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

NCT06604520 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-03-09

No results posted yet for this study

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

Conditions

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

Interventions

DRUG

Vortioxetine

Individuals with bvFTD and mood symptoms will receive approximately 12 weeks of treatment with vortioxetine

Sponsors & Collaborators

  • National Institute on Aging (NIA)

    collaborator NIH

  • Lundbeck LLC

    collaborator INDUSTRY

  • Johns Hopkins University

    lead OTHER

Principal Investigators

  • Christopher Morrow, MD · Johns Hopkins University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-03-20
Primary Completion
2029-05-31
Completion
2029-09-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06604520 on ClinicalTrials.gov