Investigating the link between Frontotemporal Dementia and Bipolar Disorder using neuroimaging and epigenetics
A Study of the Behavioral Variant of Frontotemporal Dementia and Bipolar Disorder: a Neuroimaging and Epigenetics Integrated Approach
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 210 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico Academic / other |
| Locations | 1 site (Milan, MI) |
| Trial ID | NCT06706687 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with Alzheimer's disease, other neurological diseases, or significant comorbidities may not benefit from this study.
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 performed: While studies exploring the relationship between neurodegenerative diseases and psychiatric disorders exist, this integrated approach using epigenetics and neuroimaging is relatively novel.
Eligibility criteria
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 this trial is running
Milan, MI
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.