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.
調査の概要
状態
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究場所
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Lombardy
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Milan、Lombardy、イタリア、20132
- IRCCS San Raffaele
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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.
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:診断
- 割り当て:なし
- 介入モデル:単一グループの割り当て
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的: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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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Longitudinal change in the structural connectome via Neurite Orientation Dispersion and Density Imaging (NODDI)
時間枠: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)
時間枠: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
時間枠: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
時間枠: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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協力者と研究者
スポンサー
協力者
捜査官
- スタディディレクター:Prof. Massimo Filippi、IRCCS San Raffaele
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
- 神経症状
- 脳疾患
- 中枢神経系疾患
- 神経系疾患
- 精神障害
- 神経筋疾患
- 代謝疾患
- 神経行動学的症状
- 神経認知障害
- 目の病気
- 認知症
- タウオパシー
- 運動障害
- 大脳基底核疾患
- 脳神経疾患
- 脊髄疾患
- TDP-43 タンパク病
- プロテオスタシス欠損症
- 運動神経の病気
- コミュニケーション障害
- 眼筋麻痺
- 眼球運動障害
- 麻痺
- 言語障害
- 失語症
- 言語障害
- 病理学的状態、徴候および症状
- 栄養および代謝疾患
- 徴候と症状
- 筋萎縮性側索硬化症
- 神経変性疾患
- 失語症、一次進行性
- 核上性麻痺、進行性
- 調査手法
- 標本処理
- 臨床検査技術
- 診断技術と手順
- 診断
- パンク
- 外科的処置、手術
- 医療サービス
- 医療施設の労働力とサービス
- 予防保健サービス
- 遺伝的技術
- 遺伝的サービス
- 診断サービス
- 遺伝子検査
- 血液標本コレクション
その他の研究ID番号
- StG-2016_714388_NeuroTRACK_
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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