Vortioxetine for Frontotemporal Dementia

Overseen By Christopher B Morrow, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Johns Hopkins University

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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

Research Team

Christopher Morrow, M.D.

Principal Investigator

Johns Hopkins University

Eligibility Criteria

This trial is for individuals with early-stage behavioral variant Frontotemporal Dementia (bvFTD) who experience mood symptoms. Participants must undergo clinical assessments, laboratory tests, brain imaging, and cognitive testing before and after a 12-week treatment period.

Inclusion Criteria

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

I am 45 years old or older.

Exclusion Criteria

Negative toxicology screening for drugs of abuse

No contraindications for Magnetic Resonance (MR) scanning (e.g. metal implanted in the body)

History of drug or alcohol dependence within six months prior to study entry

Treatment Details

Interventions

• Vortioxetine (Serotonin Modulator)

Trial Overview The study is testing whether vortioxetine can improve mood and cognitive functions in bvFTD patients. It involves initial and follow-up brain scans (MRI & FDG PET) as well as memory and problem-solving tests to measure changes after the treatment.

Participant Groups

Group I: Patient Treatment Arm (Vortioxetine) Experimental Treatment 1 Intervention

Individuals with bvFTD and mood symptoms receiving the study drug, vortioxetine.

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Lundbeck LLC

Industry Sponsor

Trials

17

Recruited

10,600+