NCT06604520 · Johns Hopkins University
Vortioxetine for the Treatment of Mood and Cognitive Symptoms in Frontotemporal Dementia
What this study 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.
View original scientific description
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.
Interventions
DRUG
Vortioxetine
Individuals with bvFTD and mood symptoms will receive approximately 12 weeks of treatment with vortioxetine
Primary outcome measures
Change in global cerebral glucose metabolism on [18F] fluorodeoxyglucose Positron Emission Tomography (FDG PET)
Time frame: Baseline, 12 weeks
Cerebral glucose uptake measured through 18F FDG positron emission tomography
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Exclusion criteria
- No history of drug or alcohol dependence within six months prior to study entry
- Negative toxicology screening for drugs of abuse
- 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 Inclusion Criteria:
- Male or Female
- Age 45 and above
- Subjects must be medically stable
- Free of psychotropic medications
- Competent to provide informed consent Exclusion Criteria:
- No current or past history of neurological or psychiatric illness or substance abuse
- Subject must not be pregnant or nursing
- Negative toxicology screening for drugs of abuse
- No contraindications for MR scanning (e.g. metal implanted in the body)
Where
- Baltimore, Maryland
Collaborators
National Institute on Aging (NIA), Lundbeck LLC
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 9, 2026 · Source of record for eligibility and locations