Investigating the link between Frontotemporal Dementia and Bipolar Disorder using neuroimaging and epigenetics
Official title: A Study of the Behavioral Variant of Frontotemporal Dementia and Bipolar Disorder: a Neuroimaging and Epigenetics Integrated Approach
Run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico · NCT06706687 · Data updated 2026-11-12
This study is trying to see how changes in the brain and genes might connect Frontotemporal Dementia and Bipolar Disorder by looking at patients with these conditions and healthy people.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 210 (estimated) |
| Sponsor | Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico Academic / other |
| Locations | 1 site (Milan, MI) |
| Status | Recruiting |
| Started | May 19, 2021 |
| Main results expected | January 2025 |
| Study ends | April 2025 |
| Registry record updated | November 26, 2024 |
| Trial ID | NCT06706687 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults aged 18 and older diagnosed with bvFTD or BD, as well as healthy individuals without cognitive or mood disorders.
✕Probably not a fit
Patients with Alzheimer's disease, other neurological diseases, or significant comorbidities may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to explore the epigenetic modifications affecting brain morphology and functionality in patients with behavioral variant Frontotemporal Dementia (bvFTD) and Bipolar Disorder (BD). It is an open-label, multicentric, interventional case-control study that will analyze three cohorts: bvFTD patients, BD patients, and healthy controls. Participants will undergo blood sample collection for RNA analysis and neuroimaging sessions to assess brain structure and function. The study will include both existing and prospectively recruited patients over a two-year follow-up period.
Why it matters
Potential benefit: If successful, this study could enhance understanding of the biological mechanisms linking bvFTD and BD, potentially leading to improved diagnostic and therapeutic strategies.
How similar studies have gone: While studies exploring the relationship between neurodegenerative diseases and psychiatric disorders exist, this integrated approach using epigenetics and neuroimaging is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico
Milan, Mi, Italy Recruiting
Study contacts
- Principal investigator: Elio Scarpini, Professor — UOSD Malattie Neurodegenerative
- Study coordinator: Paolo Brambilla, Professor
- Email: paolo.brambilla@policlinico.mi.it
- Phone: 02 55035982
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.