Vortioxetine for the Treatment of Mood and Cognitive Symptoms in Frontotemporal Dementia (NCT06604520) | Clinical Trial Compass
RecruitingPhase 2
Vortioxetine for the Treatment of Mood and Cognitive Symptoms in Frontotemporal Dementia
United States50 participantsStarted 2025-03-20
Plain-language summary
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
Who can participate
Age range45 Years
SexALL
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Inclusion criteria
✓. 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
✓. A global Clinical Dementia Rating (CDR®) plus National Alzheimer's Coordinating Center (NACC) Frontotemporal lobar degeneration (FTLD) Behavior and Language Domains global score (CDR® plus NACC FTLD) less than or equal to one
✓. Patients must be medically stable
✓. Vortioxetine treatment is clinically indicated
✓. Competent to provide informed consent
Exclusion criteria
✕. No history of drug or alcohol dependence within six months prior to study entry
What they're measuring
1
Change in global cerebral glucose metabolism on [18F] fluorodeoxyglucose Positron Emission Tomography (FDG PET)