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New treatment option for Fronto-temporal Dementia
Official title Vortioxetine for the Treatment of Mood and Cognitive Symptoms in Frontotemporal Dementia
ClinicalTrials.gov ID: NCT06604520
What this study is testing
What is Vortioxetine?
Vortioxetine is an investigational medicine, being studied as a potential treatment for fronto-temporal dementia.
Also referred to as Trintellix.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 45 and older. Healthy volunteers may be eligible.
You may be able to join if
- FTD Patients
- 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...
You likely can't join if
- 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
See the full eligibility criteria
- FTD Patients
- 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...
- Patients must be medically stable
- Vortioxetine treatment is clinically indicated
- Competent to provide informed consent
- 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
- people 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)
The study team makes the final eligibility decision.
Where it's taking place
- Baltimore, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 45 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Baltimore, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.