[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"ftd\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:ftd":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,49,92,130,158,189,214,242,272],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":32,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100642440","temporal-interference-stimulation-treatment-in-patients-with-cognitive-impairment-100642440",false,"NCT07643363","Temporal Interference Stimulation Treatment in Patients With Cognitive Impairment","A Randomized, Sham-Controlled Trial of Temporal Interference Stimulation Treatment in Patients With Cognitive Impairment","TIS","Inclusion Criteria:\n\n* meets the criteria for probable AD and MCI due to AD as defined by the 2024 National Institute on Aging-Alzheimer's Association (NIA-AA) guidelines;\n* Positive amyloid biomarker (amyloid PET or CSF tTau\u002FAβ 42);\n* Positive tau biomarker (tau-PET or CSF pTau181);\n* AD-related standard treatments (acetyl cholinesterase inhibitors and N-methyl-D-aspartate receptor antagonists) taken at a stable dose for at least 12 weeks prior to baseline.\n* meets the criteria for probable bvFTD as defined by the revised diagnostic criteria for the behavioural variant of frontotemporal dementia (2011), or PPA as defined by the Classification of primary progressive aphasia and its variants (2011);\n* Optional genetic confirmation of FTD-related pathogenic mutations (if available).\n* Aged between 45 and 85 years, inclusive; no gender limitation.\n* Right-handed.\n* Education level ≥ 3 years.\n* Mini-Mental State Examination (MMSE) score ≥ 11.\n* Clinical Dementia Rating (CDR) score of 1 or 2.\n* with a reliable caregiver\n* Able to cooperate with cognitive assessments and cognitive training procedures.\n* Full understanding of the study, voluntary participation, and provision of written informed consent approved by the Ethics Committee.\n\nExclusion Criteria:\n\n* Diagnosis of other types of dementia or major neurological disorders (e.g., stroke, epilepsy, Lewy body dementia, vascular dementia, Parkinson's disease dementia, Huntington's disease).\n* Major psychiatric disorders such as severe depression or anxiety.\n* Severe systemic or organ dysfunction (e.g., heart failure III-IV, liver cirrhosis, renal failure).\n* Use of medications that significantly affect cognition (e.g., anticholinergics, sedatives), unless approved by the physician.\n* Presence of metal implants incompatible with MRI or TIS (e.g., pacemakers, deep brain stimulators).\n* Skull defects or cranial abnormalities.\n* Inability to tolerate EEG or head stabilization.\n* Severe visual or hearing impairment preventing task performance.\n* History of alcohol or drug abuse.\n* Participation in another clinical trial within the past 3 months.\n* Current or recent treatment with anti-amyloid monoclonal antibodies (e.g., lecanemab, donanemab).","ALL","45 Years","85 Years",{"count":21,"type":22},60,"ESTIMATED","INTERVENTIONAL",[25],"NA","This study aims to evaluate the efficacy and safety of temporal interference stimulation (TIS), a non-invasive neuromodulation technique, in improving cognitive function in patients with cognitive impairment. TIS uses two high-frequency currents applied transcranially, which intersect within the brain to generate a low-frequency modulation field. This technique selectively modulates deep brain regions while minimizing the stimulation of superficial cortical layers.\n\nParticipants will undergo individualized MRI-based modeling to determine the optimal electrode placement and stimulation parameters. The intervention consists of 10 stimulation sessions over a period of 14 days, using either active TIS or sham stimulation. Cognitive assessments, EEG recordings, and functional MRI scans will be conducted at baseline; 5 days after intervention initiation; at the end of the 10-day intervention; and during follow-up assessments at 4 weeks, 8 weeks, and 12 weeks post-intervention to evaluate both immediate and long-term effects on cognitive performance and neural activity.\n\nThe study aims to determine whether TIS can serve as a feasible and effective neuromodulation strategy for individuals with cognitive impairment.",[28,29,30,31],"Amnestic Mild Cognitive Impairment - aMCI","AD-MCI","AD - Alzheimer's Disease","FTD",[33,34,35],"Temporal Interference Stimulation","Alzheimer's Disease","Frontotemporal Dementia","RECRUITING","2026-06-08",{"date":39,"type":40},"2026-06-11","ACTUAL",{"date":42,"type":22},"2026-07-01",{"date":44,"type":22},"2029-06",{"name":46,"class":47},"Tianjin Huanhu Hospital","OTHER",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":17,"minAge":57,"maxAge":58,"enrollmentInfo":59,"targetDuration":4,"studyType":23,"phases":61,"briefSummary":64,"conditions":65,"keywords":68,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":91},"100521076","phase-1-a-study-to-evaluate-the-safety-and-effect-of-avb-101-a-gene-therapy-product-in-subjects-with-a-genetic-sub-type-of-frontotemporal-dementia-ftd-grn-100521076","NCT06064890","A Study to Evaluate the Safety and Effect of AVB-101, a Gene Therapy Product, in Subjects With a Genetic Sub-type of Frontotemporal Dementia (FTD-GRN)","A Phase 1\u002F2 Open-Label, Ascending Dose, Multicenter Study to Evaluate the Safety and Preliminary Efficacy of AVB-101 Administered by Bilateral Intrathalamic Infusion in Subjects With Frontotemporal Dementia With Progranulin Mutations (FTD-GRN)","ASPIRE-FTD","Inclusion Criteria:\n\n* Male or female, 30 to 75 years of age\n* Carriers of a pathogenic GRN mutation\n* FTD as evidenced by CDR + NACC FTLD global score of 0.5, 1.0, or 2.0\n* Presence of 1 or more of the criteria for diagnosis of possible bvFTD or PPA\n* Able and willing to comply with all procedures and the study visit schedule\n* Able and willing to give written informed consent prior to study participation, and agree to designate a legal representative to act on their wishes to continue participation should they lose capacity to consent at some point during the study OR If, in the Investigator's opinion, the subject lacks capacity to consent, written informed consent of their legal representative must be obtained in accordance with local laws, regulations, and\u002For customs. In countries where local laws, regulations, and\u002For customs do not permit subjects who lack capacity to consent to participate in this study, these subjects will not be enrolled\n* An identified, informed study partner who is able and willing to support the participant in the study and to provide assessments of the participant during the study\n\nExclusion Criteria:\n\n* Severe dementia, defined as CDR + NACC FTLD global score of 3.0, or other symptoms that preclude the ability to comply with study procedures and\u002For pose unacceptable safety risk to the subject\n* Any concurrent disease that may cause cognitive impairment unrelated to mutations in the GRN gene, such as other causes of dementia, neurosyphilis, hydrocephalus, stroke, small vessel ischemic disease, uncontrolled hypothyroidism, or vitamin B12 deficiency\n* Clinically significant abnormality on MRI at Screening considered to be a contraindication to Intrathalamic infusion\n* Surgically significant pattern of brain atrophy on MRI at Screening that interferes with planned neurosurgical trajectory\n* Previous treatment with any gene or cell therapy\n* Previous treatment with any investigational medicinal product (IMP) within 60 days or 5 half-lives (whichever is longer) prior to study drug treatment\n* Concomitant disease, any clinically significant laboratory abnormality, or treatment which, in the opinion of the Investigator, may pose an unacceptable safety risk to the participant or interfere with study conduct or the participant's ability to comply with study procedures including neurosurgical administration under anesthesia","30 Years","75 Years",{"count":60,"type":22},18,[62,63],"PHASE1","PHASE2","The goal of this clinical study is to learn about an investigational gene therapy product called AVB-101, which is designed to treat a disease called Frontotemporal Dementia with Progranulin Mutations (FTD-GRN). FTD-GRN is an early-onset form of dementia, a progressive brain disorder that affects behavior, language and movement. These symptoms result from below normal levels of a protein called progranulin (PGRN) in the brain, which leads to the death of nerve cells (neurons), affecting the brain's ability to function.\n\nThe main questions that the study aims to answer are:\n\n1. Is a one-time treatment with AVB-101 safe for patients with FTD-GRN?\n2. Does a one-time treatment with AVB-101 restore PGRN levels to at least normal levels?\n3. Could AVB-101 work as a treatment to slow down or stop progression of FTD-GRN?\n\nIn this study there is no placebo (a dummy pill or treatment used for comparison purposes), so all participants will receive a one-time treatment of AVB-101 delivered directly to the brain, with follow-up assessments for 5 years.",[35,31,66,67],"FTD-GRN","Dementia, Frontotemporal",[69,70,71,72,73,74,75,76,77,78,79,80],"Gene Therapy","AAV","Intrathalamic","Intraparenchymal","Progranulin","Behavioral Variant FTD","Primary Progressive Aphasia","PGRN","Granulin","Dementia","Dementia Gene Therapy","AAV9","2026-04-07",{"date":83,"type":40},"2026-04-13",{"date":85,"type":40},"2023-08-30",{"date":87,"type":22},"2030-03-21",{"name":89,"class":90},"AviadoBio Ltd","INDUSTRY",19,{"id":93,"slug":94,"hasResults":11,"nctId":95,"briefTitle":96,"officialTitle":96,"acronym":97,"eligibilityCriteria":98,"healthyVolunteers":11,"sex":17,"minAge":99,"maxAge":4,"enrollmentInfo":100,"targetDuration":4,"studyType":102,"phases":4,"briefSummary":103,"conditions":104,"keywords":110,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":129},"100581941","disease-biosignatures-in-alsftd-spectrum-new-impactful-biological-perspectives-beyond-clinical-approaches-100581941","NCT06856850","Disease Biosignatures in ALS\u002FFTD Spectrum: New Impactful Biological Perspectives Beyond Clinical Approaches","SPECTRALS","Inclusion Criteria:\n\n* Clinical criteria for ALS (Brooks et al., 2000; de Carvalho M., 2008), FTD (GornoTempini et al., 2011; Rascovsky et al., 2011)\n\nExclusion Criteria:\n\n* na","18 Years",{"count":101,"type":22},230,"OBSERVATIONAL","Diagnosis of ALS\u002FFTD disease spectrum is challenging because it largely relies on clinical symptoms. Identifying novel biomarkers is essential for a paradigm shift towards a more precise biological-based diagnosis. To achieve this aim, having access to proper specimens and analytical methods is crucial. Our team of experts in neurology, biology, chemistry, physics, and AI will explore ALS\u002FFTD from novel perspectives using transcriptomics, proteomics, genomics and other innovative approaches to analyzing easily accessible tissues. The seed amplification assay (SAA) will be also exploited to detect pathological TDP-43. This project aims to create disease fingerprints useful for patient stratification and monitoring of disease progression, and to evaluate the therapeutic efficacy in clinical trials, thus overcoming the limits of clinical interpretation. Discovering new biomarkers and cellular pathways will improve the diagnosis and treatment of these devastating diseases.",[105,31,106,107,108,109],"ALS (Amyotrophic Lateral Sclerosis)","Neuropathic","Psychiatric Disorders","Idiopathic Intracranial Hypertension","Frontotemporal Dementia (FTD)",[111,112,113,114,115,116,117,118,119],"Amyotrophic lateral sclerosis","frontotemporal dementia","microbiota","miRNA","protein-NMR","TDP-43","endocytic disfunction","seed amplification assay","peripheral biomarker","2026-03-25",{"date":122,"type":40},"2026-03-30",{"date":124,"type":40},"2025-02-27",{"date":126,"type":22},"2026-08",{"name":128,"class":47},"Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta",4,{"id":131,"slug":132,"hasResults":11,"nctId":133,"briefTitle":134,"officialTitle":134,"acronym":135,"eligibilityCriteria":136,"healthyVolunteers":11,"sex":17,"minAge":99,"maxAge":4,"enrollmentInfo":137,"targetDuration":4,"studyType":23,"phases":139,"briefSummary":140,"conditions":141,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":150,"startDateStruct":152,"completionDateStruct":154,"leadSponsor":156,"locationsCount":48},"100617268","repetitive-transcranial-magnetic-stimulation-in-frontotemporal-lobar-degeneration-100617268","NCT07316413","Repetitive Transcranial Magnetic Stimulation in Frontotemporal Lobar Degeneration","FTLD_rTMS","Inclusion Criteria:\n\n* diagnosis of FTLD (bvFTD, avPPA, svPPA, CBS, or PSP)\n* global CDR plus NACC FTLD ≤ 1\n\nExclusion Criteria:\n\n* presence of cerebrovascular disease, hydrocephalus, intracranial masses identified by MRI, history of head trauma, serious medical conditions unrelated to FTLD, history of epilepsy, and presence of electronic (e.g., pacemaker) or metallic implants in the head.",{"count":138,"type":22},120,[25],"The aim of the study is to evaluate the safety, feasibility, clinical and biological efficacy, and predictors of efficacy of an intervention consisting of repetitive transcranial magnetic stimulation (rTMS) in patients with frontotemporal dementia (FTLD) or in asymptomatic persons at risk of FTLD (i.e., persons familiar with FTLD patients).\n\nrTMS is a non-invasive brain stimulation technique, and has demonstrated the ability to modulate neuronal activity by applying high-frequency magnetic fields to the surface of the skull. rTMS offers a potentially effective means to influence neural networks involved in the pathogenesis of neurodegenerative diseases, with benefits that could extend beyond symptomatic relief. Its safety has been widely documented in a variety of clinical conditions, making it an ideal candidate for application in neurodegenerative diseases.\n\nIn the present study, participants will undergo the following procedures: (i) clinical and neuropsychological assessment, (ii) TMS, and (iii) blood sampling. The occurrence of adverse events will be monitored throughout the duration of the study.\n\nThe study is structured in two phases. In the first phase, double-blind, randomised and placebo-controlled, participants will be randomised into two groups: group 1, participants will receive real rTMS for 2 weeks; and group 2, placebo rTMS for 2 weeks. In the second, open-label phase, after 10 weeks, both group 1 and group 2 participants will receive real rTMS for 2 weeks. Each participant will receive a total of 4 weeks of intervention (4 weeks of real stimulation in group 1, or 2 weeks of real stimulation and 2 weeks of placebo stimulation in group 2), with 5 sessions per week (Monday to Friday) lasting approximately 30 minutes each.\n\nVisits will take place at the beginning of the study (T00) and after 2 weeks (T02, end of the first phase), 12 weeks (T12, beginning of the second phase), 14 weeks (T14, end of the second phase), 24 weeks (T24, follow-up). During each visit, participants underwent the following procedures: (i) clinical and neuropsychological assessment, (ii) blood sampling, and (iii) TMS. Specific biomarker analyses will be performed on the blood samples to study the pathophysiological mechanisms of the disease and the effect of the experimental intervention.",[142,31,143,144,145,146,147,148],"FTLD","bvFTD","PPA","PSP","Cortical Basal Syndrome (CBS)","rTMS","Theta Burst Stimulation","2025-12-18",{"date":151,"type":40},"2026-01-05",{"date":153,"type":40},"2025-02-13",{"date":155,"type":22},"2029-02-01",{"name":157,"class":47},"Università degli Studi di Brescia",{"id":159,"slug":160,"hasResults":11,"nctId":161,"briefTitle":162,"officialTitle":162,"acronym":163,"eligibilityCriteria":164,"healthyVolunteers":11,"sex":17,"minAge":99,"maxAge":4,"enrollmentInfo":165,"targetDuration":4,"studyType":102,"phases":4,"briefSummary":167,"conditions":168,"keywords":173,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":180,"lastUpdatePostDateStruct":181,"startDateStruct":183,"completionDateStruct":185,"leadSponsor":187,"locationsCount":48},"100611017","omics-sciences-for-the-identification-of-pathogenetic-mechanisms-and-biomarkers-in-neurodegenerative-diseases-100611017","NCT07235111","Omics Sciences for the Identification of Pathogenetic Mechanisms and Biomarkers in Neurodegenerative Diseases","NeurOmics","Inclusion Criteria\n\n• Patients suffering from neurodegenerative diseases\n\nExclusion Criteria\n\n• Patients not suffering from neurodegenerative diseases",{"count":166,"type":22},1200,"The study aims to use 'omics' sciences, employing the most advanced technologies currently available, in order to identify pathogenic genomic variants, proteins and\u002For altered molecular pathways in neurodegenerative diseases and to obtain a new and more complete characterisation of subjects affected by the neurodegenerative diseases under study. Thanks to the integration of genomic, gene expression (transcriptomic and epigenomic), protein and metabolic data and clinical data, the study also aims to identify new markers for the diagnosis, prognosis, also in terms of response to therapy, and monitoring of neurodegenerative diseases.\n\nThe study involves the enrolment of at least 1.200 individuals with neurodegenerative disease.",[169,31,170,171,172,105],"Alzheimer Disease","Young-onset Dementia","MCI","Parkinson Disease",[174,175,176,177,178,179],"LEWY BODIES DISEASE","young-onset dementia","alzheimer","parkinson","als","mci","2025-11-20",{"date":182,"type":40},"2025-11-25",{"date":184,"type":40},"2025-02-28",{"date":186,"type":22},"2039-09-17",{"name":188,"class":47},"Ospedale Policlinico San Martino",{"id":190,"slug":191,"hasResults":11,"nctId":192,"briefTitle":193,"officialTitle":193,"acronym":194,"eligibilityCriteria":195,"healthyVolunteers":196,"sex":17,"minAge":99,"maxAge":4,"enrollmentInfo":197,"targetDuration":4,"studyType":23,"phases":199,"briefSummary":200,"conditions":201,"keywords":4,"overallStatus":204,"whyStopped":4,"lastUpdateSubmitDate":205,"lastUpdatePostDateStruct":206,"startDateStruct":208,"completionDateStruct":210,"leadSponsor":212,"locationsCount":4},"100600667","metabolic-characterization-of-alzheimers-disease-and-frontotemporal-dementia-by-23na-mri-and-fdg-pet-100600667","NCT07100470","Metabolic Characterization of Alzheimer's Disease and Frontotemporal Dementia by 23Na-MRI and FDG-PET","MetaAD_FTD","Inclusion Criteria:\n\n* Patients with Alzheimer's disease\n\n  * CDR (Clinical Dementia Rating Scale) = 0.5 or 1\n  * Progressive amnestic syndrome, associated or not with other cognitive impairments\n  * Biological criteria: CSF biomarkers suggestive of AD-continuum (Jack et al., 2018)\n* Patients with FTD\n\n  * Modifications of the personality and the social conducts in the foreground (behavioral variant) (Rascovsky et al., 2011)\n  * Primary progressive aphasia (Gorno-Tempini et al., 2011):\n\n    * Effortful, agrammatic speech plus at least one of: a) impaired grammar\u002Fsentence comprehension with relatively preserved single word comprehension, or b) groping, distorted speech production (apraxia of speech)\n    * Semantic language disorders\n  * Compatible brain imaging: profile of atrophy and\u002For hypometabolism on FDG-PET (or hypoperfusion on SPECT) compatible with the diagnosis of FTD and\u002For absence of atypia\n  * Biological criteria: No AD profile on CSF biomarkers if available; if CSF not available: diagnosis based on clinical criteria left to the judgment of the investigators\n* Cognitively healthy controls\n\n  * Absence of known psychiatric disorder\n  * Score on the Folstein Mini-Mental State Examination (MMSE \\> or = 27) with no more than one word missing\n  * Normal neuropsychological assessment for the age and the educational level, particularly Scores on the Free and Cued Selective Reminding Test (FCSRT) of \\>25 for free recall and \\>44 for total recall.\n\nExclusion Criteria:\n\n* Subject with an evolving and\u002For badly checked psychiatric pathology (left to the judgment of the investigator).\n* Subject with a grave, severe or unstable pathology (left to the judgment of the investigator) the nature of which can interfere with the variables of evaluation.\n* Epileptic subjects, with poor tolerance to MRI (1.5T, 3T or 7T),\n* Subject presenting contraindications to the MRI such as Pacemaker or stimulating neurosensory or implantable defibrillator, cochlear implants, eye or cerebral ferromagnetic foreign bodies close to nervous structures, metallic prostheses, neurosurgical ventriculoperitoneal shunt valves\n* Known or supposed histories (\\\u003C or = 5 years) of severe alcoholism or misuse of drugs\n* Vascular, inflammatory or expansive, lesion visible on the MRI which can interfere with the criteria of diagnosis.\n* No health insurance\n* Agitation of the patient: not cooperative or agitated patients, claustrophobic subjects",true,{"count":198,"type":22},55,[25],"Alzheimer's disease (AD) and frontotemporal dementia (FTD) are the most common forms of neurodegenerative dementia. However, their differential and timely diagnosis can be challenging for clinicians, therefore often closing the door for an early and possibly successful treatment before irreversible cerebral damage occurs. Hence, treatment options often become available only at a late point in time. In Alzheimer's disease, early neuroimaging markers are glucose hypometabolism and Amyloid-\u002FTau-depositions (PET). Recent findings from sodium magnetic resonance imaging (23Na-MRI) point to brain tissue sodium concentration as a metabolic marker of AD progression. Sodium is crucial for neurotransmission and cellular homeostasis maintained by the cellular Na+\u002FK+-ATPase, depending on Adenosine-Triphosphate as energy source from the mitochondrial respiratory chain, also interacting with tau and amyloid. In this project, we aim to characterize disease-specific metabolic patterns in AD vs. FTD by performing 23Na-MRI in association to FDG-PET to support early positive and differential diagnosis and therapeutic follow-up in both diseases in association to clinical parameters such as CSF\u002Fblood markers and neuropsychological assessment. Assessment of 7T MRI including 23Na-MRI, 31P-MRS and 1H-MRI is planned with analysis of results in association with FDG-PET, Amyloid- and Tau-PET, blood and CSF biomarkers as well as neuropsychological and clinical assessment.",[31,202,203],"AD","Healthy Controls","NOT_YET_RECRUITING","2025-07-28",{"date":207,"type":40},"2025-08-03",{"date":209,"type":22},"2025-10-01",{"date":211,"type":22},"2029-03-01",{"name":213,"class":47},"Centre Hospitalier St Anne",{"id":215,"slug":216,"hasResults":11,"nctId":217,"briefTitle":218,"officialTitle":219,"acronym":220,"eligibilityCriteria":221,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":222,"enrollmentInfo":223,"targetDuration":4,"studyType":23,"phases":224,"briefSummary":225,"conditions":226,"keywords":229,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":232,"lastUpdatePostDateStruct":233,"startDateStruct":235,"completionDateStruct":237,"leadSponsor":239,"locationsCount":241},"100435185","neurofilament-light-chains-and-cognitive-impairment-in-chronic-psychiatric-disease-100435185","NCT04946916","Neurofilament Light Chains and Cognitive Impairment in Chronic Psychiatric Disease","Validation of Serum Neurofilament Light Chain as a Biomarker to Differentiate Cognitive Impairment From Neurodegenerative or Psychiatric Diseases","Nfl_COG","Inclusion Criteria:\n\n* haven given written consent\n\nParticipants with psychiatric conditions:\n\n* Schizophrenia (DSM-V criteria) with or without cognitive involution\n* Bipolar disorder (DSM-V criteria) with or without cognitive involution\n\nParticipants with neurodegenerative disease:\n\n* probable or definite FTD (Rascovsky criteria 2011)\n* Biological Alzheimer's disease with typical CSF (NIA-AA 2011)\n\nExclusion Criteria:\n\n* Uninterviewable patient and\u002For missing history\n* History of recent or previous head trauma with loss of consciousness\n* History of ischemic or hemorrhagic stroke\n* Chronic alcoholism \u002F chronic drug use\n* Progressive somatic pathology \u002F severe metabolic disorder \u002F poorly controlled epilepsy\n* Age \\\u003C 45 years\n* Age \\> 80 years\n* Electroconvulsive therapy for less than 6 months","80 Years",{"count":138,"type":22},[25],"The validation of biomarkers allowing the discrimination of cognitive and behavioral disorders of psychiatric origin from those of neurodegenerative origin would facilitate diagnosis and improve patient management. Neurofilaments, which are markers of neuronal lysis, appear to be a promising biomarker. In a previous preliminary study, the investigators demonstrated significantly lower concentrations of neurofilaments in CSF of psychiatric patients compared to neurodegenerative diseases.\n\nThe main objective of this study is to validate the plasma assay of neurofilament light chain as a biomarker for the differential diagnosis of psychiatric or neurodegenerative cognitive impairment. Other biomarkers of interest (Tau, TDP-43, GFAP and UCH-L1) will also be analyzed.\n\nA sub-part of this study will also focus on the retrospective analysis of the CSF\u002FPlasma correlations of the different biomarkers mentioned above from tube bottom samples taken in routine care.",[227,228,169,31],"Schizophrenia","Bipolar Disorder",[230,231],"dementia","biomarker","2025-07-23",{"date":234,"type":40},"2025-07-24",{"date":236,"type":40},"2021-10-22",{"date":238,"type":22},"2028-03-22",{"name":240,"class":47},"Hôpital le Vinatier",2,{"id":243,"slug":244,"hasResults":11,"nctId":245,"briefTitle":246,"officialTitle":247,"acronym":248,"eligibilityCriteria":249,"healthyVolunteers":11,"sex":17,"minAge":99,"maxAge":4,"enrollmentInfo":250,"targetDuration":4,"studyType":23,"phases":252,"briefSummary":253,"conditions":254,"keywords":256,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":262,"lastUpdatePostDateStruct":263,"startDateStruct":265,"completionDateStruct":267,"leadSponsor":269,"locationsCount":271},"100496320","phase-2-nabilone-for-agitation-in-frontotemporal-dementia-100496320","NCT05742698","Nabilone for Agitation in Frontotemporal Dementia","Double Blind Crossover Clinical Trial of Nabilone for Agitation in Frontotemporal Dementia","Nabilone-FTD","Inclusion Criteria:\n\n* Men and women over 18 years\n* Major neurocognitive disorder due to probable behavioural variant FTD (Rascovsky criteria)17 or primary progressive aphasia (Gorno-Tempini criteria)18. All ages and severity levels will be included.\n* Meets International Psychogeriatric Association criteria for agitation in cognitive disorders19\n* CMAI score of 39 or above\n* Stable psychoactive medication for 2 weeks prior to screening (all medications allowed) with no intention to change dose during treatment period\n* Available study partner with ≥10 hours per week in-person contact with the patient. This can either be a friend\u002Ffamily member or a staff member at an assisted living facility.\n* Capacity to provide written consent in English or French, or consent from official surrogate decision maker in case of incapacity\n\nRationale for Inclusion Criteria: The inclusion criteria are designed to enroll patients with FTD with the behaviours of interest, with a range of disease severity that will permit assessment of all outcome measures.\n\nExclusion Criteria:\n\n* Clinically significant psychotic symptoms (Neuropsychiatric Inventory domain score (severity x frequency) ≥4 on the delusions or hallucinations subscale)\n* Clinically significant orthostatic hypotension (a decrease in systolic blood pressure of 20 mm Hg or in diastolic blood pressure of 10 mm Hg within three minutes of standing compared to blood pressure in a seated position)\n* Symptomatic orthostatic tachycardia (heart rate increase from of at least 30 beats per minute within the first 5 minutes of standing compared to a seated position IF orthostatic hypotension is not a problem)\n* Unstable cardiovascular condition in the opinion of the investigator\n* Known or suspected history of drug or alcohol dependence or abuse in the past 12 months, including use of any psychomimetic drugs (e.g. ketamine, lysergic acid diethylamide, psilocybin).\n* Allergy, or significant adverse reaction to cannabinoids. If the adverse reaction involved psychological symptoms that are indicative of psychosis or severe anxiety the patient will be excluded. Their treating clinician may be consulted for a clinical opinion on the severity of the response to cannabis and whether this justifies exclusion from the trial.\n* Major depressive episode within 6 months of screening\n* Women who are breast feeding or pregnant\n* Severe liver dysfunction, as determined by their treating clinician\n* Other psychiatric or neurological condition that could cause significant agitation\n* Ongoing use of any cannabinoid-related products. This includes any THC or CBD based products, regardless of administration method (oral, inhalation, topical, etc…)\n\nRationale for Exclusion Criteria: The exclusion criteria are designed to avoid inclusion of patients who may have medical comorbidities that would increase their risk of serious side effects from repeated nabilone administration.",{"count":251,"type":22},45,[63],"The primary goal of this study is to test the hypothesis that oral nabilone treatment will reduce agitation compared with placebo in patients with Frontotemporal Dementia (both behavioural variant frontotemporal dementia and primary progressive aphasia). The study population is defined as patients with probable Frontotemporal Dementia that meet the International Psychogeriatric Association criteria for agitation in cognitive disorders.",[35,255,75,143,144,31],"Frontotemporal Dementia, Behavioral Variant",[257,258,259,260,78,261,31],"Nabilone","Nabilone FTD","Agitation","TEVA Nabilone","BvFTD","2025-04-11",{"date":264,"type":40},"2025-04-15",{"date":266,"type":40},"2023-03-07",{"date":268,"type":22},"2026-05",{"name":270,"class":47},"Simon Ducharme, MD",7,{"id":273,"slug":274,"hasResults":11,"nctId":275,"briefTitle":276,"officialTitle":277,"acronym":278,"eligibilityCriteria":279,"healthyVolunteers":196,"sex":17,"minAge":99,"maxAge":4,"enrollmentInfo":280,"targetDuration":281,"studyType":102,"phases":4,"briefSummary":282,"conditions":283,"keywords":285,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":288,"lastUpdatePostDateStruct":289,"startDateStruct":291,"completionDateStruct":293,"leadSponsor":295,"locationsCount":297},"100561826","genetics-and-environment-intersection-in-the-als-ftd-spectrum-an-italian-twins-cohort-study-with-a-multi-omics-approach-100561826","NCT06595212","Genetics and Environment iNtersection In the ALS-FTD Spectrum: an Italian Twins Cohort studY With a Multi-Omics Approach","Genetics and Environment iNtersection In the Amyotrophic Lateral Sclerosis - FrontoTemporal Dementia Spectrum: an Italian Twins Cohort studY With a Multi-Omics Approach","GENIALITY","Inclusion Criteria:\n\n* Age \\>18 yrs\n* Presence of MZ or DZ twins in the family both willing to participate in the study and able to provide informed consent\n* At least one twin is affected by ALS as defined by Gold Coast Criteria (Shefner et al., 2020) and\u002For by FTD as defined by Strong and colleagues (Strong et al., 2017)\n* Subjects able and willing to comply with study procedures as per protocol\n* Subjects able to understand, and capable of providing informed consent at screening visit before any protocol-specific procedures\n\nExclusion Criteria:\n\n* Unwillingness to perform assessments as stated in the protocol at least during baseline visit for both twins\n* Unwillingness to donate biological samples collected at periphery (lumbar puncture excluded) for both twins\n* Women who are pregnant or breastfeeding",{"count":251,"type":22},"24 Months","The goal of this study is to learn from discordant twins affected by Amyotrophic Lateral Sclerosis and\u002For Frontotemporal Dementia the contribution of genetic background versus environmental exposure. The main questions it aims to answer is:\n\n* How far does the genetic background explain the onset of ALS\u002FFTD in discordant twins?\n* Which environmental factors and events occurring in post-fetal life influence the onset or progression of this neurodegenerative condition? Participants with ALS and\u002For FTD with a monozygotic or dizygotic twin willing to contribute to this research will be followed up for two years by specialized Motor Neuron Disorders centers in Italy, donating biological specimen for -omic sciences analysis, and checking out if prodromal signs\u002Fsymptoms of these two conditions will develop during time.",[284,31],"ALS",[284,31,286,287],"twin","cohort","2025-01-31",{"date":290,"type":40},"2025-02-04",{"date":292,"type":40},"2024-01-29",{"date":294,"type":22},"2026-01-30",{"name":296,"class":47},"Azienda Ospedaliero-Universitaria di Modena",3]