NCT06604520

Vortioxetine for the Treatment of Mood and Cognitive Symptoms in Frontotemporal Dementia

Functional Neuroimaging to Examine Affective Symptoms and Cognition in Frontotemporal Dementia

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 45 Years
• Healthy volunteers: Accepted

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

Conditions

• Fronto-temporal Dementia
• Fronto-temporal Lobar Dementia
• Frontotemporal Degeneration
• Frontotemporal Dementia (FTD)
• Frontotemporal Dementia, Behavioral Variant
• Frontotemporal Dementia

Interventions

Type	Name	Description
DRUG	Vortioxetine	Individuals with bvFTD and mood symptoms will receive approximately 12 weeks of treatment with vortioxetine

Timeline

• Start date: 2025-03-20
• Primary completion: 2029-05-31
• Completion: 2029-09-01
• First posted: 2024-09-19
• Last updated: 2026-03-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study