Using vortioxetine to improve mood and cognition in patients with frontotemporal dementia
Functional Neuroimaging to Examine Affective Symptoms and Cognition in Frontotemporal Dementia
This study is testing if a medication called vortioxetine can help improve mood and thinking skills in people with early-stage behavioral variant Frontotemporal Dementia.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 45 Years and up |
| Sex | All |
| Sponsor | Johns Hopkins University Academic / other |
| Locations | 1 site (Baltimore, Maryland) |
| Trial ID | NCT06604520 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of vortioxetine in enhancing mood and cognitive symptoms in patients diagnosed with early-stage behavioral variant Frontotemporal Dementia (bvFTD). Participants will undergo a series of assessments, including brain imaging and cognitive tests, before and after a 12-week treatment period with vortioxetine. The study will also investigate any associated brain changes resulting from the treatment. The primary focus is to determine if mood and cognitive improvements can be achieved through this intervention.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals aged 45 and older with a diagnosis of possible or probable behavioral variant Frontotemporal Dementia and experiencing mood symptoms.
Not a fit: Patients with a history of drug or alcohol dependence, contraindications to vortioxetine, or those who are pregnant or nursing may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the quality of life for patients suffering from mood and cognitive symptoms associated with frontotemporal dementia.
How similar studies have performed: While this approach is novel in the context of frontotemporal dementia, similar studies have shown promise in using antidepressants for cognitive and mood improvements in other dementia types.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Baltimore, Maryland
- The Johns Hopkins Hospital — Baltimore, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Christopher Morrow, MD — Johns Hopkins University
- Study coordinator: Christopher B Morrow, MD
- Email: cmorrow3@jhmi.edu
- Phone: 410-502-6509
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.