A Study of the Behavioral Variant of Frontotemporal Dementia and Bipolar Disorder Using Neuroimaging and Epigenetics

What this Trial Is About

Researchers are investigating selective epigenetic changes and their effects on brain structure and function in people with behavioral variant Frontotemporal Dementia (bvFTD) and Bipolar Disorder (BD). This open-label, multicenter, interventional case-control study includes three groups: 80 bvFTD patients, 80 BD patients, and 50 healthy controls. Some participants were recruited over the past decade, while others will be newly enrolled. The study aims to explore how these conditions differ in brain morphology and biochemical markers using advanced imaging and molecular techniques over 36 months. Each participant will provide a blood sample to analyze microRNA and other noncoding RNA expressions. They will also undergo brain imaging sessions including structural MRI, proton magnetic resonance spectroscopy (1H-MRS), and FDG-PET scans to assess brain volumes, metabolism, and neurotransmission in specific regions such as the prefrontal cortex, amygdala, and hippocampus. These data will be used alongside behavioral tests and advanced machine learning methods to identify brain and molecular differences among the groups. Participants will be assessed through neurocognitive tests administered by psychologists and physicians. Blood samples will be processed to isolate neuron-derived exosomes for RNA analysis. Imaging data will be analyzed with specialized software to measure gray and white matter volumes, cortical thickness, and metabolic activity. The study's main outcomes include identifying specific RNA profiles and brain structure differences. The total duration of participation is estimated to be 36 months, during which multiple evaluations will take place to monitor changes and build predictive models.

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