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

Condition(s) studied

Investigational drug(s) / intervention(s)

DISBAND protocol: 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 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

Primary outcome measure(s)

• Identification of ncRNA transcripts and a specific noncoding RNA profile in neuron-derived exosomes — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 36 months
  Evaluation of the differences in the glutamatergic neurotransmission of the prefrontal-limbic cortex, comparing the three groups, using 1H-MRS

Trial sites (1)

More Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico trials in Italy

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