Actively Recruiting
Functional Neuroimaging to Examine Mood and Cognitive Symptoms in Frontotemporal Dementia Using Vortioxetine
Led by Johns Hopkins University · Updated on 2026-03-09
50
Participants Needed
1
Research Sites
13 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
Researchers are studying whether vortioxetine can improve mood symptoms and thinking abilities in people with early-stage behavioral variant Frontotemporal Dementia (bvFTD). The study also aims to find out if brain patterns and cognitive profiles differ between individuals with bvFTD and mood symptoms and those without the condition. This research is sponsored by Johns Hopkins University and is conducted as a Phase 2 clinical trial. Participants will receive about 12 weeks of treatment with vortioxetine, an investigational drug for this condition. Before starting treatment, participants will undergo brain scans including magnetic resonance imaging (MRI) and fluorodeoxyglucose Positron Emission Tomography (FDG PET), as well as cognitive testing focusing on memory and problem-solving. During treatment, participants will have regular contact and assessments with a study psychiatrist. After 12 weeks, brain scans and cognitive tests will be repeated to observe any changes. Throughout the study, participants will be assessed through clinical evaluations, laboratory tests, and memory and problem-solving tests. The main outcome measured is the change in brain glucose metabolism on FDG PET scans from baseline to 12 weeks. Secondary outcomes include changes in depressive symptoms measured by the Hamilton Depression Rating Scale. The total participation time includes screening, 12 weeks of treatment, and follow-up evaluations to monitor safety and treatment effects.
CONDITIONS
Brief 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 mood symptom such as depression, anxiety, irritability, or agitation
- Global Clinical Dementia Rating plus NACC Frontotemporal lobar degeneration Behavior and Language Domains score less than or equal to one
- Medically stable
- Vortioxetine treatment is clinically indicated
- Competent to provide informed consent
You will not qualify if you...
- No history of drug or alcohol dependence within six months prior to study entry
- Negative toxicology screening for drugs of abuse
- Not pregnant or nursing
- No contraindications to vortioxetine treatment
- No contraindications for magnetic resonance (MR) scanning such as metal implants
- No current or past history of neurological or psychiatric illness or substance abuse for healthy controls
- Free of psychotropic medications for healthy controls
- Competent to provide informed consent for healthy controls
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Approximately 12 weeks
Participants receive approximately 12 weeks of treatment with vortioxetine to address mood and cognitive symptoms associated with frontotemporal dementia.
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
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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