NCT06604520 Vortioxetine for the Treatment of Mood and Cognitive Symptoms in Frontotemporal Dementia
| NCT ID | NCT06604520 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Johns Hopkins University |
| Condition | Fronto-temporal Dementia |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2025-03-20 |
| Primary Completion | 2029-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 50 participants in total. It began in 2025-03-20 with a primary completion date of 2029-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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
Eligibility Criteria
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 study entry 2. Negative toxicology screening for drugs of abuse 3. Subject must not be pregnant or nursing 4. No contraindications to Vortioxetine treatment 5. No contraindications for Magnetic Resonance (MR) scanning (e.g. metal implanted in the body) Healthy Controls Inclusion Criteria: 1. Male or Female 2. Age 45 and above 3. Subjects must be medically stable 4. Free of psychotropic medications 5. Competent to provide informed consent Exclusion Criteria: 1. No current or past history of neurological or psychiatric illness or substance abuse 2. Subject must not be pregnant or nursing 3. Negative toxicology screening for drugs of abuse 4. No contraindications for MR scanning (e.g. metal implanted in the body)
Contact & Investigator
Christopher Morrow, MD
PRINCIPAL INVESTIGATOR
Johns Hopkins University
Frequently Asked Questions
Who can join the NCT06604520 clinical trial?
This trial is open to participants of all sexes, aged 45 Years or older, studying Fronto-temporal Dementia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06604520 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06604520 currently recruiting?
Yes, NCT06604520 is actively recruiting participants. Contact the research team at cmorrow3@jhmi.edu for enrollment information.
Where is the NCT06604520 trial being conducted?
This trial is being conducted at Baltimore, United States.
Who is sponsoring the NCT06604520 clinical trial?
NCT06604520 is sponsored by Johns Hopkins University. The principal investigator is Christopher Morrow, MD at Johns Hopkins University. The trial plans to enroll 50 participants.