Actively Recruiting
Vortioxetine for the Treatment of Mood and Cognitive Symptoms in Frontotemporal Dementia
Led by Johns Hopkins University · Updated on 2026-03-09
50
Participants Needed
1
Research Sites
232 weeks
Total Duration
On this page
Sponsors
J
Johns Hopkins University
Lead Sponsor
N
National Institute on Aging (NIA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Vortioxetine for the Treatment of Mood and Cognitive Symptoms in Frontotemporal Dementia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or Female
- Age 45 and above
- Diagnosis of possible or probable behavioral variant Frontotemporal Dementia (bvFTD) based on international consensus criteria
- Presence of at least one affective symptom (depression, anxiety, irritability, or agitation) on the 12-item Neuropsychiatric Inventory
- Global Clinical Dementia Rating (CDR) plus NACC FTLD Behavior and Language Domains global score less than or equal to one
- Medically stable
- Vortioxetine treatment clinically indicated
- Competent to provide informed consent
- For healthy controls: male or female, age 45 and above, medically stable, free of psychotropic medications, competent to provide informed consent
You will not qualify if you...
- History of drug or alcohol dependence within six months prior to study entry
- Positive toxicology screening for drugs of abuse
- Pregnant or nursing
- Contraindications to vortioxetine treatment
- Contraindications for magnetic resonance (MR) scanning such as metal implants
- For healthy controls: current or past neurological or psychiatric illness or substance abuse
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
Actively Recruiting
Research Team
C
Christopher B Morrow, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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