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

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Johns Hopkins University
Study ID
NCT06604520
Phase
PHASE2
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
45 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Vortioxetine — DRUG
    Individuals with bvFTD and mood symptoms will receive approximately 12 weeks of treatment with vortioxetine

Study Details

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

Key Dates

Start date
Mar 20, 2025
Status verified
Mar 2026
Primary completion
May 31, 2029
Completion
Sep 1, 2029

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Patient Treatment Arm (Vortioxetine)
    Individuals with bvFTD and mood symptoms receiving the study drug, vortioxetine.

Primary Outcome Measure

Change in global cerebral glucose metabolism on [18F] fluorodeoxyglucose Positron Emission Tomography (FDG PET) [ Time Frame: Baseline, 12 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The Johns Hopkins HospitalBaltimoreMaryland21287
Christopher B Morrow, MD
[email protected]
410-502-6509
Christopher B Morrow, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Baltimore, MD

By research site
The Johns Hopkins Hospital· Baltimore, MD

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