- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07567664
Tracking and Predicting How Brain Damage Spreads in Neurodegenerative Diseases
Tracking and Predicting Neurodegeneration Spreading Across the Brain Connectome
Neurodegenerative diseases, including frontotemporal lobar degeneration (FTLD) spectrum syndromes, are characterized by the accumulation of insoluble protein aggregates in the central nervous system. A common feature of these diseases is that pathological changes accumulate over time following a stereotyped spatial pattern, which contributes to the onset and progression of clinical symptoms. Until recently, the causes of such progression were still unknown. Recent pathological and neuroimaging studies have, however, suggested that insoluble and pathological protein aggregates are able to alter the conformation of neighboring proteins and spread through cell-to-cell transmission. According to this theory, called the 'brain connectome,' the brain network is established as a set of nodes, which correspond to different anatomical regions.
These brain networks are highly connected to each other and their internal organization is fundamental for an efficient integration of information coming from different regions and to guarantee adequate levels of motor/cognitive performance. Thanks to magnetic resonance studies and research in the field of brain networks, it is possible to understand the pathophysiology of neurodegenerative diseases and reveal the connectivity profiles associated with different clinical outcomes.
The main objective of this project is to explore the mechanisms of neurodegeneration associated with the different FTLD spectrum syndromes, and in particular the hypothesis that the neurodegenerative process is driven by the structural architecture of the brain 'connectome'. The ultimate goal is to apply mathematical models to structural and functional connectivity data to predict the evolution of the neurodegenerative process in sporadic and genetic forms of Frontotemporal Lobar Degeneration Disease.
This study aims to investigate the spatiotemporal progression of neurodegeneration in frontotemporal lobar degeneration (FTLD) using advanced neuroimaging and connectomics. 360 patients with sporadic FTLD (including bvFTD, semantic and nonfluent PPA, PSPs, CBS, and ALS) and 65 patients with genetic FTLD (MAPT, GRN, and C9orf72 mutati will be enrolled. The study also plans to enroll 120 subjects who are members of families carrying FLTD-associated mutations (including 60 mutation carriers). Finally, 100 healthy controls will also be enrolled, including 50 young healthy controls and 50 healthy controls comparable with patients by sex and age. Participants will undergo clinical, neuropsychological, and behavioral assessments, blood and Cerebrospinal fluid (CSF) collection, and multimodal 3Tesla Magnetic Resonance Imaging MRI at baseline and every 6 months for up to 2 years. Primary objectives include mapping longitudinal changes in structural and functional brain networks, developing predictive models of network degeneration and clinical decline, and characterizing protein-specific patterns of network degeneration. Secondary aims include identifying early network biomarkers in presymptomatic carriers and correlating network changes with biological markers.
Studieoversigt
Status
Betingelser
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Lombardy
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Milan, Lombardy, Italien, 20132
- IRCCS San Raffaele
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
Adult participants, under 85 years of age, diagnosed with bvFTD, semantic variant PPA, non-fluent variant PPA, PSP, CBS, and early-stage ALS, according to the criteria of Rascovsky (2011), Gorno-Tempini (2011), Litvan (1996), Armstrong (2013), and Brooks (2000), respectively;
Participants with genetic forms of FTLD associated with mutations in the c9orf72, GRN, MAPT genes, and asymptomatic family members related to FTLD patients carrying such mutations
Healthy participants (age between 20 and 30 years old); Healthy participants matched to patients for age and sex
Exclusion Criteria:
- Participants with a history of other neurological and/or psychiatric disorders, head trauma, alcohol or psychoactive substance use, or a family history of other neurodegenerative diseases.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Diagnostisk
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Participants with the spectrum of FTLD, asymptomatic familiar, healthy elderly and young controls
Partecipants affected by behavioral variant of FTLD (bvFTD), primary progressive aphasia (PPA), semantic variant of PPA (svPPA), non-fluent variant of PPA (nfvPPA), progressive supranuclear paralysis (PSP), corticobasal syndrome (CBS), amyotrophic lateral sclerosis (ALS), genetic and sporadic FTLD.
Asymptomatic familiar.
Healthy elderly and young controls.
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3 Tesla MRI examination without contrast medium in which resting functional MRI sequences, diffusion-weighted sequence, structural MRI sequences will be obtained
During the screening/basal visit, a blood sample will be taken to assess the genetic profile of patients, consanguineous family members, and healthy elderly controls.
Objective is to evaluate the major genes that have been shown to play a role in the pathogenesis of FTLD The genes GRN, MAPT, C9orf72, TARDBP, SOD1, FUS, OPTN, VCP will be analyzed.
During the baseline visit, patients will undergo lumbar puncture for the collection of CSF for quantification of biological biomarkers
A neurological evaluation will be conducted in order to be able to exclude from the study all participants with a history of psychiatric illness, head injury, alcohol or psychotropic substance use
A neuropsychological assessment will be conducted in order to be able to exclude from the study all participants with a history of psychiatric illness, alcohol or psychotropic substance use
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Longitudinal change in the structural connectome via Neurite Orientation Dispersion and Density Imaging (NODDI)
Tidsramme: 6 months, 12 months, 18 months, 24 months
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Evaluating structural white matter integrity over time through graph-theoretical analysis based on NODDI-derived metrics
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6 months, 12 months, 18 months, 24 months
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Longitudinal change in the structural connectome via Diffusion Tensor Imaging (DTI)
Tidsramme: 6 months, 12 months, 18 months, 24 months
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Evaluating structural white matter integrity over time through graph-theoretical analysis
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6 months, 12 months, 18 months, 24 months
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Longitudinal change in brain functional connectome via functional MRI
Tidsramme: 6 months, 12 months, 18 months, 24 months
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Evaluating functional brain changes in functional brain networks using graph-theoretical analysis of fMRI-derived connectivity
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6 months, 12 months, 18 months, 24 months
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Prediction of pathological spreading through the structural connectome
Tidsramme: 6 months, 12 months, 18 months, 24 months
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To predict spatial and temporal spreading of neurodegeneration through the structural connectome using network diffusion model
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6 months, 12 months, 18 months, 24 months
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Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Studieleder: Prof. Massimo Filippi, IRCCS San Raffaele
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Neurologiske manifestationer
- Hjernesygdomme
- Sygdomme i centralnervesystemet
- Sygdomme i nervesystemet
- Psykiske lidelser
- Neuromuskulære sygdomme
- Metaboliske sygdomme
- Neuroadfærdsmæssige manifestationer
- Neurokognitive lidelser
- Øjensygdomme
- Demens
- Tauopatier
- Bevægelsesforstyrrelser
- Basal Ganglia Sygdomme
- Sygdomme i kranienerve
- Rygmarvssygdomme
- TDP-43 Proteinopatier
- Proteostase mangler
- Motor neuron sygdom
- Kommunikationsforstyrrelser
- Oftalmoplegi
- Øjenmotilitetsforstyrrelser
- Lammelse
- Sprogforstyrrelser
- Afasi
- Taleforstyrrelser
- Patologiske tilstande, tegn og symptomer
- Ernæringsmæssige og metaboliske sygdomme
- Tegn og symptomer
- Amyotrofisk lateral sklerose
- Neurodegenerative sygdomme
- Afasi, Primær Progressiv
- Supranuklear parese, progressiv
- Undersøgelsesteknikker
- Håndtering af eksemplar
- Kliniske laboratorieteknikker
- Diagnostiske teknikker og procedurer
- Diagnose
- Punkteringer
- Kirurgiske procedurer, operative
- Sundhedstjenester
- Sundhedsfaciliteter Arbejdsstyrke og tjenester
- Forebyggende sundhedsydelser
- Genetiske teknikker
- Genetiske tjenester
- Diagnostiske tjenester
- Genetisk test
- Blodprøveopsamling
Andre undersøgelses-id-numre
- StG-2016_714388_NeuroTRACK_
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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Kliniske forsøg med Amyotrofisk lateral sklerose (ALS)
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Synchron, Inc.RekrutteringALS (amyotrofisk lateral sklerose) | Motor neuron sygdom | ALS | Neurologisk lidelse | ALS - Amyotrofisk lateral skleroseForenede Stater
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University of TriesteRekrutteringALS (amyotrofisk lateral sklerose) | ALSItalien
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ViomeUniversidade Federal de Santa CatarinaIkke rekrutterer endnuALS (amyotrofisk lateral sklerose) | ALS
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Northwestern UniversityAfsluttetAmyotrofisk lateral sklerose (ALS) | Lou Gehrigs sygdom | Primær lateral sklerose (PLS) | Familiær amyotrofisk lateral sklerose | ALS med frontotemporal demens (ALS/FTD) | Motor neuron sygdom (MND) | Sporadisk ALS (SALS)Forenede Stater
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Inflammasome TherapeuticsIkke rekrutterer endnuALS (amyotrofisk lateral sklerose) | ALS | Neuro-degenerativ sygdom | Neuro-degenerative sygdomme | Motor neuron sygdom (MND)
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ALS Therapy Development InstituteRekrutteringALS (amyotrofisk lateral sklerose) | Motor neuron sygdom | Amyotrofisk lateral sklerose | Motorneuronsygdom, amyotrofisk lateral sklerose | ALS med frontotemporal demens (ALS/FTD)Forenede Stater
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Gipfel Life Sciences GmbHIkke rekrutterer endnu
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Washington University School of MedicineBiogenRekruttering
Kliniske forsøg med 3 Tesla MRI without contrast medium
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Henry Ford Health SystemTrukket tilbage
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Centre Francois BaclesseAktiv, ikke rekrutterendeProtonterapi | Godartede hjernetumorerFrankrig
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Vanderbilt-Ingram Cancer CenterNational Cancer Institute (NCI)AfsluttetOsteosarkom | Ewing Sarkom | Pagets sygdomForenede Stater
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University Hospital Inselspital, BerneRekrutteringCerebrale småkarsygdomme | Intracerebral blødning | CAA - Cerebral Amyloid AngiopatiSchweiz
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IRCCS San RaffaeleTilmelding efter invitationMild kognitiv svækkelse (MCI) | Alzheimers sygdom | Sunde emner | Lewy Body Demens (LBD) | Mild Alzheimers sygdom | Frontotemporal demens (FTD)Italien
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Vanderbilt-Ingram Cancer CenterNational Cancer Institute (NCI)AfsluttetAnaplastisk astrocytom hos voksne | Anaplastisk ependymom hos voksne | Voksen Anaplastisk Oligodendrogliom | Voksen kæmpecelleglioblastom | Voksen glioblastom | Gliosarkom hos voksne | Tilbagevendende voksen hjernetumorForenede Stater
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University of CincinnatiAktiv, ikke rekrutterendeProstatakræftForenede Stater
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Asklepios Kliniken Hamburg GmbHAfsluttetTyktarmskræft Levermetastase | Kontrast forbedrer intraoperativ ultralyd | Billedbehandling for leverkræft | Billeddiagnostik for levermetastaseTyskland
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Massachusetts General HospitalAfsluttet