RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

Functional Neuroimaging to Examine Affective Symptoms and Cognition in Frontotemporal Dementia

Quick Facts

Study Start:2025-03-20
Study Completion:2029-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06604520

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:45 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Male or Female
  2. 2. Age 45 and above
  3. 3. Diagnosis of possible or probable bvFTD based on international consensus criteria for behavioral variant FTD (FTDC)
  4. 4. The presence of at least one of the following affective symptoms on the 12-item Neuropsychiatric Inventory: depression, anxiety, irritability, or agitation
  5. 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. 6. Patients must be medically stable
  7. 7. Vortioxetine treatment is clinically indicated
  8. 8. Competent to provide informed consent
  1. 1. No history of drug or alcohol dependence within six months prior to study entry
  2. 2. Negative toxicology screening for drugs of abuse
  3. 3. Subject must not be pregnant or nursing
  4. 4. No contraindications to Vortioxetine treatment
  5. 5. No contraindications for Magnetic Resonance (MR) scanning (e.g. metal implanted in the body)

Contacts and Locations

Study Contact

Christopher B Morrow, MD
CONTACT
410-502-6509
cmorrow3@jhmi.edu

Principal Investigator

Christopher Morrow, MD
PRINCIPAL_INVESTIGATOR
Johns Hopkins University

Study Locations (Sites)

The Johns Hopkins Hospital
Baltimore, Maryland, 21287
United States

Collaborators and Investigators

Sponsor: Johns Hopkins University

  • Christopher Morrow, MD, PRINCIPAL_INVESTIGATOR, Johns Hopkins University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-20
Study Completion Date2029-09

Study Record Updates

Study Start Date2025-03-20
Study Completion Date2029-09

Terms related to this study

Keywords Provided by Researchers

  • FTD
  • Frontotemporal Dementia
  • Neuropsychiatric Symptoms
  • Antidepressant

Additional Relevant MeSH Terms

  • Fronto-temporal Dementia
  • Fronto-temporal Lobar Dementia
  • Frontotemporal Degeneration
  • Frontotemporal Dementia (FTD)
  • Frontotemporal Dementia, Behavioral Variant
  • Frontotemporal Dementia