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

Launched by JOHNS HOPKINS UNIVERSITY · Sep 17, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a medication called vortioxetine to see if it can help improve mood and thinking abilities in people with behavioral variant Frontotemporal Dementia (bvFTD). The researchers want to find out if individuals with mood problems related to bvFTD have different brain changes compared to those who do not have this condition and whether vortioxetine can make their mood and thinking better. The study will involve brain scans and memory tests before and after about 12 weeks of treatment with vortioxetine, along with regular check-ins with a psychiatrist.

To participate in the trial, individuals need to be at least 45 years old and diagnosed with bvFTD, showing symptoms like depression or anxiety. They also need to be medically stable and able to give informed consent. Healthy volunteers over 45 can join the study too, as long as they don’t have any neurological or psychiatric conditions. Participants can expect thorough assessments, brain scans, and ongoing support throughout the trial. This study aims to improve our understanding of bvFTD and explore potential treatment options for those affected.

Gender

ALL

Eligibility criteria

• • FTD Patients
• Inclusion Criteria:
• • 1. Male or Female
• • 2. Age 45 and above
• • 3. Diagnosis of possible or probable bvFTD based on international consensus criteria for behavioral variant FTD (FTDC)
• • 4. The presence of at least one of the following affective symptoms on the 12-item Neuropsychiatric Inventory: depression, anxiety, irritability, or agitation
• • 5. 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
• • 6. Patients must be medically stable
• • 7. Vortioxetine treatment is clinically indicated
• • 8. Competent to provide informed consent
• Exclusion Criteria:
• • 1. No history of drug or alcohol dependence within six months prior to study entry
• • 2. Negative toxicology screening for drugs of abuse
• • 3. Subject must not be pregnant or nursing
• • 4. No contraindications to Vortioxetine treatment
• • 5. No contraindications for Magnetic Resonance (MR) scanning (e.g. metal implanted in the body)
• • Healthy Controls
• Inclusion Criteria:
• • 1. Male or Female
• • 2. Age 45 and above
• • 3. Subjects must be medically stable
• • 4. Free of psychotropic medications
• • 5. Competent to provide informed consent
• Exclusion Criteria:
• • 1. No current or past history of neurological or psychiatric illness or substance abuse
• • 2. Subject must not be pregnant or nursing
• • 3. Negative toxicology screening for drugs of abuse
• • 4. No contraindications for MR scanning (e.g. metal implanted in the body)