Thinking of joining a study?

Register your interest

Become a volunteer?

NCT06604520 | NOT YET RECRUITING | Fronto-temporal Dementia

Vortioxetine for the Treatment of Mood and Cognitive Symptoms in Frontotemporal Dementia
Sponsor:

Johns Hopkins University

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 this study aims to answer are: 1. Do individuals with mood symptoms and bvFTD have brain changes and cognitive profiles that differ compared to individuals without bvFTD? 2. 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

Condition or disease

Fronto-temporal Dementia

Fronto-temporal Lobar Dementia

Frontotemporal Degeneration

Frontotemporal Dementia (FTD)

Frontotemporal Dementia, Behavioral Variant

Frontotemporal Dementia

Intervention/treatment

Vortioxetine

Phase

PHASE2

Study Type : INTERVENTIONAL
Estimated Enrollment : 50 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : Functional Neuroimaging to Examine Affective Symptoms and Cognition in Frontotemporal Dementia
Actual Study Start Date : 2025-01
Estimated Primary Completion Date : 2029-05
Estimated Study Completion Date : 2029-09

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 45 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
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)
    • Vortioxetine for the Treatment of Mood and Cognitive Symptoms in Frontotemporal Dementia

    Location Details

    NCT06604520

    Please Choose a site

    How to Participate

    Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

    Locations

    Not yet recruiting

    United States, Maryland

    The Johns Hopkins Hospital

    Baltimore, Maryland, United States, 21287