- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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.
Studieöversikt
Status
Betingelser
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Lombardy
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Milan, Lombardy, Italien, 20132
- IRCCS San Raffaele
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Diagnostisk
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: 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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Longitudinal change in the structural connectome via Neurite Orientation Dispersion and Density Imaging (NODDI)
Tidsram: 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)
Tidsram: 6 months, 12 months, 18 months, 24 months
|
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
Tidsram: 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
Tidsram: 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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Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Studierektor: Prof. Massimo Filippi, IRCCS San Raffaele
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Neurologiska manifestationer
- Hjärnsjukdomar
- Sjukdomar i centrala nervsystemet
- Sjukdomar i nervsystemet
- Mentala störningar
- Neuromuskulära sjukdomar
- Metaboliska sjukdomar
- Neurobehavioral manifestationer
- Neurokognitiva störningar
- Ögonsjukdomar
- Demens
- Tauopatier
- Rörelsestörningar
- Basala ganglia sjukdomar
- Kranial nervsjukdomar
- Ryggmärgssjukdomar
- TDP-43 Proteinopatier
- Proteostasbrister
- Motorneuronsjuka
- Kommunikationsstörningar
- Oftalmoplegi
- Okulära motilitetsstörningar
- Förlamning
- Språkstörningar
- Afasi
- Talstörningar
- Patologiska tillstånd, tecken och symtom
- Närings- och metabola sjukdomar
- Tecken och symtom
- Amyotrofisk lateral skleros
- Neurodegenerativa sjukdomar
- Afasi, Primär progressiv
- Supranukleär pares, progressiv
- Undersökningstekniker
- Provhantering
- Kliniska laboratorietekniker
- Diagnostiska tekniker och procedurer
- Diagnos
- Punktering
- Kirurgiska ingrepp, operativ
- Vårdtjänster
- Sjukvårdsanläggningar och tjänster
- Förebyggande hälsovårdstjänster
- Genetiska tekniker
- Genetiska tjänster
- Diagnostiska tjänster
- Genetisk testning
- Blodprovsamling
Andra studie-ID-nummer
- StG-2016_714388_NeuroTRACK_
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