Vortioxetine for the Treatment of Mood and Cognitive Symptoms in Frontotemporal Dementia
Launched by JOHNS HOPKINS UNIVERSITY · Sep 17, 2024
Trial Information
Current as of July 09, 2025
Recruiting
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)
About Johns Hopkins University
Johns Hopkins University, a prestigious research institution located in Baltimore, Maryland, is renowned for its commitment to advancing medical science and public health through innovative clinical trials. With a rich history of groundbreaking research and a multidisciplinary approach, the university's clinical trial initiatives focus on translating scientific discoveries into effective treatments and interventions. Leveraging state-of-the-art facilities and a collaborative network of experts, Johns Hopkins University conducts rigorous clinical studies that aim to improve patient outcomes and address critical health challenges. Its dedication to ethical standards and participant safety underscores its role as a leader in clinical research.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Baltimore, Maryland, United States
Patients applied
Trial Officials
Christopher Morrow, MD
Principal Investigator
Johns Hopkins University
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported