Functional Neuroimaging to Examine Affective Symptoms and Cognition in Frontotemporal Dementia

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 45
Healthy Volunteers: t
View:

• 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

• Male or Female

• Age 45 and above

• Subjects must be medically stable

• Free of psychotropic medications

• Competent to provide informed consent

Locations
United States
Maryland
The Johns Hopkins Hospital
RECRUITING
Baltimore
Contact Information
Primary
Christopher B Morrow, MD
cmorrow3@jhmi.edu
410-502-6509
Time Frame
Start Date: 2025-03-20
Estimated Completion Date: 2029-09-01
Participants
Target number of participants: 50
Treatments
Experimental: Patient Treatment Arm (Vortioxetine)
Individuals with bvFTD and mood symptoms receiving the study drug, vortioxetine.
Related Therapeutic Areas
Sponsors
Collaborators: Lundbeck LLC, National Institute on Aging (NIA)
Leads: Johns Hopkins University

This content was sourced from clinicaltrials.gov