Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
NCT06706687

A Study of the Behavioral Variant of Frontotemporal Dementia and Bipolar Disorder: a Neuroimaging and Epigenetics Integrated Approach

Led by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico · Updated on 2024-11-26

210

Participants Needed

1

Research Sites

201 weeks

Total Duration

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AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

A Study of the Behavioral Variant of Frontotemporal Dementia and Bipolar Disorder: a Neuroimaging and Epigenetics Integrated Approach

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • bvFTD patients of any sex aged 18 years or older with a diagnosis of behavioral variant Frontotemporal Dementia and signed informed consent
  • BD patients of any sex aged 18 years or older with a diagnosis of bipolar disorder per DSM-V criteria and signed informed consent
  • Healthy control individuals of any sex aged 18 years or older with no cognitive deficits or mood disorders confirmed by diagnostic evaluation and signed informed consent
Not Eligible

You will not qualify if you...

  • Diagnosis of Alzheimer's disease
  • Other neurological diseases or history of substance or alcohol abuse interfering with the study condition
  • Diseases with an inflammatory component such as autoimmune diseases or tumors
  • Pregnancy

AI-Screening

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Trial Site Locations

Total: 1 location

1

Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico

Milan, MI, Italy, 20100

Actively Recruiting

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Research Team

P

Paolo Brambilla, Professor

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

3

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