Recruiting
Phase 2

Vortioxetine

Sponsor:

Johns Hopkins University

Code:

NCT06604520

Conditions

Fronto-temporal Dementia

Fronto-temporal Lobar Dementia

Frontotemporal Degeneration

Frontotemporal Dementia (FTD)

Frontotemporal Dementia, Behavioral Variant

Eligibility Criteria

Sex: All

Age: 45+

Healthy Volunteers: Accepted

Interventions

Vortioxetine

Study Details

Brief 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

Study ID

NCT06604520

Start date

Mar 20, 2025

Status verified date

Mar, 2026

Completion date

Sep 1, 2029

Anticipated

Primary completion date

May 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 45+

Healthy Volunteers: Accepted

FTD Patients

Inclusion Criteria:

1. Male or Female
2. Age 45 and above
3. Diagnosis of possible or probable bvFTD based on international consensus criteria for behavioral variant FTD (FTDC)
4. The presence of at least one of the following affective symptoms on the 12-item Neuropsychiatric Inventory: depression, anxiety, irritability, or agitation
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. Patients must be medically stable
7. Vortioxetine treatment is clinically indicated
8. Competent to provide informed consent

Exclusion Criteria:

1. No history of drug or alcohol dependence within six months prior to study entry
2. Negative toxicology screening for drugs of abuse
3. Subject must not be pregnant or nursing
4. No contraindications to Vortioxetine treatment
5. No contraindications for Magnetic Resonance (MR) scanning (e.g. metal implanted in the body)

Healthy Controls

Inclusion Criteria:

1. Male or Female
2. Age 45 and above
3. Subjects must be medically stable
4. Free of psychotropic medications
5. Competent to provide informed consent

Exclusion Criteria:

1. No current or past history of neurological or psychiatric illness or substance abuse
2. Subject must not be pregnant or nursing
3. Negative toxicology screening for drugs of abuse
4. No contraindications for MR scanning (e.g. metal implanted in the body)

Study Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Patient Treatment Arm (Vortioxetine)

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

Interventions

Vortioxetine

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

Central contacts

Christopher B Morrow, MD

410-502-6509cmorrow3@jhmi.edu

Locations

The Johns Hopkins Hospital

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

Christopher B Morrow, MD

410-502-6509cmorrow3@jhmi.edu

Principal Investigator:

Christopher B Morrow, MD

More Information

Sponsor

Johns Hopkins University

Last update posted

Mar 9, 2026

Last verified

Mar, 2026

Keywords

  • FTD
  • Frontotemporal Dementia
  • Neuropsychiatric Symptoms
  • Antidepressant

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-22. This information was provided to ClinicalTrials.gov by Johns Hopkins University on 2026-03-09.