Vortioxetine for the Treatment of Mood and Cognitive Symptoms in Frontotemporal Dementia
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 tha
| Condition(s) | Fronto-temporal Dementia, Fronto-temporal Lobar Dementia, Frontotemporal Degeneration, Frontotemporal Dementia (FTD), Frontotemporal Dementia, Behavioral Variant, Frontotemporal Dementia |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| 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 befo |
| Who can participate | FTD Patients Inclusion Criteria: 1. Male or Female 2. Age 45 and above 3. Diagnosis of possible or probable bvFTD based on international consensus criteria for behavioral variant FTD (FTDC) 4. The presence of at least one of the following affective symptoms on the 12-item Neuropsychiatric Inventory: depression, anxiety, irritability, or agitation 5. 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 6. Patients must be medically stable 7. Vortioxetine treatment is clinically indicated 8. Competent to provide informed consent Exclusion Criteria: 1. No history of drug or alcohol dependence within six months prior to stu |
| Ages | 45 Years |
| Sex | All |
| Accepts healthy volunteers | Yes |
| Lead sponsor | Johns Hopkins University |
| Locations | Baltimore, Maryland, United States |
| Start date | 2025-03-20 |
| NCT ID | NCT06604520 |
| Official listing | https://clinicaltrials.gov/study/NCT06604520 |