Bipolar DisorderDISBANDNCT06706687
A Study of the Behavioral Variant of Frontotemporal Dementia and Bipolar Disorder: a Neuroimaging and Epigenetics Integrated Approach
A study testing DISBAND protocol in people with Bipolar Disorder and Frontotemporal Dementia, Behavioral Variant, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
Trial summary
The aim of this study is to investigate the selective epigenetic modifications and their effect on brain's morphology and functionality in the frontotemporal dementia behavioral variant and bipolar disorder. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bipolar Disorder, Frontotemporal Dementia, Behavioral Variant
- What is being tested?
- DISBAND protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteItaly
- Study dates
- 19 May 2021to Apr 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- byFTD group: patients of either sex; 18 years of age or older; diagnosis of behavioral variant Frontotemporal Dementia according to current diagnostic criteria; presence of a signed informed consent.
- BD group: patients of either sex; 18 years of age or older; diagnosis of bipolar disorder according to DSM-V criteria; presence of a signed informed consent.
- HC group: patients of either sex; 18 years of age or older; subjects who have gone through the same diagnostic process as patients under suspicion of a central nervous system and/or psychiatric disorder, resulting in the absence of cognitive deficits and mood disorders; presence of a signed informed consent.
Who cannot join
- Diagnosis of Alzheimer's disease
- Comorbidities interfering with the studied condition (e.g. other neurological diseases or history of substance or alcohol abuse)
- Diseases with an inflammatory component (e.g. autoimmune diseases, tumors)
- Pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico
Milan, MI, 20100
Paolo Brambilla, Professor, + 39 02 55032717, paolo.brambilla1@unimi.it
About this study
The aim of this study is to investigate the selective epigenetic modifications and their effect on brain's morphology and functionality in the frontotemporal dementia behavioral variant and bipolar disorder. The open-label, multicentric, interventional case-control study involves the analysis of 3 separate cohorts of patients, partly selected over the course of the past 10 years. More specifically, 80 behavioral variant Frontotemporal Dementia (bvFTD) patients (40, of whom 20 carry G4C2 expansion in the C9orf72 gene, are already available, while 40 will be prospectively recruited), 80 Bipolar Disorder (BD) patients (40, including 20 with early onset and 20 with late onset, are already available, while 40 will be prospectively recruited) and 50 healthy control (HC) subjects (20 of whom are already available from other previously approved studies), will be enrolled in this study.
For each participant a blood sample will be collected, processed, and studied in order analyze the expression of miRNA. Every participant will also undergo Nuclear Magnetic Resonance Imaging (NMR), Nuclear Magnetic Resonance Spectroscopy (1H-MRS), and Positron Emission Tomography (PET) and, lastly, a battery of behavioral scales to explore different cognitive domains will be administered to all participants by a team of psychologists and physicians. The overall estimated duration of the study is 36 months.
Read the detailed description
Following the inclusion and exclusion criteria, the participants will be recruited and subdivided into three groups:
- bvFTD patients, followed prospectively for at least 2 years. These include bvFTD carriers of G4C2 expansion in the C9orf72 gene (best model of the two diseases because such expansion is widely associated with the development of psychosis)
- BD patients who are part of a cohort of multi affected families (MAF) followed since January 2017 at the Psychiatry Operating Unit of the Policlinico di Milano and who have positive family history of neurodegenerative diseases.
- Healthy subjects who underwent neurocognitive tests at baseline that excluded the presence of dementia and psychiatric diseases.
The investigators will be collecting participants blood samples, which will be processed and analyzed. More specifically, total exosomes will be isolated from 500 microliters of plasma by ExoQuick precipitation solution (SBI). Isolation and purification of NDEs will be performed by ExoFlow purification kit using biotinylated anti-human CD171 (L1CAM) antibody (clone 5G3, Ebiosciences). Total RNA contained in NDEs will be extracted by Total Exosome RNA and Protein Isolation Kit and miRNA expression analysis by TaqMan OpenArray Human Advanced MicroRNA Panel (Thermo Fisher Scientific). Expression analysis of lncRNAs will be conducted by LincFinder Array and inflammatory and autoimmunity arrays (Qiagen).
The participants will also undergo a neuroimaging session, where structural MRI and 1H-MRS sessions will be performed using a 3T MRI scanner available at the Neuroradiology Unit. The 1H-MRS will provide sensitive and reliable assessment of neurochemical changes in specific brain areas. The acquisition voxels will be palced in the dorso- and ventrolateral prefrontal cortex (DLPFC/VLPFC), amygdala, and hippocampus. Finally, an FDG-PET scan will be performed with a Biograph Truepoint 64 PET/TC scanner. T1-weighted and FDG-PET images will be used to explore brain morphological/metabolic differences between the groups. Gray matter and white matter volumes will be estimated locally and compared between groups using voxel-based morphometry. A parallel region of interest comparison (ROIs) will be performed to estimate regional volumes using the Automated Anatomical Labelling (AAL) atlas as a reference, again focusing on the DLPFC/VLPFC, amygdala and hippocampus. Finally, an additional regional analysis based on Freesurfer software will allow the investigators to estimate the cortical thickness, cortical surface area, and cortical gyrification of the Desikan-Killiany atlas regions. All MRI and PET analyses will be performed in the context of a general linear model using a specific software implementation in MATLAB called Statistical Parametric Mapping (SPM).
Lastly, neuroimaging data and ncRNA expression profiles will be used as predictors in the ML analysis. Given the small sample size, initially linear models (e.g., Support Vector Machine) will be used. Later, to improve the predictive power of our models, the investigators will apply the ML method called random forest, a more versatile and powerful classification algorithm, and the XGBoost (eXtreme Gradient Boosting) algorithm. To avoid overfitting of the learning process, a "grid" search of model hyperparameters will be performed. A 5-fold cross-validation will be used to validate the results, with a split between training-tests of 80%-20%.
- Being tested
- DISBAND protocol
- Keywords
- Bipolar Disorder (BD), Frontotemporal Dementia, Behavioral Variant (bvFTD), Epigenetics, Neuroimaging, miRNA, Nuclear Magnetic Resonance Imaging (NMR), Nuclear Magnetic Resonance Spectroscopy (1H-MRS), Positron Emission Tomography (PET), Healthy controls (HC)
- Medical subject headings
- Bipolar Disorder, Pick Disease of the Brain, Frontotemporal Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DISBAND protocolDiagnostic test
For each participant blood samples will be collected, processed and studied to analyse microRNA expression, more specifically investigating non-coding RNA (ncRNA). Each participant will undergo a multimodal neuroimaging session, composed of structural MRI, 1H-MRS and PET.
| Study group | Role | What they receive |
|---|---|---|
| Frontotemporal Dementia, Behavioral Variant (bvFTD) | Other | Not described Receives: Diagnostic Test: DISBAND protocol |
| Bipolar Disorder (BD) | Other | Not described Receives: Diagnostic Test: DISBAND protocol |
| Healthy controls (HC) | Other | Not described Receives: Diagnostic Test: DISBAND protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of ncRNA transcripts and a specific noncoding RNA profile in neuron-derived exosomes
Identification of ncRNA transcripts and a specific noncoding RNA profile in neuron-derived exosomes in patients with bvFTD and BD
Measured: 36 months
Differences in brain structure in terms of white matter volumes
Evaluation of the differences in brain structure in terms of white matter volumes comparing the three groups, using structural MRI
Measured: 36 months
Differences in brain structure in terms of gray matter volumes
Evaluation of the differences in brain structure in terms of gray matter volumes comparing the three groups, using structural MRI
Measured: 36 months
Differences in brain structure in terms of cortical gyrification
Evaluation of the differences in brain structure in terms of cortical gyrification comparing the three groups, using structural MRI
Measured: 36 months
Differences in brain structure in terms of superficial cortical area
Evaluation of the differences in brain structure in terms of superficial cortical area comparing the three groups, using structural MRI
Measured: 36 months
Differences in brain structure in terms of cortical thickness
Evaluation of the differences in brain structure in terms of cortical thickness comparing the three groups, using structural MRI
Measured: 36 months
Differences in brain metabolism
Evaluation of the differences in brain metabolism comparing the three groups, using FDG/PET
Measured: 36 months
Differences in glutamatergic neurotransmission in the prefrontal-limbic cortex
Evaluation of the differences in the glutamatergic neurotransmission of the prefrontal-limbic cortex, comparing the three groups, using 1H-MRS
Measured: 36 months
Secondary outcomes (1)
Creation of a machine learning model
Creation of a machine learning model that could integrate neuroimaging data and miRNA expression data to validate the best candidates identified combining imaging and epigenetic data
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2024
- Study start19 May 2021
- Primary completionJan 2025 (estimated)
- Study completionApr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elio Scarpini, Professor, Principal investigator, UOSD Malattie Neurodegenerative
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06706687
- Sponsor's protocol ID
- DISBAND
- Acronym
- DISBAND
- Status last verified
- Nov 2024
- First submitted
- 22 Nov 2024
- Last updated
- 26 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Galimberti D, Fenoglio C, Serpente M, Villa C, Bonsi R, Arighi A, Fumagalli GG, Del Bo R, Bruni AC, Anfossi M, Clodomiro A, Cupidi C, Nacmias B, Sorbi S, Piaceri I, Bagnoli S, Bessi V, Marcone A, Cerami C, Cappa SF, Filippi M, Agosta F, Magnani G, Comi G, Franceschi M, Rainero I, Giordana MT, Rubino E, Ferrero P, Rogaeva E, Xi Z, Confaloni A, Piscopo P, Bruno G, Talarico G, Cagnin A, Clerici F, Dell'Osso B, Comi GP, Altamura AC, Mariani C, Scarpini E. Autosomal dominant frontotemporal lobar degeneration due to the C9ORF72 hexanucleotide repeat expansion: late-onset psychotic clinical presentation. Biol Psychiatry. 2013 Sep 1;74(5):384-91. doi: 10.1016/j.biopsych.2013.01.031. Epub 2013 Mar 7.
PubMed 23473366Vieta E, Popovic D, Rosa AR, Sole B, Grande I, Frey BN, Martinez-Aran A, Sanchez-Moreno J, Balanza-Martinez V, Tabares-Seisdedos R, Kapczinski F. The clinical implications of cognitive impairment and allostatic load in bipolar disorder. Eur Psychiatry. 2013 Jan;28(1):21-9. doi: 10.1016/j.eurpsy.2011.11.007. Epub 2012 Apr 24.
PubMed 22534552Baez S. et al., Neuropsychologia. 2017 Feb 17; S0028-3932(17)30058-1. doi: 10.1016/j.neuropsychologia.2017.02.012.
Delvecchio G. et al., Aust N Z J Psychiatry. 2018 Dec 13:4867418815976. doi: 10.1177/0004867418815976
Neueder A. et al, J Mol Biol. 2018 Dec 29; S0022-2836(18)31287-7. doi: 10.1016/j.jmb.2018.12.012.
Belzil VV, Gendron TF, Petrucelli L. RNA-mediated toxicity in neurodegenerative disease. Mol Cell Neurosci. 2013 Sep;56:406-19. doi: 10.1016/j.mcn.2012.12.006. Epub 2012 Dec 29.
PubMed 23280309Rademakers R, Eriksen JL, Baker M, Robinson T, Ahmed Z, Lincoln SJ, Finch N, Rutherford NJ, Crook RJ, Josephs KA, Boeve BF, Knopman DS, Petersen RC, Parisi JE, Caselli RJ, Wszolek ZK, Uitti RJ, Feldman H, Hutton ML, Mackenzie IR, Graff-Radford NR, Dickson DW. Common variation in the miR-659 binding-site of GRN is a major risk factor for TDP43-positive frontotemporal dementia. Hum Mol Genet. 2008 Dec 1;17(23):3631-42. doi: 10.1093/hmg/ddn257. Epub 2008 Aug 21.
PubMed 18723524Galimberti D, Villa C, Fenoglio C, Serpente M, Ghezzi L, Cioffi SM, Arighi A, Fumagalli G, Scarpini E. Circulating miRNAs as potential biomarkers in Alzheimer's disease. J Alzheimers Dis. 2014;42(4):1261-7. doi: 10.3233/JAD-140756.
PubMed 25024331Fenoglio C, Ridolfi E, Galimberti D, Scarpini E. An emerging role for long non-coding RNA dysregulation in neurological disorders. Int J Mol Sci. 2013 Oct 14;14(10):20427-42. doi: 10.3390/ijms141020427.
PubMed 24129177Ludwig B, Dwivedi Y. Dissecting bipolar disorder complexity through epigenomic approach. Mol Psychiatry. 2016 Nov;21(11):1490-1498. doi: 10.1038/mp.2016.123. Epub 2016 Aug 2.
PubMed 27480490Jin XF, Wu N, Wang L, Li J. Circulating microRNAs: a novel class of potential biomarkers for diagnosing and prognosing central nervous system diseases. Cell Mol Neurobiol. 2013 Jul;33(5):601-13. doi: 10.1007/s10571-013-9940-9. Epub 2013 Apr 30.
PubMed 23633081Fries GR, Walss-Bass C, Soares JC, Quevedo J. Non-genetic transgenerational transmission of bipolar disorder: targeting DNA methyltransferases. Mol Psychiatry. 2016 Dec;21(12):1653-1654. doi: 10.1038/mp.2016.172. Epub 2016 Oct 4. No abstract available.
PubMed 27698432Ghidoni R, Paterlini A, Albertini V, Glionna M, Monti E, Schiaffonati L, Benussi L, Levy E, Binetti G. Cystatin C is released in association with exosomes: a new tool of neuronal communication which is unbalanced in Alzheimer's disease. Neurobiol Aging. 2011 Aug;32(8):1435-42. doi: 10.1016/j.neurobiolaging.2009.08.013. Epub 2009 Sep 20.
PubMed 19773092Sanacora G, Treccani G, Popoli M. Towards a glutamate hypothesis of depression: an emerging frontier of neuropsychopharmacology for mood disorders. Neuropharmacology. 2012 Jan;62(1):63-77. doi: 10.1016/j.neuropharm.2011.07.036. Epub 2011 Aug 3.
PubMed 21827775Jun C, Choi Y, Lim SM, Bae S, Hong YS, Kim JE, Lyoo IK. Disturbance of the glutamatergic system in mood disorders. Exp Neurobiol. 2014 Mar;23(1):28-35. doi: 10.5607/en.2014.23.1.28. Epub 2014 Mar 27.
PubMed 24737937
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the Behavioral Variant of Frontotemporal Dementia and Bipolar Disorder: a Neuroimaging and Epigenetics Integrated Approach
- ClinicalTrials.gov ID
- NCT06706687
- Acronym / sponsor ID
- DISBAND / DISBAND
- Keywords
- Bipolar Disorder (BD), Frontotemporal Dementia, Behavioral Variant (bvFTD), Epigenetics, Neuroimaging, miRNA, Nuclear Magnetic Resonance Imaging (NMR), Nuclear Magnetic Resonance Spectroscopy (1H-MRS), Positron Emission Tomography (PET)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoUniversity, hospital or other
- Study start
- 19 May 2021 (actual)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Apr 2025 (estimated)
- First posted
- 26 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to investigate the selective epigenetic modifications and their effect on brain's morphology and functionality in the frontotemporal dementia behavioral variant and bipolar disorder. The open-label, multicentric, interventional case-control study involves the analysis of 3 separate cohorts of patients, partly selected over the course of the past 10 years. More specifically, 80 behavioral variant Frontotemporal Dementia (bvFTD) patients (40, of whom 20 carry G4C2 expansion in the C9orf72 gene, are already available, while 40 will be prospectively recruited), 80 Bipolar Disorder (BD) patients (40, including 20 with early onset and 20 with late onset, are already available, while 40 will be prospectively recruited) and 50 healthy control (HC) subjects (20 of whom are already available from other previously approved studies), will be enrolled in this study.
For each participant a blood sample will be collected, processed, and studied in order analyze the expression of miRNA. Every participant will also undergo Nuclear Magnetic Resonance Imaging (NMR), Nuclear Magnetic Resonance Spectroscopy (1H-MRS), and Positron Emission Tomography (PET) and, lastly, a battery of behavioral scales to explore different cognitive domains will be administered to all participants by a team of psychologists and physicians. The overall estimated duration of the study is 36 months.
Detailed description
Following the inclusion and exclusion criteria, the participants will be recruited and subdivided into three groups:
- bvFTD patients, followed prospectively for at least 2 years. These include bvFTD carriers of G4C2 expansion in the C9orf72 gene (best model of the two diseases because such expansion is widely associated with the development of psychosis)
- BD patients who are part of a cohort of multi affected families (MAF) followed since January 2017 at the Psychiatry Operating Unit of the Policlinico di Milano and who have positive family history of neurodegenerative diseases.
- Healthy subjects who underwent neurocognitive tests at baseline that excluded the presence of dementia and psychiatric diseases.
The investigators will be collecting participants blood samples, which will be processed and analyzed. More specifically, total exosomes will be isolated from 500 microliters of plasma by ExoQuick precipitation solution (SBI). Isolation and purification of NDEs will be performed by ExoFlow purification kit using biotinylated anti-human CD171 (L1CAM) antibody (clone 5G3, Ebiosciences). Total RNA contained in NDEs will be extracted by Total Exosome RNA and Protein Isolation Kit and miRNA expression analysis by TaqMan OpenArray Human Advanced MicroRNA Panel (Thermo Fisher Scientific). Expression analysis of lncRNAs will be conducted by LincFinder Array and inflammatory and autoimmunity arrays (Qiagen).
The participants will also undergo a neuroimaging session, where structural MRI and 1H-MRS sessions will be performed using a 3T MRI scanner available at the Neuroradiology Unit. The 1H-MRS will provide sensitive and reliable assessment of neurochemical changes in specific brain areas. The acquisition voxels will be palced in the dorso- and ventrolateral prefrontal cortex (DLPFC/VLPFC), amygdala, and hippocampus. Finally, an FDG-PET scan will be performed with a Biograph Truepoint 64 PET/TC scanner. T1-weighted and FDG-PET images will be used to explore brain morphological/metabolic differences between the groups. Gray matter and white matter volumes will be estimated locally and compared between groups using voxel-based morphometry. A parallel region of interest comparison (ROIs) will be performed to estimate regional volumes using the Automated Anatomical Labelling (AAL) atlas as a reference, again focusing on the DLPFC/VLPFC, amygdala and hippocampus. Finally, an additional regional analysis based on Freesurfer software will allow the investigators to estimate the cortical thickness, cortical surface area, and cortical gyrification of the Desikan-Killiany atlas regions. All MRI and PET analyses will be performed in the context of a general linear model using a specific software implementation in MATLAB called Statistical Parametric Mapping (SPM).
Lastly, neuroimaging data and ncRNA expression profiles will be used as predictors in the ML analysis. Given the small sample size, initially linear models (e.g., Support Vector Machine) will be used. Later, to improve the predictive power of our models, the investigators will apply the ML method called random forest, a more versatile and powerful classification algorithm, and the XGBoost (eXtreme Gradient Boosting) algorithm. To avoid overfitting of the learning process, a "grid" search of model hyperparameters will be performed. A 5-fold cross-validation will be used to validate the results, with a split between training-tests of 80%-20%.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Frontotemporal Dementia, Behavioral Variant (bvFTD) | Other | Diagnostic Test: DISBAND protocol |
| Bipolar Disorder (BD) | Other | Diagnostic Test: DISBAND protocol |
| Healthy controls (HC) | Other | Diagnostic Test: DISBAND protocol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- byFTD group: patients of either sex; 18 years of age or older; diagnosis of behavioral variant Frontotemporal Dementia according to current diagnostic criteria; presence of a signed informed consent.
- BD group: patients of either sex; 18 years of age or older; diagnosis of bipolar disorder according to DSM-V criteria; presence of a signed informed consent.
- HC group: patients of either sex; 18 years of age or older; subjects who have gone through the same diagnostic process as patients under suspicion of a central nervous system and/or psychiatric disorder, resulting in the absence of cognitive deficits and mood disorders; presence of a signed informed consent.
Key exclusion criteria (4 listed)
- Diagnosis of Alzheimer's disease
- Comorbidities interfering with the studied condition (e.g. other neurological diseases or history of substance or alcohol abuse)
- Diseases with an inflammatory component (e.g. autoimmune diseases, tumors)
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DISBAND protocolFor each participant blood samples will be collected, processed and studied to analyse microRNA expression, more specifically investigating non-coding RNA (ncRNA). Each participant will undergo a multimodal neuroimaging session, composed of structural MRI, 1H-MRS and PET. | Diagnostic test | Bipolar Disorder (BD), Frontotemporal Dementia, Behavioral Variant (bvFTD), Healthy controls (HC) |
Primary outcome
Identification of ncRNA transcripts and a specific noncoding RNA profile in neuron-derived exosomes
Time frame: 36 months
Identification of ncRNA transcripts and a specific noncoding RNA profile in neuron-derived exosomes in patients with bvFTD and BD
Differences in brain structure in terms of white matter volumes
Time frame: 36 months
Evaluation of the differences in brain structure in terms of white matter volumes comparing the three groups, using structural MRI
Differences in brain structure in terms of gray matter volumes
Time frame: 36 months
Evaluation of the differences in brain structure in terms of gray matter volumes comparing the three groups, using structural MRI
Differences in brain structure in terms of cortical gyrification
Time frame: 36 months
Evaluation of the differences in brain structure in terms of cortical gyrification comparing the three groups, using structural MRI
Differences in brain structure in terms of superficial cortical area
Time frame: 36 months
Evaluation of the differences in brain structure in terms of superficial cortical area comparing the three groups, using structural MRI
Differences in brain structure in terms of cortical thickness
Time frame: 36 months
Evaluation of the differences in brain structure in terms of cortical thickness comparing the three groups, using structural MRI
Differences in brain metabolism
Time frame: 36 months
Evaluation of the differences in brain metabolism comparing the three groups, using FDG/PET
Differences in glutamatergic neurotransmission in the prefrontal-limbic cortex
Time frame: 36 months
Evaluation of the differences in the glutamatergic neurotransmission of the prefrontal-limbic cortex, comparing the three groups, using 1H-MRS
1 secondary outcome
Creation of a machine learning model
Time frame: 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2024.
- Background: PubMed 23473366Galimberti D, Fenoglio C, Serpente M, Villa C, Bonsi R, Arighi A, Fumagalli GG, Del Bo R, Bruni AC, Anfossi M, Clodomiro A, Cupidi C, Nacmias B, Sorbi S, Piaceri I, Bagnoli S, Bessi V, Marcone A, Cerami C, Cappa SF, Filippi M, Agosta F, Magnani G, Comi G, Franceschi M, Rainero I, Giordana MT, Rubino E, Ferrero P, Rogaeva E, Xi Z, Confaloni A, Piscopo P, Bruno G, Talarico G, Cagnin A, Clerici F, Dell'Osso B, Comi GP, Altamura AC, Mariani C, Scarpini E. Autosomal dominant frontotemporal lobar degeneration due to the C9ORF72 hexanucleotide repeat expansion: late-onset psychotic clinical presentation. Biol Psychiatry. 2013 Sep 1;74(5):384-91. doi: 10.1016/j.biopsych.2013.01.031. Epub 2013 Mar 7.
- Background: PubMed 22534552Vieta E, Popovic D, Rosa AR, Sole B, Grande I, Frey BN, Martinez-Aran A, Sanchez-Moreno J, Balanza-Martinez V, Tabares-Seisdedos R, Kapczinski F. The clinical implications of cognitive impairment and allostatic load in bipolar disorder. Eur Psychiatry. 2013 Jan;28(1):21-9. doi: 10.1016/j.eurpsy.2011.11.007. Epub 2012 Apr 24.
- BackgroundBaez S. et al., Neuropsychologia. 2017 Feb 17; S0028-3932(17)30058-1. doi: 10.1016/j.neuropsychologia.2017.02.012.
- BackgroundDelvecchio G. et al., Aust N Z J Psychiatry. 2018 Dec 13:4867418815976. doi: 10.1177/0004867418815976
- BackgroundNeueder A. et al, J Mol Biol. 2018 Dec 29; S0022-2836(18)31287-7. doi: 10.1016/j.jmb.2018.12.012.
- Background: PubMed 23280309Belzil VV, Gendron TF, Petrucelli L. RNA-mediated toxicity in neurodegenerative disease. Mol Cell Neurosci. 2013 Sep;56:406-19. doi: 10.1016/j.mcn.2012.12.006. Epub 2012 Dec 29.
- Background: PubMed 18723524Rademakers R, Eriksen JL, Baker M, Robinson T, Ahmed Z, Lincoln SJ, Finch N, Rutherford NJ, Crook RJ, Josephs KA, Boeve BF, Knopman DS, Petersen RC, Parisi JE, Caselli RJ, Wszolek ZK, Uitti RJ, Feldman H, Hutton ML, Mackenzie IR, Graff-Radford NR, Dickson DW. Common variation in the miR-659 binding-site of GRN is a major risk factor for TDP43-positive frontotemporal dementia. Hum Mol Genet. 2008 Dec 1;17(23):3631-42. doi: 10.1093/hmg/ddn257. Epub 2008 Aug 21.
- Background: PubMed 25024331Galimberti D, Villa C, Fenoglio C, Serpente M, Ghezzi L, Cioffi SM, Arighi A, Fumagalli G, Scarpini E. Circulating miRNAs as potential biomarkers in Alzheimer's disease. J Alzheimers Dis. 2014;42(4):1261-7. doi: 10.3233/JAD-140756.
- Background: PubMed 24129177Fenoglio C, Ridolfi E, Galimberti D, Scarpini E. An emerging role for long non-coding RNA dysregulation in neurological disorders. Int J Mol Sci. 2013 Oct 14;14(10):20427-42. doi: 10.3390/ijms141020427.
- Background: PubMed 27480490Ludwig B, Dwivedi Y. Dissecting bipolar disorder complexity through epigenomic approach. Mol Psychiatry. 2016 Nov;21(11):1490-1498. doi: 10.1038/mp.2016.123. Epub 2016 Aug 2.
- Background: PubMed 23633081Jin XF, Wu N, Wang L, Li J. Circulating microRNAs: a novel class of potential biomarkers for diagnosing and prognosing central nervous system diseases. Cell Mol Neurobiol. 2013 Jul;33(5):601-13. doi: 10.1007/s10571-013-9940-9. Epub 2013 Apr 30.
- Background: PubMed 27698432Fries GR, Walss-Bass C, Soares JC, Quevedo J. Non-genetic transgenerational transmission of bipolar disorder: targeting DNA methyltransferases. Mol Psychiatry. 2016 Dec;21(12):1653-1654. doi: 10.1038/mp.2016.172. Epub 2016 Oct 4. No abstract available.
- Individual participant dataSharing planned: No
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Recruiting
Affective Cognitive Training in Mood Disorders and High-risk Relatives
Major Depressive Disorder (MDD), Bipolar Disorder (BD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Elio Scarpini, Professor principal investigator
UOSD Malattie Neurodegenerative
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DISBAND protocol in people with Bipolar Disorder and Frontotemporal Dementia, Behavioral Variant, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Paolo Brambilla, Professor (02 55035982, paolo.brambilla@policlinico.mi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of ncRNA transcripts and a specific noncoding RNA profile in neuron-derived exosomes (time frame: 36 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06706687, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2024.