Status:
RECRUITING
Vortioxetine for the Treatment of Mood and Cognitive Symptoms in Frontotemporal Dementia
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
National Institute on Aging (NIA)
Lundbeck LLC
Conditions:
Fronto-temporal Dementia
Fronto-temporal Lobar Dementia
Eligibility:
All Genders
45+ years
Phase:
PHASE2
Brief Summary
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 thi...
Eligibility Criteria
Inclusion
- 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 to one
- Patients must be medically stable
- Vortioxetine treatment is clinically indicated
- Competent to provide informed consent
Exclusion
- 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
- Subjects must be medically stable
- Free of psychotropic medications
- Competent to provide informed consent
Key Trial Info
Start Date :
March 20 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2029
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06604520
Start Date
March 20 2025
End Date
September 1 2029
Last Update
April 2 2025
Active Locations (1)
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1
The Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287