Testing vortioxetine for mood and thinking symptoms in early frontotemporal dementia
Tests vortioxetine for mood and thinking symptoms in early behavioral frontotemporal dementia.
Plain-language title generated from the registry record
Registry title: Vortioxetine for the Treatment of Mood and Cognitive Symptoms in Frontotemporal Dementia
Key facts
- Where
- Baltimore, United StatesSee the site
- Phase
- Phase 2
Where in United States
- The Johns Hopkins HospitalBaltimore, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Johns Hopkins University
- Trial code
- NCT06604520
- Record updated
- 9 March 2026
- Original description
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:Read full original descriptionShow less
Functional Neuroimaging to Examine Affective Symptoms and Cognition 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 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
Inclusion: 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; Male or Female; Age 45 and above; Subjects must be medically stable; Free of psychotropic medications; Competent to provide informed consent.
Exclusion: No history of drug or alcohol dependence within six months prior to study entry; Negative toxicology screening for drugs of abuse; Negative toxicology screening for drugs of abuse; No current or past history of neurological or psychiatric illness or substance abuse; Subject must not be pregnant or nursing; No contraindications to Vortioxetine treatment; No contraindications for Magnetic Resonance (MR) scanning (e.g. metal implanted in the body); Healthy Controls; Subject must not be pregnant or nursing; No contraindications for MR scanning (e.g. metal implanted in the body).
FTD Patients.