Functional Neuroimaging to Examine Affective Symptoms and Cognition in Frontotemporal Dementia
Details
Status
Open: Currently recruiting participants.
Closed: Recruitment either has not started or has paused or completed.
Study Type
Interventional (clinical trials): Test treatments.
Observational: Conduct surveys and interviews, study medical records and otherwise observe people or groups over time.
Interventional
Study Phase
Each study phase tests different aspects of the medication or treatment:
- Phase I: safety and dosing
- Phase II: effectiveness and side effects
- Phase III: efficacy compared to standard treatments
- Phase IV: long-term safety after approval for use
Unspecified
Location(s)
Johns Hopkins study sites. Additional study locations may be found on ClinicalTrials.gov.
The Johns Hopkins Hospital
1800 Orleans St Baltimore, MD 21287
Keywords
Contact Us
Clinical Trials Website Interest FormBrief 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 this study aims to answer are:
- Do individuals with mood symptoms and bvFTD have brain changes and cognitive profiles that differ compared to individuals without bvFTD?
- Do mood symptoms and cognition improve following treatment with vortioxetine?
Researchers will also determine whether there are changes in the brain associated with vortioxetine treatment.
Participants will:
- Undergo a screening visit that involves clinical assessments and laboratory tests
- Undergo an initial brain magnetic resonance imaging (MRI) and fluorodeoxyglucose (18F) Positron Emission Tomography (FDG PET) scan before starting treatment with vortioxetine
- Undergo memory and problem-solving tests before starting treatment with vortioxetine
- Undergo approximately 12 weeks of treatment with vortioxetine, during which time there will be regular contact and assessments with the study psychiatrist
- Undergo a repeat PET scan and repeat memory and problem-solving tests after 12 weeks of treatment with vortioxetine
Eligibility
FTD Patients
Inclusion Criteria:
- 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 Criteria:
- 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
Exclusion Criteria:
- No current or past history of neurological or psychiatric illness or substance abuse
- Subject must not be pregnant or nursing
- Negative toxicology screening for drugs of abuse
- No contraindications for MR scanning (e.g. metal implanted in the body)