between GCL thickness and brain MRI lesion load
Lasso di tempo: Baseline, 6, 12, 18, and 24 months
Pearson or Spearman correlation between OCT-derived GCL tickness and brain MRI parameters (lesion load) used in routine clinical practice for each neurological disease subgroup.
Baseline, 6, 12, 18, and 24 months
Correlation between GCL thickness and brain MRI cortical atrophy
Lasso di tempo: Baseline, 6, 12, 18, and 24 months
Pearson or Spearman correlation between OCT-derived GCL tickness and brain MRI parameters (cortical atrophy) used in routine clinical practice for each neurological disease subgroup.
Baseline, 6, 12, 18, and 24 months
Correlation between IPL thickness and brain MRI lesion load
Lasso di tempo: Baseline, 6, 12, 18, and 24 months
Pearson or Spearman correlation between OCT-derived IPL tickness and brain MRI parameters (lesion load) used in routine clinical practice for each neurological disease subgroup.
Baseline, 6, 12, 18, and 24 months
Correlation between IPL thickness and brain MRI cortical atrophy
Lasso di tempo: Baseline, 6, 12, 18, and 24 months
Pearson or Spearman correlation between OCT-derived IPL tickness and brain MRI parameters (cortical atrophy) used in routine clinical practice for each neurological disease subgroup.
Baseline, 6, 12, 18, and 24 months
Correlation between RNFL thickness and PET findings
Lasso di tempo: Baseline, 6, 12, 18, and 24 months
Pearson or Spearman correlation between OCT-derived RNFL thickness and brain PET parameters used in routine clinical practice for applicable neurological disease subgroups.
Baseline, 6, 12, 18, and 24 months
Correlation between GCL thickness and PET findings
Lasso di tempo: Baseline, 6, 12, 18, and 24 months
Pearson or Spearman correlation between OCT-derived GCL thickness and brain PET parameters used in routine clinical practice for applicable neurological disease subgroups.
Baseline, 6, 12, 18, and 24 months
Correlation between IPL thickness and PET findings
Lasso di tempo: Baseline, 6, 12, 18, and 24 months
Pearson or Spearman correlation between OCT-derived IPL thickness and brain PET parameters used in routine clinical practice for applicable neurological disease subgroups.
Baseline, 6, 12, 18, and 24 months
24. Correlation between RNFL thickness and CSF biomarker (Abeta40)
Lasso di tempo: Baseline, 6, 12, 18, and 24 months
Pearson or Spearman correlation between OCT-derived RNFL thickness and CSF biomarkers (Abeta40) in applicable neurological disease subgroups.
Baseline, 6, 12, 18, and 24 months
Correlation between GCL thickness and CSF biomarker (Abeta40)
Lasso di tempo: Baseline, 6, 12, 18, and 24 months
Pearson or Spearman correlation between OCT-derived GCL thickness and CSF biomarkers (Abeta40) in applicable neurological disease subgroups.
Baseline, 6, 12, 18, and 24 months
orrelation between IPL thickness and CSF biomarker (Abeta40)
Lasso di tempo: Baseline, 6, 12, 18, and 24 months
Pearson or Spearman correlation between OCT-derived IPL thickness and CSF biomarkers (Abeta40) in applicable neurological disease subgroups.
Baseline, 6, 12, 18, and 24 months
Correlation between RNFL thickness and CSF biomarker (Abeta42)
Lasso di tempo: Baseline, 6, 12, 18, and 24 months
Pearson or Spearman correlation between OCT-derived RNFL thickness and CSF biomarkers (Abeta42) in applicable neurological disease subgroups.
Baseline, 6, 12, 18, and 24 months
Correlation between GCL thickness and CSF biomarker (Abeta42)
Lasso di tempo: Baseline, 6, 12, 18, and 24 months
Pearson or Spearman correlation between OCT-derived GCL thickness and CSF biomarkers (Abeta42) in applicable neurological disease subgroups.
Baseline, 6, 12, 18, and 24 months
Correlation between IPL thickness and CSF biomarker (Abeta42)
Lasso di tempo: Baseline, 6, 12, 18, and 24 months
Pearson or Spearman correlation between OCT-derived IPL thickness and CSF biomarkers (Abeta42) in applicable neurological disease subgroups.
Baseline, 6, 12, 18, and 24 months
Correlation between RNFL thickness and CSF biomarkers (pTAU)
Lasso di tempo: Baseline, 6, 12, 18, and 24 months
Pearson or Spearman correlation between OCT-derived RNFL thickness and CSF biomarkers (pTAU) in applicable neurological disease subgroups.
Baseline, 6, 12, 18, and 24 months
Correlation between GCL thickness and CSF biomarkers (pTAU)
Lasso di tempo: Baseline, 6, 12, 18, and 24 months
Pearson or Spearman correlation between OCT-derived GCL thickness and CSF biomarkers (pTAU) in applicable neurological disease subgroups.
Baseline, 6, 12, 18, and 24 months
Correlation between IPL thickness and CSF biomarkers (pTAU)
Lasso di tempo: Baseline, 6, 12, 18, and 24 months
Pearson or Spearman correlation between OCT-derived IPL thickness and CSF biomarkers (pTAU) in applicable neurological disease subgroups.
Baseline, 6, 12, 18, and 24 months
Correlation between RNFL thickness and CSF biomarkers (NfL)
Lasso di tempo: Baseline, 6, 12, 18, and 24 months
Pearson or Spearman correlation between OCT-derived RNFL thickness and CSF biomarkers (NfL) in applicable neurological disease subgroups.
Baseline, 6, 12, 18, and 24 months
Correlation between GCL thickness and CSF biomarkers (NfL)
Lasso di tempo: Baseline, 6, 12, 18, and 24 months
Pearson or Spearman correlation between OCT-derived GCL thickness and CSF biomarkers (NfL) in applicable neurological disease subgroups.
Baseline, 6, 12, 18, and 24 months
Correlation between IPL thickness and CSF biomarkers (NfL)
Lasso di tempo: Baseline, 6, 12, 18, and 24 months
Pearson or Spearman correlation between OCT-derived IPL thickness and CSF biomarkers (NfL) in applicable neurological disease subgroups.
Baseline, 6, 12, 18, and 24 months

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Sponsor

L'organizzazione o la persona che avvia lo studio e che ha autorità e controllo sullo studio.
IRCCS San Raffaele

Investigatori

Investigatori

Un ricercatore coinvolto in uno studio clinico. I termini correlati includono il ricercatore principale del sito, il ricercatore secondario del sito, il presidente dello studio, il direttore dello studio e il ricercatore principale dello studio.
  • Investigatore principale: Massimo Filippi, Prof, MD, IRCCS San Raffaele

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

Inizio studio

La data effettiva in cui il primo partecipante è stato arruolato in uno studio clinico. La data di inizio dello studio "prevista" è la data che i ricercatori pensano sarà la data di inizio dello studio.
9 ottobre 2023

Completamento primario (Stimato)

Completamento primario

La data in cui l'ultimo partecipante a uno studio clinico è stato esaminato o ha ricevuto un intervento per raccogliere i dati finali per la misura dell'esito primario. Il fatto che lo studio clinico sia terminato secondo il protocollo o sia stato interrotto non influisce su questa data. Per gli studi clinici con più di una misura di esito primario con diverse date di completamento, questo termine si riferisce alla data in cui la raccolta dei dati è completata per tutte le misure di esito primario. La data di completamento principale "prevista" è la data che i ricercatori ritengono sarà la data di completamento principale per lo studio.
1 aprile 2030

Completamento dello studio (Stimato)

Completamento dello studio

La data in cui l'ultimo partecipante a uno studio clinico è stato esaminato o ha ricevuto un intervento/trattamento per raccogliere i dati finali per le misure di esito primarie, le misure di esito secondarie e gli eventi avversi (ovvero l'ultima visita dell'ultimo partecipante). La data di completamento dello studio "prevista" è la data che i ricercatori ritengono sarà la data di completamento dello studio.
1 aprile 2031

Date di iscrizione allo studio

Primo inviato

Primo inviato

La data in cui lo sponsor o il ricercatore dello studio ha inviato per la prima volta un record di studio a ClinicalTrials.gov. In genere c'è un ritardo di alcuni giorni tra la prima data di invio e la disponibilità del record su ClinicalTrials.gov (la prima data di invio).
17 luglio 2026

Primo inviato che soddisfa i criteri di controllo qualità

Primo inviato che soddisfa i criteri di controllo qualità

La data in cui lo sponsor dello studio o il ricercatore invia per la prima volta un record di studio che è coerente con i criteri di revisione del controllo di qualità (QC) della National Library of Medicine (NLM). Lo sponsor o lo sperimentatore potrebbe dover rivedere e inviare un record di studio una o più volte prima che i criteri di revisione QC di NLM siano soddisfatti. È responsabilità dello sponsor o dello sperimentatore garantire che il record dello studio sia coerente con i criteri di revisione QC NLM.
17 luglio 2026

Primo Inserito (Effettivo)

Primo Inserito

La data in cui il record dello studio è stato disponibile per la prima volta su ClinicalTrials.gov dopo la conclusione della revisione del controllo di qualità (QC) della National Library of Medicine (NLM). In genere c'è un ritardo di alcuni giorni tra la data in cui lo sponsor dello studio o lo sperimentatore ha presentato il record dello studio e la prima data pubblicata.
22 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

Ultimo aggiornamento pubblicato

La data più recente in cui le modifiche al record di uno studio sono state rese disponibili su ClinicalTrials.gov. Potrebbe esserci un ritardo tra il momento in cui le modifiche sono state inviate a ClinicalTrials.gov dallo sponsor o dallo sperimentatore dello studio (data di invio dell'ultimo aggiornamento) e la data di pubblicazione dell'ultimo aggiornamento.
22 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

Ultimo aggiornamento inviato che soddisfa i criteri QC

La data più recente in cui lo sponsor dello studio o il ricercatore ha presentato modifiche a un record di studio che sono coerenti con i criteri di revisione del controllo di qualità (QC) della National Library of Medicine (NLM). È responsabilità dello sponsor o dello sperimentatore garantire che il record dello studio sia coerente con i criteri di revisione QC NLM.
17 luglio 2026

Ultimo verificato

Ultimo verificato

La data più recente in cui lo sponsor dello studio o il ricercatore ha confermato che le informazioni su uno studio clinico su ClinicalTrials.gov sono accurate e aggiornate. Se uno studio con stato di reclutamento di reclutamento; non ancora reclutamento; o attivo, non reclutamento non è stato confermato negli ultimi 2 anni, lo stato di reclutamento dello studio viene mostrato come sconosciuto.
1 luglio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

Altri numeri di identificazione dello studio

Identificatori o numeri ID diversi dal numero NCT assegnati a uno studio clinico dallo sponsor, dai finanziatori o da altri dello studio. Questi numeri possono includere identificatori univoci di altri registri di sperimentazione e numeri di sovvenzioni del National Institutes of Health.
  • OCtINN

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

INDECISO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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