NCT06604520 · Phase 2 · RECRUITING
Vortioxetine for the Treatment of Mood and Cognitive Symptoms in Frontotemporal Dementia
This trial is testing whether vortioxetine, an antidepressant already approved for depression, can improve mood symptoms and thinking abilities in people with early-stage behavioral variant frontotemporal dementia (bvFTD). Participants get brain scans and cognitive tests before and after 12 weeks on the drug. It is a Phase 2 trial, meaning researchers are still exploring whether it works and is safe in this specific condition — it is not proven or approved for FTD.
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)
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2026-03-09