The goal of this clinical trial is to learn if vortioxetine improves mood symptoms and cognition in patients with early-stage behavioral variant Frontotemporal Dementia (bvFTD). The main questions this study aims to answer are:
1. Do individuals with mood symptoms and bvFTD have brain changes and cognitive profiles that differ compared to individuals without bvFTD? 2. Do mood symptoms and cognition improve following treatment with vortioxetine?
Researchers will also determine whether there are changes in the brain associated with vortioxetine treatment.
Participants will:
* Undergo a screening visit that involves clinical assessments and laboratory tests * Undergo an initial brain magnetic resonance imaging (MRI) and fluorodeoxyglucose (18F) Positron Emission Tomography (FDG PET) scan before starting treatment with vortioxetine * Undergo memory and problem-solving tests before starting treatment with vortioxetine * Undergo approximately 12 weeks of treatment with vortioxetine, during which time there will be regular contact and assessments with the study psychiatrist * Undergo a repeat PET scan and repeat memory and problem-solving tests after 12 weeks of treatment with vortioxetine
Male or Female
Age 45 and above
Diagnosis of possible or probable bvFTD based on international consensus criteria for behavioral variant FTD (FTDC)
The presence of at least one of the following affective symptoms on the 12-item Neuropsychiatric Inventory: depression, anxiety, irritability, or agitation
No history of drug or alcohol dependence within six months prior to study entry
Negative toxicology screening for drugs of abuse
Subject must not be pregnant or nursing
No contraindications to Vortioxetine treatment
Single group
Vortioxetine
DrugIndividuals with bvFTD and mood symptoms will receive approximately 12 weeks of treatment with vortioxetine
Change in global cerebral glucose metabolism on [18F] fluorodeoxyglucose Positron Emission Tomography (FDG PET)
Cerebral glucose uptake measured through 18F FDG positron emission tomography
Change in depressive symptoms as assessed by the Hamilton Depression Rating Scale (HDRS).
The HDRS is a widely used clinician-administered depression assessment tool designed to measure the severity of depression in individuals. It consists of 17 items rated on a 3 or 5 point scale with total scores ranging from 0 to 52. A higher score indicates more severe symptoms of depression.
Change in performance on the Trail Making Test (TST).
The TMT is a widely used neuropsychological test that assesses an individuals cognitive abilities including executive function, attention, processing speed, and mental flexibility. It is divided into two parts: Trail Making Test A and Trail Making Test B. The Trail Making Test A primarily assesses visual attention and processing speed. Time taken to complete the task is recorded, with faster times indicating better cognitive performance. The Trail Making Test B primarily assesses cognitive flexibility, executive functioning, task switching and attention. Time taken to complete the task is recorded, with faster times indicating better cognitive performance.
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Johns Hopkins University
Lead sponsor
National Institute on Aging (NIA)
Collaborator
Lundbeck LLC
Collaborator
