NCT06604520RecruitingPhase 2
Vortioxetine for the Treatment of Mood and Cognitive Symptoms in Frontotemporal Dementia
Functional Neuroimaging to Examine Affective Symptoms and Cognition in Frontotemporal Dementia
Source: ClinicalTrials.gov · Last updated 9 Mar 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 17 Sept 2024
- Start date
- 20 Mar 2025
- Primary completion date
- 31 May 2029
- Lead sponsor
- Johns Hopkins University
- Diseases
- Frontotemporal dementia
- NCT number
- NCT06604520
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 50
- From 20 Mar 2025 to the primary completion date, 31 May 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- No current or past history of neurological or psychiatric illness or substance abuse
Other
- 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)
Who the study is looking for
- 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
Criteria the registry did not label
- FTD Patients
Age in the registry: 45 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Johns Hopkins Hospital Coordinator of this site? Confirm its status | Baltimore | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.