NCT06706687 A Study of the Behavioral Variant of Frontotemporal Dementia and Bipolar Disorder: a Neuroimaging and Epigenetics Integrated Approach
| NCT ID | NCT06706687 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico |
| Condition | Bipolar Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 210 participants |
| Start Date | 2021-05-19 |
| Primary Completion | 2025-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 210 participants in total. It began in 2021-05-19 with a primary completion date of 2025-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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
Contact & Investigator
Elio Scarpini, Professor
PRINCIPAL INVESTIGATOR
UOSD Malattie Neurodegenerative
Frequently Asked Questions
Who can join the NCT06706687 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Bipolar Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06706687 currently recruiting?
Yes, NCT06706687 is actively recruiting participants. Contact the research team at paolo.brambilla@policlinico.mi.it for enrollment information.
Where is the NCT06706687 trial being conducted?
This trial is being conducted at Milan, Italy.
Who is sponsoring the NCT06706687 clinical trial?
NCT06706687 is sponsored by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico. The principal investigator is Elio Scarpini, Professor at UOSD Malattie Neurodegenerative. The trial plans to enroll 210 participants.
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